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Biomarker-based blood test
NEW YORK—Biotech firm BioMarCare Technologies Ltd. and genome firm Ariadne Inc. have jointly received a $900,000 grant from the Binational Industrial Research and Development Foundation (BIRD) to develop a protein biomarker-based pharmacogenomic test for diagnosing colorectal cancer by a simpler, more non-invasive method. The current diagnostic tool used to discover colorectal cancer is a colonoscopy, an invasive test that many patients evade— often until it is too late.
The Aug. 2 announcement of what could ultimately turn out to be a groundbreaking diagnostic test was delivered by BioMarCare's parent company, Hadasit Bio-Holdings Ltd., a portfolio of biotech firms based on intellectual property, developed and owned by Hadassah University Hospital, considered Israel's foremost medical research center.
New York-based BioMarCare and Rockville, Md.-based Ariadne will jointly develop a diagnostic test, based on a panel of protein biomarkers, to direct the personal care of patients with metastatic stage colorectal cancer. Current treatments for metastatic colorectal cancer are ineffective for a significant percentage of patients, Hadasit reports. The new test would enable physicians to detect the non-responders prior to treatment, thus saving patients from unnecessary treatment.
This method would allow for a more effective course of treatment to be administered at an earlier stage of the disease, and also predict which patients would not respond to treatment before it is administered, according to Hadasit. This places the biotechs in line with the more fashionable medical trend toward more 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 percent diagnosed with metastatic stage cancer. One reason colorectal cancer is so deadly is because many patients do not want to face undergoing unpleasant imaging tests to potentially diagnose colorectal cancer, such as a colonoscopy or sigmoidoscopy.
"There are no biomarker-based blood tests approved today for early detection of disease onset, prognosis and recurrence," BioMarCare's website states. "Instead, imaging modalities are used for follow-up no sooner than 12 weeks after therapy and expose the patient to radiation."
According to the American Cancer Society, colorectal cancer is one of the 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 for the development of biomarker-based companion diagnostics, BioMarCare reports. Until superior therapeutic treatments are developed to prevent, treat and cure cancer, the best means of reducing mortality and morbidity in a disease this complex is early detection and diagnosis. In the major solid cancers, long-term survival rates drop precipitously once metastasis has occurred.
Although BioMarCare CEO Dana Cohen could not be reached for comment on this story, Cohen stated in a news release, "The prestigious BIRD Foundation's grant enables the company to develop a diagnostic product which will reduce ineffective treatment of patients and excessive costs to the healthcare system. Product development with Ariadne Inc. will also extend the company's reach to the U.S. market and may be the basis for developing additional tests to guide treatment of cancer in the future."
If successful, the joint collaboration would have many global market opportunities, according to BioMarCare. In 2007, approximately 12 million new cancer cases were diagnosed worldwide, and this number is expected to reach more than 17 million by 2020, the company reports. Cancer testing is one of the most important growth opportunities for the next three to five years. It is expected to reach a compound annual growth rate of 18 percent.
The global market for biomarkers was $5.6 billion in 2007. Biomarkers are pushing the world market for in-vitro diagnostic tests toward $12 billion by 2012. Also in 2007, the cancer biomarker market accounted for approximately 55 percent of total biomarker revenues at more than $3 billion, with the majority of revenues derived from biomarker discovery and molecular diagnostics.
The pharma industry is becoming increasingly interested in developing tests that can be used to guide the prescription of cancer therapies, and the U.S. Food and Drug Administration (FDA) has called for more and better biomarkers to accompany clinical studies.
In addition, BioMarCare is also in the process of developing diagnostic tools for colon cancer and breast cancer that are based on a simple blood test, the company reports. These tests utilize proprietary biomarkers, licensed from the Hadassah Medical Organization's technology transfer company Hadasit, and have shown high sensitivity even at early stages of the disease.
The BIRD grant is one of nine grants approved for Israeli-American collaborations in 2011, and is granted to Israeli and American collaborations in various fields, not only medical, according to a company news release. The grant will be matched by company funds and will be repaid through royalty payments from the developed product. BioMarCare and Ariadne are in the throes of finalizing their collaboration agreement and will then finalize an agreement with the BIRD Foundation, as required by the fund.