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Product Name: Molecular Imaging
Product Description
ThromboView is a special type of diagnostic
imaging agent which is being developed by Agenix. It will be used by groups of
radiologists who practice in nuclear medicine. As the name suggests, ThromboView
is a product to help doctors better and more accurately detect blood clots or
thrombus in the body. An injection of ThromboView given to a patient with blood
clots will enable doctors to view the thrombus by seeing hotspots appear on a
type of imaging camera.
How does it work?
There is a protein found on
active blood clots called D-dimer. D-dimer has a unique shape owing to its
biological structure. The matching protein in ThromboView is a perfect
complementary fit for D-dimer. This protein is an antibody and we call it 3B6.
The 3B6 in ThromboView is itself bound to a substance called technetium, which
is a tag or label that nuclear medicine cameras can detect. When ThromboView is
injected, the 3B6 antibody seeks out and finds D-dimer on a blood clot and binds
very tightly. The technetium tag is bound tightly as well. If blood clots are
present, the bound technetium will light up the imaging camera where the clots
are present.
The protein part of ThromboView is essentially a
very specific carrier of the technetium tag to sites of blood clots in the body.
ThromboView will let the doctor know whether to
treat the patient by confirming that clot is present or whether to consider an
alternative diagnosis by confirming that clot is absent. How accurate
ThromboView is in helping doctors make that decision is currently the focus of
clinical trials.
What diseases will ThromboView target?
Patients have disease when there are blood clots
present in the bloodstream. Blood clots often cause damage by obstructing blood
flow to the target organ (eg. clots in the coronary circulation cause myocardial
infarction). When clots are present in the patient's venous circulation, they
are said to be suffering thromboembolism. Thromboembolism is a complex disease
process with two clinical manifestations: deep venous thrombosis (DVT) and
pulmonary embolism (PE). It is a significant health burden particularly with an
aging population, and much research effort has been directed at improving
diagnostic and treatment strategies over the past 10 years. ThromboView will
principally help doctors diagnose DVT and PE.
DVT is often known as "Economy Class Syndrome"
and is caused by blood clots forming in the legs. All sorts of people can
develop DVT, not just travellers: for example, people with heart conditions,
obese people, people post-surgery or women post-pregnancy. Just getting old
increases your risk substantially!It is important to diagnose DVT quickly so
that treatment can be started without delay. DVT is managed with drugs called
anti-coagulants, also known as blood-thinning drugs. Therapy is often for a long
period of time particularly if a patient gets many episodes of clotting because
of underlying health problems. Because these drugs can cause serous problems in
their own right, doctors are very keen to make sure the right diagnosis is made.
PE is a considered a more acute and serious
condition than DVT and is caused by blood clots lodging in the lungs. It is
thought that all PE arises from clots in the legs breaking free from the vein
wall and travelling through the circulation until they reach the lungs. Clots
can be big or small. Large clots which "embolise" or break free can cause death
within a short space of time due to the impact of a large blockage on blood flow
through the heart and oxygen transport to critical organs such as the brain.Most
PE are not massive and there is usually enough time to make a diagnosis and put
in place suitable treatment options. The treatment is the same as for DVT and
doctors have the same concern to get the diagnosis right so they don't expose
patients to unnecessary risk.
Pulmonary Embolism is actually the third most
common cause of cardiovascular death in the USA, causing approximately 60,000
deaths per year.
This is more than the number who die annually of
breast cancer.
Why is there a need for ThromboView?
The methods currently used to detect blood clots
have limitations. No one test is suitable for all patients in all situations.
The most widely-used methods to detect blood clots are ultrasound exams,
ventilation-perfusion scans and computed tomography (CT) scans. Ultrasound is
typically used to diagnose blood clots in the legs, while ventilation-perfusion
scans are used to diagnose clots in the lungs. CT is also used to diagnose clot
in the lungs.
The shortcomings are many. For example,
ultrasound can often not distinguish between new clots and the scar tissue from
old clots and is not a good technique for lower leg DVT. It is also a difficult
technique to use in obese patients and patients with trauma to the legs can
often not tolerate this procedure. Ventilation-perfusion scans have limited
accuracy, with about 7 out of 10 patients requiring further tests to confirm or
rule out the diagnosis. CT scans are increasingly used but carry a high
radiation dose, often equivalent to the dose of 400 x-rays or more. ThromboView
has the potential to improve diagnostic accuracy in a wide variety of patients
and allow doctors to make better- informed treatment decisions.
What can be the result of these shortcomings?
Undetected or untreated blood clots can cause
serious health problems and can be life-threatening. But by the same token,
over-treatment of patients with anticoagulant drugs, when there is only
suspicion of blood clots can endanger life as well. Doctors are very concerned
to ensure an accurate diagnosis is made when patients present with symptoms of
DVT or PE.
Inaccurate results can arise from technical
error. For example, an ultrasound exam on a morbidly obese patient is
technically very difficult as the veins are unable to be adequately compressed
to make a diagnosis. Inaccuracies might also arise from "artefacts" or things on
the scan which appear to be one thing and are actually another. It is difficult
for doctors to identify small clot in the small blood vessels of the lungs and
in the calf veins. Some patients have a lot of other health problems, which
means the doctor has very limited options for diagnosis eg. a patient with renal
failure. Of course doctors try and minimise sources of error constantly. But
still there are many patients in which getting a definitive result is difficult
and ThromboView will offer a test, which is very specific for clot and can be
used on a wide variety of patients.
ThromboView Key Facts
- Undetected blood clots are a significant
medical problem resulting in poor health outcomes for patients.
- ThromboView is a diagnostic imaging product,
being developed by Agenix Ltd, which will help doctors to better diagnose blood
clots in the body.
- Doctors need an improved test to diagnose blood
clots early and accurately. ThromboView is being developed to meet significant
unmet needs in the clot-imaging market.
- There are no recent Australian studies of the
occurrence of thromboembolism in the general community. However. US and European
studies give incidence rates which when applied to the Australian context mean
there are approx:
i. 33 000 cases of Deep Vein Thrombosis(DVT)/year
in Australia (160/100,000)
ii. 4 200 cases of symptomatic Pulmonary Embolism(PE)/yr (20/100,000)
iii. 10 500 cases of autopsy detected fatal PE/yr (50/100,000)
- We also know that there are about 60,000
deaths/yr attributable to PE in the US making this a more common cause of death
than breast cancer. 2,000,000 people suffer DVT.
- Thromboembolism is the third most common cause
of cardiovascular death after heart attack and stroke
Company Details
• This company produces medical and veterinary diagnostic products based on monoclonal antibody technology. Special fields include human haemostasis and infectious diseases.
Agenix Limited was listed on the Australian Stock Exchange in October... more
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