announced the launch of BCtect(TM), a blood-based test for early detection of
breast cancer. The test searches for a unique gene expression signature
identified by DiaGenic using a custom TaqMan(R) Array manufactured for
DiaGenic by Applied Biosystems. India was chosen as the first country for the
introduction of BCtect(TM) after successful completion of a large study in
the country.
The DiaGenic BCtect(TM) test addresses a significant medical need in
India, where breast cancer is the second leading cause of death among women.
The lack of a coordinated national screening program means that breast cancer
is typically detected at a late stage, resulting in high mortality rates
compared to Western countries. Last year alone, nearly 100,000 women in the
country died from the disease. Breast cancer is also on the rise, with an
estimated 250,000 new cases expected in India by 2015. A key problem has been
the detection of only 10% of cases at an early stage, which lags far behind
Western countries where detection rates reach as high as 65%.
Studies show there is more than a 90% chance of surviving breast cancer
if detected at an early stage, whereas the mortality rate reaches 90% if this
disease is caught at a very late stage. Clinical studies performed on a group
of Indian women by DiaGenic have shown that the test can detect tumors early
and accurately, in particular among younger (pre-menopausal) women and those
with dense breasts.
DiaGenic launched BCtect(TM) at a special event in New Delhi. Speaking at
the launch, DiaGenic CEO Erik Christensen, M.D. Ph.D., said that the company
decided to launch the test in India because of the interest generated by its
large clinical study across the country, which confirmed the test's gene
signature is unaffected by ethnic variation.
"We hope that by introducing a test that uses peripheral blood rather
than tissue from the actual breast, more women will be encouraged to come
forward for testing," said Dr. Christensen. "In addition, we see BCtect(TM)
filling a gap where mammography is not readily available."
More details on the selection of India as the first market for the new
product were given by Praveen Sharma, Ph.D., co-founder of DiaGenic. "The
results from our Indian study showed that the gene set, previously identified
in Scandinavian and US cohorts, also had similar good diagnostic and
predictive performance in the Indian population. BCtect(TM) is not affected
by ethnic variation or menopausal state of the patient, allowing for
widespread use to diagnose breast cancer at an early stage."
The TaqMan Array manufactured for DiaGenic by Applied Biosystems consists
of 96 TaqMan(R) Gene Expression Assays pre-loaded multiple times on a
384-well micro fluidic card. These 384 simultaneous real-time PCR reactions
are performed without the need to use liquid-handling robots or multichannel
pipettors. The array is run on the Applied Biosystems 7900HT Fast Real-time
PCR System by Labindia.
"We continue to demonstrate our commitment to providing scientists with
the molecular tools they need to develop important diagnostics," said Peter
Dansky, president of Applied Biosystems' functional analysis division.
"The TaqMan Arrays provide an ideal format for surveying gene expression
markers based in their easy-to-use format, high sensitivity, and ability to
facilitate standardization among laboratories for consistent and reliable
results."
The DiaGenic BCtect(TM) breast cancer test will be marketed in India
through Religare SRL (formerly known as SRL Ranbaxy), the largest laboratory
chain in South East Asia. Sanjeev K. Chaudhry, M.D, CEO of SRL predicts high
demand for the DiaGenic test.
"We believe that BCtect(TM) will provide the perfect incentive for women
to take charge of their health and undergo regular check-ups," said Dr.
Chaudhry. "Religare SRL will put in place intensive and extensive
market-facing strategies to ensure rapid growth in the market, both locally
and internationally, and will invest substantial amounts and efforts to
inform the market on the availability of this new innovative test."
The DiaGenic BCtect
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