Personalized Prognostics

By Cindy Atoji

October 28, 2008 | From heart attack to prostate cancer, a growing number of prognostic tests provide personalized information, enabling physicians to make more informed treatment decisions. “Like a GPS for cancer treatment, the Exiqon/Oncotech EDR Assay assists oncologists in determining the best course of treatment for a given patient,” says Cynthia French, chief scientific officer for the Tustin, Calif.-based biotech that offers this molecular diagnostic test to analyze the genetic profile of a tumor.

The newly merged Exiqon/Oncotech is not alone. With rapid advances in microarrays and other pioneering technologies, there has been a corresponding increase in the use and impact of these complex tests, developed by companies such as Aureon Laboratories, which recently introduced a biopsy-based test to predict—at the time of diagnosis—the likely behavior of a person’s prostate cancer, including how aggressive the tumor is and whether it will recur. “Although the majority of prostate cancer cases are detected early and categorized as lower risk, there are a significant number of men within this segment whose tumors will grow aggressively, and jeopardize their lives,” said Vijay Aggarwal, president and CEO of the New York City-based life sciences firm. “Physicians need access to better tools that will assess disease severity and identify high-risk patients hidden within these lower-risk groups.” According to Aggarwal, the company’s predictive pathology test combines biomarkers with clinical information to create a personalized report about a patient’s prostate cancer.

In the market for DNA, RNA, and protein diagnostics, which is estimated to be $2 billion and growing rapidly, Nanosphere is also positioning itself as a leader, touting their Verigene system, which “leverages nanotechnology to move genetic and protein testing to the point of care” says company executive Michael McGarrity, who believes that ultimately hospital-based labs may be able to screen fluid samples for certain types of infectious diseases, cancer, neurodegenerative, and cardiovascular diseases. A blood test, for example, has the potential to catch the very early signs of heart attack by detecting a protein called troponin I—released in the beginning stages of cardiac arrest—at a level hundreds of time less than what is detected by current tests. “Nanosphere’s biobarcode technology enables extraordinarily sensitive detection of proteins in clinical samples,” says McGarrity.  “Hospital based labs will have access to specific protein assays occurring in low abundance—these were previously able to be identified only through the use of highly sophisticated and expensive mass spectrometry systems.”

But Nanosphere’s current menu of diagnostic tests is limited, and there is still work to be done on Aureon’s predictive technology to create even more specific prostate cancer treatment guidelines. These slow-but-sure breakthrough advances in molecular diagnostics, though, promise to improve chances for rapid and successful treatment, says French of Oncotech/Exiqon. She points to their Extreme Drug Resistance (EDR) Assay lab test. “This test is the only one available that is capable of identifying extreme drug resistance in solid tumors with over 99 percent accuracy, allowing cancer patients to avoid needless chemotherapy and try the most promising treatment for them,” says French.

“This is an accurate and personalized assessment of disease severity and risk of prostate cancer recurrence,” says Aggarwal of Aureon Laboratories about their test. “For patients, that means more objective information about their specific tumor—alleviating a lot of anxiety and even possibly extending their life.”

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