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

Monday, November 10, 2008 General News
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OSLO and FOSTER CITY, California, November 10 DiaGenic ASA (OSL: DIAG) and Applied Biosystems Inc. (NYSE: ABI) todayannounced the launch of BCtect(TM), a blood-based test for early detection ofbreast cancer. The test searches for a unique gene expression signatureidentified by DiaGenic using a custom TaqMan(R) Array manufactured forDiaGenic by Applied Biosystems. India was chosen as the first country for theintroduction of BCtect(TM) after successful completion of a large study inthe country.
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The DiaGenic BCtect(TM) test addresses a significant medical need inIndia, where breast cancer is the second leading cause of death among women.The lack of a coordinated national screening program means that breast canceris typically detected at a late stage, resulting in high mortality ratescompared to Western countries. Last year alone, nearly 100,000 women in thecountry died from the disease. Breast cancer is also on the rise, with anestimated 250,000 new cases expected in India by 2015. A key problem has beenthe detection of only 10% of cases at an early stage, which lags far behindWestern countries where detection rates reach as high as 65%.
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Studies show there is more than a 90% chance of surviving breast cancerif detected at an early stage, whereas the mortality rate reaches 90% if thisdisease is caught at a very late stage. Clinical studies performed on a groupof Indian women by DiaGenic have shown that the test can detect tumors earlyand accurately, in particular among younger (pre-menopausal) women and thosewith dense breasts.

DiaGenic launched BCtect(TM) at a special event in New Delhi. Speaking atthe launch, DiaGenic CEO Erik Christensen, M.D. Ph.D., said that the companydecided to launch the test in India because of the interest generated by itslarge clinical study across the country, which confirmed the test's genesignature is unaffected by ethnic variation.

"We hope that by introducing a test that uses peripheral blood ratherthan tissue from the actual breast, more women will be encouraged to comeforward 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 newproduct were given by Praveen Sharma, Ph.D., co-founder of DiaGenic. "Theresults from our Indian study showed that the gene set, previously identifiedin Scandinavian and US cohorts, also had similar good diagnostic andpredictive performance in the Indian population. BCtect(TM) is not affectedby ethnic variation or menopausal state of the patient, allowing forwidespread use to diagnose breast cancer at an early stage."

The TaqMan Array manufactured for DiaGenic by Applied Biosystems consistsof 96 TaqMan(R) Gene Expression Assays pre-loaded multiple times on a384-well micro fluidic card. These 384 simultaneous real-time PCR reactionsare performed without the need to use liquid-handling robots or multichannelpipettors. The array is run on the Applied Biosystems 7900HT Fast Real-timePCR System by Labindia.

"We continue to demonstrate our commitment to providing scientists withthe molecular tools they need to develop important diagnostics," said PeterDansky, president of Applied Biosystems' functional analysis division.

"The TaqMan Arrays provide an ideal format for surveying gene expressionmarkers based in their easy-to-use format, high sensitivity, and ability tofacilitate standardization among laboratories for consistent and reliableresults."

The DiaGenic BCtect(TM) breast cancer test will be marketed in Indiathrough Religare SRL (formerly known as SRL Ranbaxy), the largest laboratorychain in South East Asia. Sanjeev K. Chaudhry, M.D, CEO of SRL predicts highdemand for the DiaGenic test.

"We believe that BCtect(TM) will provide the perfect incentive for womento take charge of their health and undergo regular check-ups," said Dr.Chaudhry. "Religare SRL will put in place intensive and extensivemarket-facing strategies to ensure rapid growth in the market, both locallyand internationally, and will invest substantial amounts and efforts toinform the market on the availability of this new innovative test."Corporate Inquiries Erik Christensen, Managing Director DiaGenic ASA, Grenseveien 92, NO-0663 Oslo, Norway Tel +47-95939918 Email: [email protected] Media Inquiries For Applied Biosystems: Renaldo Juanso Applied Biosystems Tel +1-650-638-5354 Email: [email protected]

SOURCE DiaGenic ASA and Applied Biosystems Inc.
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