Nacco proposal with cover letter

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1 June 2009
Ms. K. Sujatha Rao
Secretary & DG, NACCO
New Delhi

Dear Ms Rao,
It gives me a great pleasure to announce that we are introducing for the first time in India
Stimulating Maximal Antibody Response Tube – SMARTubeTM—a new scientific
innovation that may revolutionize HIV & HCV detection and help in saving millions of
lives. It is based Stimmunology-- a breakthrough technology which targets the hidden
antibodies by stimulating specific humeral immune response and overcoming the immune
suppressants of the body. SMARTubeTM is like an early warning radar system for the
detection and diagnosis of HIV and/or HCV infections – in the early stages of the disease
when most tests cannot diagnose it on the basis of antibodies produced in the infected blood.

As a cost effective method SMARTubeTM may increase the SENSITIVITY and SPECIFICITY
of other known HIV & HCV detection devises—with very little additional training or cost
input. Using SMARTube™ may enable earlier, better and complete detection of HIV/HCV just
a week after exposure. Besides detection of all the patients who are diagnosed in the
conventional testing – this may also enable detection of additional patients who are actually
infected, but otherwise remained undetected at that testing time.

SMARTube™ has been clinically tried on over 10,000 patients/individuals in China, USA,
South Africa, Mexico, Israel and Kenya and has been awarded-- CE Mark—the regulatory
stamp of approval for use in the whole of Europe (the EU countries) and is being used in the
hospitals, blood banks and laboratories across Germany, Russian Federation, South
Africa, Israel, Romania, Nigeria, and Turkey wherever blood requires to be tested for HIV
and/or HCV. SMARTubeTM can detect both HIV and HCV.

All this makes SMARTubeTM – the smart and the ultimate weapon of choice to attack
and fight against the killer twins – HIV & HCV-- both of whom are smart and lethal
invaders – and masters in the art of camouflage, deception and hidden combat after
silently crippling the defenders – inside the human body.
• It’s a world wide trend that many HIV infected -- medically undiagnosed people are
walking the on streets blissfully unaware of their HIV+ve status. They are like potential
Human Time Bombs that can explode any moment causing irreparable damage by
actually infecting 100 s of other innocent and unsuspecting people
• Given the trend that only less than 1 % population of India get themselves tested for
HIV-HCV even once in the lifetime and worst still up to 27 % HIV infected people remain
undiagnosed… Can India be left to the mercy of these killer twins- HIV & HCV?
• It is not a just medical but human rights issue related to the right to live and stay away
from any accidental HIV contamination

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• The only alternative before India which is already home to one of the highest number of
HIV+ve and AIDS related orphans in the world – is to detect and segregate the carriers of
the deadly killer twin diseases – HIV & HCV before its too late.
• Eliminating false –ves may be the only way to realistically combat HIV-HCV menace
• Early and confirmed diagnosis of HIV/HCV – even before antibodies in the blood can be
taken as evidence – may prove to be a turning point for better management of the infection
besides U-turn towards damage control and possible recovery.

SMARTube™ Benefits include:
• Enables early detection than any other existing methods, within days of exposure
• Simple, effective, affordable and reliable- Saves lives and suffering
• Requires no changes to the existing testing procedures
• Increases Sensitivity and Specificity
• Cost effective – Saves: Money, Time, Resources

SMARTubeTM has the potential to transform the lives of millions of faceless men,
women and children of India – the so-called Aam Admi—both in terms of active
contributors as well as passive sufferers of the disease; housewives, pregnant women,
new born babies, corporate employees and all the high risk HIV+ve categories like sex
workers, gays, IDUs and truck drivers besides having a positive impact on the Defense
and Paramilitary forces, Blood banks, blood transfusion sector and the hospital/
healthcare sectors.

From the Indian perspective SMARTubeTM may prove to be extremely useful in sectors like
HIV testing centers, Clinics and laboratories, Diagnostics (hospitals, labs), Epidemiology
(governments, health organizations), Research (vaccine design & therapeutics). Plasma
industry, Health & Life insurance companies, Defense & Police forces – Pre-recruitment
screening as well as in-service monitoring, Individuals & Corporate– Government & private
sector employees, Foreign tourists, healthcare workers, Pregnant women, IDUs, MSMs and
Sex workers

As a pre-condition for granting import license – the Drug Controller of India’s office requires a
recommendation from NACCO about the usefulness of SMARTubeTM.

We seek NACCO’s all-out support and guidance not only in terms of a favorable
recommendation but also in terms of fast track clearance and approvals to bring this
technology to India and ultimately strengthen NACCO’s efforts in this direction.

Assuring you of our best cooperation at all times.
For Society for Medicare

(Neeraj Mahajan)
Secretary

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Executive Summary

The SMART Solution

INDIA needs

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It’s a game of
Death & Disaster
which
THE KILLER TWINS want us to Lose…
INDIA cannot be left at the mercy of HIV/AIDS – HCV
Close to anywhere between
2.4 – 5.7 million HIV+ve people & 165,000 reported AIDS cases
4,000,000 Men, 1,600,000 Women & 1,20,000 children -- already living with HIV
In addition to this, Hepatitis C virus (HCV) accounts for one-fourth of all cases of chronic
liver disease causing 1.5 -2 million deaths in Indian Homes.

DANGER 1: Some 550,000 HIV patients have already developed AIDS and another 300,000 a
year will develop AIDS over the next 15-20 years

DANGER 2: At least 600 new HIV infections in India every hour. Close to 21,000 children
getting newly infected & 30,000 HIV+ve babies being born every year

DANGER 3: As per World Bank estimates India already has 2 million children – the largest
number AIDS orphans in the world-- expected to double in next five years.

DANGER 4: HCV or hepatitis C is known as "silent killer". Deaths from HCVare expected to
triple in the next 10-20 years. The death toll is likely to surpass that of AIDS and could
reach more than a million by 2020.

DANGER 5: About 18 million people in India — most of whom do not know they are
infected, are estimated to be infected with HCV. A quarter of them are likely to develop
chronic liver disease in the next 10 to 15 years.

Prevention – is the only Cure against HIV/ AIDS & HCV!!

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The war against THE KILLER TWINS-- HIV & HCV— cannot be won with the hands tied
behind the back… INDIA needs SMART WEAPONS.

• Both HCV and HIV are silent killers --almost symptom-less blood-borne diseases, caused
by RNA viruses. Both – are smart virus which manage to evade the body’s defense
mechanism and cause irreprable damage internally—till its too late. Till date -- there is
no complete cure or vaccine for both HIV & HCV which replicate at an alarming rate,
once inside the body —producing anywhere between 10 billion (in case of HIV virus
each) to about 10 trillion new viral particles each day (HCV virus). The issue is how to
attack and fight against these smart and lethal invaders – who are masters in the art of
camoflage, deception and hidden combat after silently crippling the defenders – inside
the human body.
• As many as half of all people with HIV are likely to be coinfected with HCV which is four
times more prevalent and ten times more infectious than HIV, which causes AIDS.
• Also despite the World Health Organization’s alarming projection that HCV already
infects approximately 180 million people worldwide— India is so far yet to declare a
“High Alert” against the killer HCV-- on its prevantive Health radar screen—like
HIV/AIDs. The issue is how do we fight against a disease we know little about?

• Roughly 14 % of HIV+ves in India are children below 14 years—unable to protect
themselves.

• According to the Center for Disease Control (CDC) more than 25% of HIV+ve people in
USA are unaware of their HIV status. Healthy in appearance and feeling fine-- they do
not receive proper care and unknowingly pass the HIV virus to others.

• The trend worldwide, including India is that many people are blissfully unaware of their
HIV- HCV + ve status and continue infect others while leading normal lives simply
because–
They do not have any visible or apparent symptoms of HIV/AIDS - HCV
They never felt the need to get tested
It is not a fashionable for people to get HIV – HCV tests done, even once a lifetime
Stigma attached with going for a HIV test (what will people say!), unless unavoidable

Above all, only less than 1 % population of India get themseleves tested for HIV-HCV even
once in the lifetime and worst still upto 27 % HIV infected people remain undiagnosed…

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• According to WHO more than double i.e. as against 5.1 million Indians suffering from
HIV, around 12 million have HCV. And about 30 per cent of HIV +ve are co-infected with
HCV. HIV - HCV co-infection can be extremely complicated with more severe side effects
and repercussions during treatment.
• Hepatitis has become a leading cause of death, perhaps the No. # 1 cause of death, in
HIV today. Since HIV can accelerate the progression of HCV, it is important not to delay
the diagnosis of HCV and the assessment of the stage of liver disease.
• One thing that both HIV & HCV share in common is the window period i.e. the early
stage of the infection when none of the available tests can detect their presence. The
incubation period of HCV infection is 2-26 weeks i.e., the symptoms may take this much
time to appear after a person has been infected. It may take as long as 5-10 years for an
infected person to develop chronic liver disease after exposure to the virus.
• The financial cost of HIV and HCV treatment is beyond the means of the average
citizens. The bottom line is that if infected people are treated and treated early, the
epidemic will prove far less costly in terms of lives, quality of life, and healthcare costs.
• Early detection can often mean a more successful chance at treatment if the situation is
right for one to begin the complex drug regimen.
• Early detection of HCV can significantly lower healthcare costs by preventing high-risk
practices and decreasing virus transmission.
• Early detection of HIV – HCV is also helpful as treatment options and outcomes may be
vary depending on the stage of infection
• Early diagnosis and management may limit the fatality and the spread of the illness.
Early treatment can restore immune response against HCV and help eliminate the virus
rapidly.
• According to a new study published in the Journal of Virology, Canadian researchers
have shown that patients, who receive early treatment for Hepatitis C virus (HCV) within
the first months following an infection, develop a rapid poly-functional immune
response against HCV similar to when infection is eradicated spontaneously. Researchers
from University of Montreal have observed that success rates among those treated early
after infection are significantly higher— around 90 percent.

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• Early diagnosis can reduce the risk of blood-borne infections among individuals who
take drugs or engage in high-risk behaviors putting themselves and others at risk for
contracting or transmitting hepatitis C (HCV), hepatitis B (HBV), tuberculosis (TB), as well
as sexually transmitted diseases, like syphilis, chlamydia, trichomoniasis, gonorrhea, and
genital herpes. IDUs are also susceptible to skin infections at the site of injection as well
as bacterial and viral infections, which can lead to serious health problems.
• Early detection can prevent further transmission of HIV/HCV from mother to child
• Newly infected individuals have a very high viral load— which in other words means that
people are highly infectious at a time when they may still be unaware they have HIV
• IN CONCLUSION: besides helping in timely intervention and effective management of
the HIV & HCV, their early detection is highly desirous from the following points of view:
National & International Interest– savings in economic and healthcare costs

HIV +ve / HCV +ve Individuals:
As a result of early detection, counseling and treatment can start early
Better chances of success in terms of treatment, better and more options
Lesser chances of side effects and complications

Other Individuals:
Lesser chances of unknowingly getting the infection from an infected
person
Lesser chances of mother to child transmission
Lesser chances of acquiring the infections due to exposure to unsafe
blood in hospitals and organ transplantation centers
Safer blood transfusion

High Risk Categories: Early detection of disease in every HIV/HCV positive
individual may prevent further transmission of the diseases in at least 10 other
Injection Drug Abusers & Addicts
Hemophiliacs / Thalassemia patients
Blood Donors
Armed Forces & Para Military force personnel-who share barracks, razors
Female Sex workers and Men having sex with men

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The SMART Solution

v

INDIA needs

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SMARTubeTM being introduced for the first time in India – is a simple, yet revolutionary
breakthrough in medical technology for early warning and detection of HIV & HCV infections
in human beings, months before any other known test or diagnostic method.

Stimulating Maximal Antibody Response Tube – SMARTube™ will revolutionize HIV & HCV
detection by enabling one of the earliest and complete detection of HIV/HCV just a week
after exposure. SMARTube™ not only enables the detection of all the patients who are
diagnosed in the conventional testing - but also enables detection in additional patients that
are infected, but otherwise would have gone undetected at that testing time. As a cost
effective method that increases the SENSITIVITY and SPECIFICITY of other known HIV & HCV
detection devises—with very little additional training or cost input, it will help in saving
millions of lives.

SMARTube™ is manufactured under strict ISO 9001:2000 and ISO 13485:2003 regulations
and the highest global Quality Control, R&D and professional standards. SMARTube™ has
been awarded-- CE Mark—the regulatory stamp of approval in the whole of Europe (the EU
countries) and is certified for public and individual use in Germany, Russian Federation,
South Africa, Israel, Romania, Nigeria, and Turkey. It is being used in these countries in
hospitals, diagnostic labs, blood banks, health or life insurance uses—anywhere blood
samples need to be tested for HIV.

SMARTube™ has been tested in controlled clinical trials on over 10,000 patients/individuals
in several countries like China, Israel, Kenya, Mexico, Romania and South Africa. Most of
these clinical trials and tests were done by reputed government agencies, blood banks,
reference laboratories, academic and professional bodies.

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Background:
Window Period or the Latent Period— when even +ve appears –ve

If a person tests negative for HIV or HCV – it doesn’t mean that he/she is not infected. On
the contrary he/she might be in the most contagious stage of the infection. Such a person
could well infect as many as 50 -100 others before actually testing positive – months later.
This is due to the “Window Period”.

To understand how this window period affects us… we have to first understand how our
body responds to infections and virus attacks … The Human body is made up of about a 100
million cells. Just one teaspoon of blood contains about 25 billion red blood cells. The
immune system is the body's main line defender against infection and illness. It recognizes
the body's cells and tries to get rid of anything unfamiliar. It destroys parasites and germs -
bacteria and viruses.

In case of most infections, the immune system sees the foreign invaders and starts
producing antibodies. Usually it takes 5-7 days for the antibodies to develop. Antibodies
help out in detecting infection before the liver or lungs are affected. However, in case of HIV
and HCV--it could take weeks or up to many months before any antibodies are detected in
the blood.

The only reliable way to tell whether someone has HIV is through blood tests, which can
detect the infection. Most of the HIV –HCV detction tests available today detect the
antibodies in the blood instead of the virus itself. In case of both HIV and HCV it can take
weeks or months after infection before antibodies against are detected. This infected yet
serum-negative period is called the “window period”-- or the most deceptive phase when
even HIV – HCV infected people will be considered non-infected simply because they have
not yet produced or developed detectable levels of antibodies in their blood.

As long as there are no antibodies, these patients are diagnosed as non-infected. This is
called the window period - the time between infection and the detection of antibodies. It is
a major cause for concern among the health authorities, professionals, blood banks, vaccine
and drug developers all over the world, as many infected individuals test negative for HIV or
HCV antibodies, and are thus misdiagnosed. Shortening the window period actually holds
the key to saving millions of lives, billions of dollars, untold human resources, suffering, and
deaths.

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This is where SmartubeTM – based on a simple technology called Stimmunology helps out by
stimulating the in-vitro antibody production in the blood sample, prior to testing for HIV
(and/or HCV). SMARTube™ HIV & HCV, enables the detection of HIV and HCV infections
(during the window period) by overcoming, in vitro, the specific immune suppression
exerted by the virus. The process involves placing 1ml of blood sample inside the
SMARTube™ for a 3-5 day incubation period, leading to the formation of HIV and/or HCV
antibodies in detectable levels in all those infected, including those in the window period.

SMARTube™ Benefits include:

• Enables early detection of HIV & HCV– within days of exposure
• Simple, affordable and reliable
• Requires no changes to the existing testing procedure
• Saves lives and suffering
• Proven effective
• Cost effective – Saves: Money, Time, Resource
• Increases sensitivity & specificity

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Q . What is SMARTubeTM ?

A. The name SMARTubeTM being introduced for the first time in India – is derived from:
S –timulating,
M-aximal
A-ntibody
R-esponse
T-ube
It is a simple, yet revolutionary breakthrough in
medical technology for early warning and
detection of HIV & HCV infections in human
beings, months before any other known test or
diagnostic method.

Q . What is its Unique Selling Proposition - USP ?

A. The main USPs of SMARTubeTM are as under:

1. It simulates the production and growth of a higher level antibodies in the blood
sample—upto a level that can be easily detected by the dignostic tests.
2. False negetive becomes positive: The same tests which had otherwise given a false
negetive report – can now give a confirmed positive result
3. Earliest possible detection of HIV-HCV within days of the infection.
4. Eliminate chances of a false positive results- SMARTubeTM could prove to be a medical
blessing in terms of eliminating the possibility of doubt and reduce the incidence of false
positive result in some of the existing tests.
5. Reduces the period of uncertianity-- You don’t have to wait for weeks or months for the
body to produce antibodies in the due, natural course.
6. Increases the Specificity and Sentivity of the existing tests
7. No additional cost for add-on test-lab infrastructure or training of technicians.

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Q . Why is something like SMARTubeTM the SMART solution to India’s needs?

A. One of main purpose behind any dignostic test – is to act like an early warning radar
system to detect the presence of invading germs and virus before they can cause irrepareble
damage to the human body.

However despite advancement of technology, one problem with most aviation radars is that
they cannot detect low flying, light aircraft. Likewise most HIV/HCV diagnostic tests can
detect only the antibodies produced against the infections and not the actual virus… This is
a major problem as during the window period –or the deceptive dark period just after a new
infection—many infected individuals could go undetected due to false negetive test results
due to low or inadequqte antibodies produced in the human body.

Even in case of a normal viral infection it takes 5-7 days for the antibodies to develop after
the infection. In case of both HIV or HCV it could take weeks or many months before any
antibodies could be found in the blood.

Using the radar terminology-- SMARTubeTM is like an early warning radar system for the
detection and diagnosis of HIV and/or HCV infections – in the early stages of the disease
when most tests cannot diagnose it on the basis of antibodies produced in the infected
blood.

SMARTubeTM is a scientifically engineered -- medical
boon– which makes it possible to detect an HIV carrier
even during the so-called window or latent period of the
infection.

All this makes SMARTubeTM – the smart and the ultimate weapon to attack
and fight against the killer twins – HIV & HCV both of whom are smart and
lethal invaders – and masters in the art of camoflage, deception and hidden
combat after silently crippling the defenders – inside the human body.

Putting things in perspective—

• It’s a world wide trend that many HIV infected though medically
undiagnosed people are actually walking the on streets blissfully unaware
of their HIV+ve status. They are like potential Human Time Bombs that can
explode any moment causing irreparable damage by actually infecting 100s
of other innocent and unsuspecting people

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• Given the trend that only less than 1 % population of India get themseleves
tested for HIV-HCV even once in the lifetime and worst still upto 27 % HIV
infected people remain undiagnosed… Can India be left to the mercy of
these Zombies !!

• It is not a just medical but human rights issue very much akin to the right to
live and stay away from any accidental HIV contamination

• The only alternative before India which is
already the home to one of the highest
number of HIV+ve people and one of the
highest number of AIDS related orphans in
the world – is to detect and segregate the
carriers of the deadly killer twin diseases – HIV & HCV before its too late.

• Ignorance is not bliss—Eliminating the false –ves as well as false +ves -- is
the only way to realistically combat the HIV-HCV menance

• Early and confirmed diagnosis of the HIV/HCV careers – well before the
antibodies in their blood can be taken as evidence – may actually prove to
be a turning point in their lives leading to a better management of their
infection besides the U-turn towards the road to damage control and
possible recovery.

In this sense-- SMARTubeTM is +vely the solution India needs…

Q. Medically which are the sectors where the use of SMARTubeTM could prove to be a
blessing in disguise?

A. SMARTube could prove to be extremely useful in Hospitals, laboratories, research centres
and the blood banks where everyday hundreds of new donors come to donate blood. None
of them is carrying a sign board on their faces – that they are HIV+ve. And if it's been just 2-
3 days before they have been infected by say visiting a prostitute or injectable drug abuse –
none of the existing test would be able to confirm the presence of virus in their blood. This
is where SMARTube can help. Besides this SMARTubeTM could prove to be really useful in
the Army, Airforce, Navy and other central and state police forces as well as large
corporates both in terms of pre-recruitment screening and periodic in-service monitoring of
the HIV status.

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Q. What can be the various uses and applications of SMARTube in India?

A. SMARTube can have uses and applications in many sectors like:
• HIV testing centers
• Clinics and laboratories
• Diagnostics (hospitals, labs)
• Epidemiology (governments, health organizations)
• Research (vaccine design & therapeutics).
• Plasma industry.
• Health & Life insurance companies.
• Army, Police & Police – Pre-recruitment screening
• Individuals & Corporate -- Pregnant women, Healthcare workers, Foreign travelers,
Sex workers

Q. What are the risks involved if all the carriers of the HIV virus are not detected well in
time?

A. HIV and HCV carriers can be identified by detecting the antibodies against the virus in
their blood. After the HIV infection has set in, diagnosis is made using a blood test to detect
antibodies to the virus or copies of the virus itself.

Most HIV tests measure the antibodies produced by the body against HIV. It takes some
time for the immune system to produce enough antibodies for the antibody tests to detect.
This can vary from person to person. Most people develop detectable antibodies within 2
to 8 weeks (the average is 25 days). Even so, there is a chance that some individuals will
take longer to develop detectable antibodies. Therefore, if the initial HIV test was
conducted within the first 3 months of possible exposure, there is a great possibility of a
false-negative result. The length of this period varies from person to person, and depends
on a wide range of factors, such as the amount of HIV present in the bloodstream, general
health, the presence of other illnesses, and the response to treatment. During the
asymptomatic period, the virus is far from inactive. It is constantly replicating and causing
damage to the immune system.

Blood donated at blood banks during the ‘window period’ test negative and hence can be
transfused into unsuspecting patients – requiring urgent blood tranmission – for instance
in cases of accidents, surgeries or say for instance pateients of heomophilia or thalesemia.
Imagime the magnitiude of the problem if every such person requiring blood transfusion
for one reason or the other came back infected with HIV+ve virus.

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This phenomenon that came to prominence in the mid ’90s when people tested and
diagnosed as ’sero-negative’, went out and infected others. You can’t infect somebody if
you’re not infected – that’s when the realization came that there was something wrong with
the present tests which could not diagnose everybody.

Ninety-seven percent people usually develop antibodies in the first 3 months of the
infection. In some rare cases, it may take up to 6 months to develop antibodies to HIV.
The only alternative is the RNA test which can detect the HIV virus directly. Even the time
between HIV infection and RNA detection is 9–11 days. However these tests, are more
costly and used less often than antibody tests.

Researches show that every unidentified carrier could infect, directly and indirectly, some
fifty people a year.

• In the Latent or Window period – when infected people are still serum-negative – i.e.
they do not have enough anti-bodies in their blood that could be detected by any
conventional tests. At this stage, they pose a greater risk to their community because:

They continue infecting others without any precautions.
They think they have a “certified immunity” as they engaged in high risk behavior
and yet did not get infected.

• Blood Banks – blood units donated by donors during the “window period” could get
transfused into unsuspecting patients thus infect them.

• Epidemiological studies- are incomplete, as critical information as to the true rate of
new infections is missing for incidence calculations in a study population.

So in conclusion we can say:

• SMARTube– has opened up newer possibilities for fool-proof diagnosis of HIV or HCV
• SMARTube has reduced the suspense and made it possible to take on HIV in the
earliest stage of progression of the infection in the body.
• SMARTube will help save millions of innocent lives by early diagnosis of high risk
carriers
• SMARTube– will help to eliminate doubt and reduce the incidence of false-positive
results in most of the existing tests. Imagine the trauma of a person and his family
members who has been falsely diagnosed as HIV+ve.

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Q. What is the technological background behind SMARTubeTM and how is ito be used?

A: SMARTube enables antibody production, in a small blood sample, within days from
infection, without having to wait for the body to produce antibodies weeks or months later.
The technology is the culmination of more than 12 years of work by Jehuda-Cohen, an
immunologist with a PhD in immunology from the Technion - Israel Institute of Technology.
The core of the technology is overcoming the specific immune suppressants of the body. It is
a simple three step process.

Step 1: A few drops of blood are placed into the SMARTubeTM which is like a sealed test
tube with a pink coloured plasma solution inside it. This plasma solution gives a false sense
of security to the invading virus to grow without bothering about suppression by the body’s
immune system. In this way the it simulates an extremely fast process of antibody
production.

Step 2: The solution inside the SMARTubeTM is allowed to incubate at 370C for 3-5 days

Step 3: The end result– even routine test by any of the existing methods can now detect a
suffiecient level of antibodies of HIV+ve virus in the same the individuals still in the very
early stages of the window period- who was earliar misdiagnosed as a false negetive. So to
say SMARTube makes it possible to reverse the false positive or negetive as the case may be
much before any other technology today can detect the virus inside the body.

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Q. How does the detection process using SMARTubeTM compare with regards to some of
the other known methods ?

A. This can be explained with the help of the following diagrams which clearly indicates that
SMARTubeTM allows the earliest detection of the HIV & HCV at the most affordable cost

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Q. Why SMART? What is so smart about SMARTube?

A. Well this is because the HIV virus itself is a smart virus, just
around 100-150 billionths of a meter in diameter that it is
about 0.1 microns or 4 millionths of an inch in size. Unlike most
bacteria, it is much too small to be seen through an ordinary
microscope, yet it manages to trick and evade the body's
defenses. Once the Smart HIV virus takes hold, the
immune system can never fully get rid of it and the
HIV+ve person may not even know that they are
infected and may look and feel perfectly well for
many years. But deep inside the immune system
becomes weak and increasingly vulnerable to even
minor illnesses which a normal person can easily fight off.

To fight such a smart virus, you really have to be SMART. Though inside the human body,
the Smart HIV/HCV virus can conceal its presence for a fairly long time by inhibiting the
immune system's ability to produce antibodies from 30-90 days in case HIV or 70-180 days
in case of HCV— the proprietary plasma solution inside the SMARTube is able to see
through this game.

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So it gives a false sense of security to the HIV/HCV virus by convincing it to grow as there are
no immune system cells inside the SMARTube trying to attack it. This encourages the virus
to grow and the blood sample to develop antibodies against it during the incubation phase.
Once the incubation of 3-5 days is over, enough anti-bodies have been developed by the
blood sample inside the SMARTube that even a routine ELISA test – which 3-5 days back
gave a false negative report—can now confirm the seroconversion. It's a warfare in which
the SMARTube technology manages to outsmart the opponent i.e. the HIV/HCV virus.
SMARTube enables antibody production, in a small blood sample, within days from
infection, without having to wait for the body to produce antibodies weeks or months later.

Q. What is the technological basis behind SMARTube and what is it called?

A. SMARTube is based on a unique and innovative technology called Stimmunology-- a
breakthrough technology that holds the key to detect hidden antibodies by
stimulating specific humeral immune response. The core philosophy behind
this technology is to overcome the specific immune suppressants of the
body. A few drops of blood are placed into the SMARTube and a solution
inside helps the cells of the immune system to overcome the suppression
and pushes them into an extremely fast process of antibody production. The
end result– We can detect those individuals already infected when nobody
else can - because they’re still at the very early stages of the window period-
when no other technology today can detect them.

Q. What does SMARTube actually contain?

A. SMARTube is a pretreatment test tube that holds two ml of a pink colored proprietary
liquid solution which is sterile in nature and has a shelf life of six months when kept at 2-8o
C. Before use, SMARTube is brought to room temperature and 1ml of whole blood collected
in heparin is introduced into it.

Q. Does it require extraordinary laboratory apparatus; space required or specifically trained
technicians to conduct the test using SMARTube?

A. There is no specific requirement for any special laboratory equipment except an
incubator which is usually present in any diagnostic or testing laboratory. For tests using
SMARTube we also do not need any extra space in the laboratory where just one ml of
blood is required to be collected. This too any normal trained technician can collect. The
blood sample for the SMARTube can be collected in any of the following ways:
• Direct draw – directly into the vacuum packed SMARTubes in the laboratory

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• Indirect draw – using heparin wash tubes or syringes and later transferring it in the
laboratory into the SMARTube using sterile pipette.

The blood sample thus collected by any of the above methods is transferred inside the
SMARTube and incubated at 37oC in a humidified CO2
incubator for 5 days. After incubation a sample of the
supernatant is removed for testing using any currently
available method for HIV/HCV testing.

The greatest advantage of this cutting edge technology is the
flexibility and simplicity of use, enabling the collection of
blood even in remote places. The blood sample thus
collected can be transferred to the SMARTube even a day
later, when it reaches the testing lab. Since it is a blood pre-
treatment device, once the blood is treated in the SMARTube
it can be tested using any HIV or HCV antibody ELISA tests.
Therefore the labs do not need to change their way of
diagnosing the infection, they only change the way the blood
is handled prior to the tests. This makes the SMARTube very
simple to use -- with great return for the money and better
detection of infected individuals.

Q. How long does it take for the test results using SMARTube?

A. Usually the blood sample inside the SMARTube has to be incubated at 5% CO2 and 37oC
for 3–5 days in a humidified CO2 incubator. For the blood banks, the protocol for using
SMARTube is 3 days. Towards this end a validation and implementation protocol has been
developed by experts in the field.

Q. Does SMARTube require any specific diagnostic platform? What will happen to the
existing and available tests?

A. SMARTube does not require any specific diagnostic method to be adopted. It is a pre-
testing device which does not replace or make diagnostic test redundant. It only improves
or accelerates the development of antibodies to enable early antibody detection using ELISA
(or other antibody test methods). During the incubation period, in-vitro antibody production
is accelerated to such an extent that even regular tests become completely effective. Hence
SMARTube only enables earlier, better and complete detection of HIV/HCV, while excluding
the chances of false negative of false positive reports.

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Q. Does SMARTube substantiate any International quality control and production
standards?

A. SMARTube is manufactured under strict ISO 9001:2000 and ISO 13485:2003 regulations
and highest globally acceptable Quality Control, R&D and professional standards.

Flag Country Certificate

European
CE Mark-EU
Union

Russian Registration
Federation Certificate

Israel AMAR Certificate

Registration
South Africa
Certificate

Registration
Romania
Certificate

Nigeria DOR Registration

SMARTube has been awarded-- CE Mark—the regulatory stamp of approval for
registration and marketing as a blood collection and pre-treatment device in the whole of
Europe. It has also been permitted and certified for public and individual use in Germany,
Russian Federation, South Africa, Israel, Romania and Nigeria. It is now being reviewed by
FDA (USA) for use in hospitals, diagnostic labs, blood banks, health or life insurance uses—
basically anywhere blood samples need to be tested for presence of HIV. Proceedings are
also on for implementation by prestigious world bodies like World Heath Organization,
Family Health Initiative (FHI) and the International AIDS Vaccine Initiative (IAVI).

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Q. Has SMARTube been clinically tried? If so what were the results?

A. SMARTube has been tested in controlled clinical trials on over 10,000 patients/individuals
in several countries like China, Israel, Kenya, Mexico, Romania and South Africa. Most of
these clinical trials and tests were done by reputed government agencies, blood banks,
reference laboratories, academic and professional bodies.

Extracts of Clinical Trials in different parts of the world :

Clinical studies of the HIV&HCV SMARTube™ for HIV/HCV have been performed in
• China
• USA.
• South Africa,
• Mexico,
• Israel,
• Kenya

Country Sample Size Trial Agency

Department of Cell Biology, National
Institute for Control of Pharmaceutical and
China 6,000 approx Biological Products (China). Trials
conducted in five different regions of
China.
HIV 2,000, high risk
Israel
HCV 300
HIV 2,000, blood units
Kenya
HCV 300 , blood units
Mexico HIV 200 High Risk approved government agency
South Africa HIV 90 High Risk

China: Clinical Trials in China were conducted, executed and reported by the Department of
Cell Biology, National Institute for Control of Pharmaceutical and Biological Products. The
trials were done in 5 different regions in China (Total samples tested: approximately 6,000).

1. Trial in high risk population (IVD) in Sichuan District:
HIV
• 653 individuals tested.
• 149 Seropositive.
• 151 Seropositive after pre-treatment in the SMARTube™.

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HCV

2. Trials in blood banks: HIV
• Beijing Blood Bank: 2000 low risk samples, no positives.
• Clearance of false positives by the SMARTube™.

U.S.A : Studies were performed in monkeys. naïve monkeys were infected with a very low
dose of SIV virus (the equivalent to HIV in monkeys).

• 4 monkeys tested.
• 4 seronegative (one week from infection).
• 4 Seropositive after pre-treatment in SMARTube™ (one week-
infection).
All monkeys seroconverted between 1-5 months from infection.

South Africa: Clinical trials were carried out in South Africa among high risk population
(blood donors):
HIV
• 3 Seropositive.

Mexico : Clinical trials were carried out in Mexico, by an approved government agency.
HIV
• 200 Individuals tested, very high risk, multiple, current exposures.

Israel : Several high risk populations were screened using the SMARTube™ as a blood pre-
treatment device in a number of trials (total: over 2,000 individuals).
1. Immigrants from High risk areas:
HIV
HCV
• 1 Seropositive

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2. Low risk populations were screened using the SMARTube™:
HIV
• Over 1,500 individuals tested – no positives.
HCV
• Over 600 individuals tested – no positives.

Kenya : Clinical trials were carried out in Kenya.
1. Screening of high risk population:
HIV

2. Additional trials conducted in the blood bank in Kenya for complete detection
of HIV infected blood units:
HIV
Adults:
Youth:
HCV
• Over 300 individuals tested.

3. A study was conducted on pregnant women:
HIV
• 40 Seronegative women tested.
• 8 out of the 40 Seronegative women, were positive after pre-
treatment in the SMARTube™.

Based on these clinical trials the following observations were recorded:

• After pre-treatment with SMARTube: 1.4% to 40.0% additional positives
• All seropositives are positive after SMARTube
• Increase in specificity
• No adverse affect on specificity
• 30% to-95% reduction in false positive rate

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• Increase in antibody levels in low seropositives (and new ones)
• Safer blood transfusion – detection of infected blood units missed by current
serology
• More efficient detection.
• Less repeat testing, less blood units lost
• Saving in terms of time & money– with improvement in performance.
• Better indication of incidence rates-- rate of new cases versus prevalence (rate of
positives, total).

Q. What are SMARTube's plans for India?

A. Initially SMARTube test kits will be imported into India, later as the demand grows,
SMARTube will be manufactured in India for the domestic market as well as exports to
neighboring countries in the region.

Q. How much are tests using SMARTube likely to cost in India?

A. It is still too early to predict the final costs, which would depend on many factors like
quantities to be imported, infrastructure, logistics and operational costs. A fair idea of the
actual cost could only be worked out after the final codal formalities of registration and
import license as completed—still we estimate the cost to consumer should be around Rs
1000 per test – which is very reasonable considering the fact without SMARTube it takes –
atleast 2-3 different types of tests – which consume much more time and money to
positively diagnose or rule out HIV in India, today.

Q. Who are the people behind importing SMARTube technology into India?

A. The vision and moving spirit behind SMARTube operations and import into India – is Dr
Narendra.K. Gupta – a Indian born US & Canadian citizen who is President of the Society for
Medicare as well founder President & CEO of the Eternal Health & Wellness Foundation
(USA).

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The Team Composition is as follows:

Name Designation Brief Background
Dr Narendra K. President – Society Medical Director & CEO, Diabetes &
Gupta for Medicare Hypertension Center, Duluth, GA,
MD, FRCP(C) Founder President &
CEO, Eternal Health Member: Vascular Biology working Group
& Wellness University of Gainesville, Florida.
Foundation (USA)
Principal Investigator: Multiple Trials on
Diabetes, Hypertension and cardiovascular
diseases.

Clinical Associate Professor of Medicine,
Medical College of Ohio, Toledo

Research Grant: Merck & Co., Novartis
Pharmaceuticals, and Takeda

Consultant Nephrologist - Regina General
Hospital, Canada

America’s Top Physician— 2007 Award by
the Consumer Council of America

Yisrael Serok – Founder and CEO, Yisrael Serok has over 20 years experience in
SMARTube Bio managing small and large scale operations,
both in Israel and other parts of the world.

With a world-wide and established network
of government and strategic relations, he is
on the Board of Directors of several
companies with investment portfolio in a
variety of projects.

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Dr. Tamar Jehuda- Founder and CTO, With in-depth experience in immunology,
Cohen SMARTube Bio diagnostics and AIDS, Dr. Jehuda-Cohen is the
inventor of Stimmunology technology. She
holds over 10 patents, has authored over 30
publications, and more than 100 abstracts—
many of them as presentations at
international conferences.

Dr. Tamar is currently serving as a consultant
for the Family Health Initiative (FHI), funded
by the UNAIDS. Dr Tamar holds Ph.D in
Immunology and cell Differentiation from the
Technion Medical school, Haifa Israel and
completed post doctoral studies at Emery
University in Atlanta, home of U.S Centers for
Disease Control and Prevention.

Neeraj Mahajan Secretary, Society A media professional with over 20 years
for Medicare and experience, proven competence and
Country Head consistency in Print, Electronic, Web or New
(India), Eternal media as well as Corporate Communications,
Health & Wellness PR, Image building and Perception
Foundation (USA) Management. He has held various
assignments in print and electronic media
from staff reporter to Editor (Print) &
Producer-Director (TV).

He specializes in image building and has
conceptualized and executed various
propaganda, counter-propaganda and
Perception Management and psychological
operations for the Indian Army in counter-
insurgency areas in J&K and North East.

Rakshak video magazine– produced and
directed by him was recognized as the official
medium for audio-visual communications of
Indian Army.

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Case Study # 1 : Diagnosis by default-- Jacob Johnes – a US marine never thought he could
contract HIV, despite risky behavior… A routine HIV test confirmed him as sero-negetive till
a doctor who had heard of Smartube decided to test again. It took 48 hours for the HIV
antibodies to develop in vetro and Jones was declared HIV +ve… Imagine how many people
he could have infected

Case Study 2: A baby saved: Mayama was 22 when she came to the antenatal clinic. This
was her third pregnancy, yet her first visit to that clinic. She has come because her friend
told her that she could save her baby if would go there. She was five months pregnant, and
the nurse explained the risks of transmitting HIV to the un-born baby, and that there was
medicine that could save the baby form getting AIDS. Mayama was tested for HIV, using a
rapid test, which was negative.

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The nurse explained that such a result does not mean that she is not infected for sure, as
she could have been infected in the last few months, and then the test will not detect it yet.
Mayama was worried. She was sure one of her regular clients on the truck route was sick
with

AIDS and seeing she got pregnant… When she shared her fears with the nurse she was told
that she could come back in 3 months or so and re-test. Mayama wanted to know. She was
worried, and she really wanted to give that baby the best chance possible. “I cannot wait for
3 months; if I am infected I want to take the medicine now. In three months I will give birth,
it will be too late. Plus, I cannot come back here heavy with pregnancy – everyone will talk!
The nurse shrugged her shoulders. “There is nothing we can do for you now. We cannot see
the infection during the window period, when the virus is hiding and the tests are negative.
Mayama started crying. The head nurse took her into her office. “There is a new way we can
use to see if you are infected, even if it happened recently. But for that we need to draw
blood and send it to the laboratory in town. The results will come back next week. You will
need to come back then, and if you're positive we will give you the ART.”

Mayama agreed to come back. A test tube with her blood was sent to the laboratory. There
they treated the blood with the SMARTube™, an innovative blood pre-treatment which
closes the window period and thus eliminates the false negative results in the early stages of
the infection. On the fifth day, the lab sent the results back to the clinic. While negative on
the tests using the regular methods, Mayama was clearly positive after the SMARTube™
was added to the testing in the laboratory. When Mayama came back, she got the results
with tears of fear and a smile of relief. She was going to save her baby; she was going to get
the drugs to protect him from the virus that has invaded her. As she was walking out of the
clinic, holding on to the medicine for both her and for the baby, when it will be born, she
turned around and ask the head nurse “How do they do it, there in the laboratory? How can
see what is still hidden”. “Well” answered the nurse, “
it is as if they go behind the stage and peak into the
dressing rooms, this way they know about the actors
even before they get on stage”. Mayama gave birth to
healthy baby girl.

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Case Study 3: If we only knew! Katub had her fifth child less than a year after she
immigrated to Israel. Upon arrival her whole family had their blood tested for different
things, including HIV. Her husband was the only one that tested positive for HIV. He figured
he must have gotten it in the camp on route to Israel. Katub was upset, but relieved for
herself and the unborn baby. The baby was born slightly underweight, but pink and
beautiful. When he was six months old he had a bad cold that would not go away. Then, the
doctor said it was probably some infection in the lungs. The antibiotics did not help. The
baby was hospitalized, but could not be saved. In the blood tests, he was found to be HIV
positive, but it was too late, he died of lung infection typical to AIDS patients.

The doctors were upset “If only you would have told your doctor that you are HIV positive,
you could have saved that baby. We know how to treat these type of infections, we just do
not suspect it in a baby without an HIV record.” Katub was very bewildered. How could she
transmit HIV to her baby if she is not infected? Did they not tell her in the immigration
center that she tested negative? She told the doctors it must be a mistake. “No”, said the
young doctor, “it is not a mistake. Unfortunately we cannot detect the HIV infection in the
first few months. You must have gotten infected shortly before the pregnancy, this is why
the results were negative, but it was not a true negative result.

A year later, in a scientific-medical conference, An immunologist presented some interesting
results with a new method which enables the detection of those infected even when still
missed by regular testing in the first months of infection. She called the method
“Stimmunology”, as it stimulates the immune system in the blood sample to “tell” us about
the infection “right away”. “I would like to share with you some alarming results we got
when studying some families with one seropositive HIV carrier. We used the Stimmunology
process for stimulating antibody production even in blood samples form infected individuals
during the window period. This was we can detect them using the regular diagnostic
antibody tests.” On the screen appeared results
showing seronegative wives who were actually
infected, and their infected babies. The doctors in the
audience sighed “If only we would have known”.

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Case study 4: Building a new relationship -- Seth and Diane decided to move in together
and formalize their relationship. They both went together for HIV testing, and, to their relief,
both tested negative. Because of their lifestyle, Seth’s doctor recommended to do an
additional blood test using an experimental pre-treatment of the blood in the university
laboratory. They agreed. The following week the doctor called them in for consultation and
told then that using the experimental new technology; Seth was found to be infected with
HIV. “It must be a recent encounter, in the last half a year or so” said the doctor. “But it is
still experimental, right” said Seth hopefully… Diane was silent all the way home. They have
been together for some time now, she wanted to believe Seth that “it could not be”, yet she
insisted that for their future they should use precaution “Just for the next few months. The
window period is not forever, right?” Three months later, Seth tested positive in a routine
testing.

Case Study 5: Organ donor -- Sheila has been waiting for a kidney transplant for 2 years. The
phone finally rang with the news – “we have a donor”. The young motorcyclist was brain
dead and his family agreed to donate his organs. A battery of tests was run, including HIV
and HCV antibody tests. All came negative. Additional testing was using very sensitive
molecular biology techniques to detect the virus even before the antibody tests detect the
infection. They were negative for both HIV and HCV. Sheila got the kidney, and stayed on
immunosuppressive drugs to reduce the risk of rejection of the transplanted kidney. Less
than a year later, Sheila was diagnosed with HIV and HCV infection. The source of the
infection was the transplanted kidney. All the recipients from that donor were now
positive for HIV and HCV. When Sheila sued the hospital the doctors testified that they have
used all known measures for testing the donor for these infectious and deadly viruses. “But
even with the most sensitive tests, there is a window period in which we cannot detect the
infection, and this window period can take three to six months and sometimes even longer”
testified the laboratory expert. “So there is nothing that could have been done?” asked
Sheila’s lawyer. “Well, responded the expert “there is a way to eliminate that window
period. It is a simple system of pre-treating the blood in a way that expresses the antibodies
prior to their appearance in the body. It works like
magic; it exposes those early infections we currently
miss.” “So if you would have used that method, you
would have been able to prevent all those terrible
infections! Why did you not use it?!”. “We do, but only experimentally, and unlinked, as it
has not yet been approved for use in our country...” responded the expert.

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ROAD MAP TO SMART BENEFITS

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Follow Up Questions / Clarifications:

Finally, please do not hesitate to contact us with whatever
technical or practical questions or comments you might have.
We would be happy to help out with whatever data, analyse
and share our thoughts and ideas.

For More Details Contact:

1. Dr Narendra K. Gupta
President
Society for Medicare.
Founder President & CEO
Eternal Health & Wellness
Foundation (USA)
Email: eternal.wellness.foundation@gmail.com

2. NEERAJ MAHAJAN
Secretary
Society for Medicare &
Country Head (India),
3. Eternal Health & Wellness Foundation (USA)
4. Email: n2erajmahajan@gmail.com
5. Mob: 9999989066, 9818666863

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