Biomarker-based blood test

NEW YORK—Biotech firm BioMarCare Technologies Ltd. and genome firmAriadne Inc. have jointly received a $900,000 grant from the BinationalIndustrial Research and Development Foundation (BIRD) to develop a proteinbiomarker-based pharmacogenomic test for diagnosing colorectal cancer by asimpler, more non-invasive method. The current diagnostic tool used to discovercolorectal cancer is a colonoscopy, an invasive test that many patientsevade—often until it is too late.

The Aug. 2 announcement of what could ultimately turn out to be agroundbreaking diagnostic test was delivered by BioMarCare's parent company,Hadasit Bio-Holdings Ltd., a portfolio of biotech firms based on intellectualproperty, developed and owned by Hadassah University Hospital, consideredIsrael's foremost medical research center.

New York-based BioMarCare and Rockville, Md.-based Ariadne will jointlydevelop a diagnostic test, based on a panel of protein biomarkers, to directthe personal care of patients with metastatic stage colorectal cancer. Currenttreatments for metastatic colorectal cancer are ineffective for a significantpercentage of patients, Hadasit reports. The new test would enable physiciansto detect the non-responders prior to treatment, thus saving patients fromunnecessary treatment.

This method would allow for a more effective course of treatment to beadministered at an earlier stage of the disease, and also predict which patientswould not respond to treatment before it is administered, according to Hadasit.This places the biotechs in line with the more fashionable medical trend towardmore efficient personalized medicine.

Colorectal cancer is the third most common malignant disease worldwide,with more than 1 million new cases discovered annually and more than 30 percentdiagnosed with metastatic stage cancer. One reason colorectal cancer is sodeadly is because many patients do not want to face undergoing unpleasant imagingtests to potentially diagnose colorectal cancer, such as a colonoscopy orsigmoidoscopy.

"There are no biomarker-based blood tests approved today for earlydetection of disease onset, prognosis and recurrence," BioMarCare's websitestates. "Instead, imaging modalities are used for follow-up no sooner than 12weeks after therapy and expose the patient to radiation."

According to the American Cancer Society, colorectal cancer is one ofthe leading causes of cancer-related deaths in the United States. However,early diagnosis often leads to a complete cure.

Cancer has attracted a great deal of interest as the area of choice forthe development of biomarker-based companion diagnostics, BioMarCare reports.Until superior therapeutic treatments are developed to prevent, treat and curecancer, the best means of reducing mortality and morbidity in a disease thiscomplex is early detection and diagnosis. In the major solid cancers, long-termsurvival rates drop precipitously once metastasis has occurred.

Although BioMarCare CEO Dana Cohen could not be reached for comment onthis story, Cohen stated in a news release, "The prestigious BIRDFoundation's grant enables the company to develop a diagnostic product whichwill reduce ineffective treatment of patients and excessive costs to thehealthcare system. Product development with Ariadne Inc. will also extend thecompany's reach to the U.S. market and may be the basis for developingadditional tests to guide treatment of cancer in the future."

If successful, the joint collaboration would have many global marketopportunities, according to BioMarCare. In 2007, approximately 12 million newcancer cases were diagnosed worldwide, and this number is expected to reachmore than 17 million by 2020, the company reports. Cancer testing is one of themost important growth opportunities for the next three to five years. It isexpected to reach a compound annual growth rate of 18 percent.

The global market for biomarkers was $5.6 billion in 2007. Biomarkersare pushing the world market for in-vitro diagnostic teststoward $12 billion by 2012. Also in 2007, the cancer biomarker market accountedfor approximately 55 percent of total biomarker revenues at more than $3billion, with the majority of revenues derived from biomarker discovery andmolecular diagnostics.

The pharma industry is becoming increasingly interested in developingtests that can be used to guide the prescription of cancer therapies, and theU.S. Food and Drug Administration (FDA) has called for more and better biomarkersto accompany clinical studies.

In addition, BioMarCare is also in the process of developing diagnostictools for colon cancer and breast cancer that are based on a simple blood test,the company reports. These tests utilize proprietary biomarkers, licensed fromthe Hadassah Medical Organization's technology transfer company Hadasit, andhave shown high sensitivity even at early stages of the disease.

The BIRD grant is one of nine grants approved for Israeli-Americancollaborations in 2011, and is granted to Israeli and American collaborationsin various fields, not only medical, according to a company news release. Thegrant will be matched by company funds and will be repaid through royaltypayments from the developed product. BioMarCare and Ariadne are in the throesof finalizing their collaboration agreement and will then finalize an agreementwith the BIRD Foundation, as required by the fund.