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how we apply therapies and treatment,” Straley says. “Our ability to be more specific with prognostic information that is actionable [represent] the changes that the diagnostics market is looking for.”
To nail down this actionable data, scientists have had to dig deeper into the genomes of cancer to understand the specific functions and pathways that drive the disease. Such research takes us way beyond genetic tests of the mail-order variety that tell us whether we are likely to develop a disease—and stuff like where we might have cousins in Ireland—without showing us the nature of the illness or narrowing down how best to fight it. It’s sort of like the difference between being able to say that there might be termites in your home in the future, and actually being able to pinpoint where in your weight-bearing walls the bugs are eating so you can terminate them before the house collapses.
DePinho and his colleagues studied the roles of specific genes—including cyclin D1, SPP1, PTEN, and SMAD4—in both mouse models of prostate cancer and tissue samples from human patients with the disease, finding that the four genes were predictors of lethal tumors that are hardwired to spread to other organs in the body, according to Metamark. The research showed that all the cancerous mice whose SMAD4 genes were deleted developed lethal prostate tumors, according to an abstract of the paper. Straley says Metamark’s diagnostic product will be informed by the findings reported by DePinho and colleagues, but that Metamark scientists have developed proprietary methods and identified additional genes that may be used in addition to or as an alternative to the exact genes described in the Nature paper.
Prostate cancer is a large market for Metamark. In the U.S. alone there are more than 217,000 men who are diagnosed with prostate cancer every year and more than 32,000 men who die from it annually, making it the second-most lethal tumor type among American males after lung cancer, according to the American Cancer Society. The treatments for the disease can rob some men of their ability to control their bladders and to reproduce, among other painful side effects. That Metamark’s test might be able to weed out those men whose prostate cancers don’t require aggressive treatment. It might save patients lots of pain and tens of thousands of dollars in unnecessary treatments.
Still, the company has a lot of work to do before its test enters the mainstream of prostate cancer diagnostics such as checking the blood for prostate-specific antigen (PSA) levels and digital rectal exams. This year the firm plans to do retrospective study of its test using previously collected tissue samples of men with prostate cancer. Even if the company garners FDA marketing clearance and releases the test as planned next year, Straley says that there will be subsequent validation studies that will be needed to gain wider acceptance of the test among physicians and insurers.
Metamark wants to be the test of choice for the pre-treatment or prognostic segment of the market, meaning it would be used to help doctors decide the best treatment option. Yet the firm has some competition from Redwood City, CA-based cancer diagnostics firm Genomic Health (NASDAQ:GHDX), which says it is conducting a 400-patient study that is looking at over 700 genes that could help steer the course of treatment for men who are newly diagnosed with prostate cancer. Other notable players in the diagnostics are attacking the market from different angles. Salt Lake City-based Myriad Genetics (NASDAQ:MYGN), for example, has a test 46-gene test that is used after men have their prostate tumors surgically removed to tell whether they are at risk of recurrence.
“There are a number of companies out there,” Straley says. “We’re trying to be very specific about what we at Metamark are trying to solve in the marketplace, and it comes back to pre-treatment and helping the physician make a more informed treatment decision.”