Breast Cancer - Diagenic Announces Launch Of First Breast Cancer Gene-Expression Blood Test

Main Category: Breast Cancer
Also Included In: Cancer / Oncology;  Medical Devices / Diagnostics;  Genetics
Article Date: 10 Nov 2008 - 2:00 PDT

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DiaGenic ASA (OSL: DIAG) and Applied Biosystems Inc. (NYSE: ABI) today 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