Arnon Chait thinks his company has a cheaper and more accurate technology for diagnosing prostate cancer than the much-maligned PSA test.
The Cleveland-based molecular diagnostics company, AnalizaDx, may soon get the opportunity to demonstrate just that. AnalizaDx is looking to partner with another, larger diagnostics company to help it commercialize its technology for prostate cancer and fund research into applying the test to other types of cancer.
“A successful introduction of this test should further validate its core technology, and support further development of tests for ovarian and breast cancers,” said Chait, the company’s CEO.
Chait said he’s confident the company will strike a partnership deal sometime in 2011. Rather than sell the test to customers for use in their own labs, AnalizaDx and its partner will obtain samples from clients and perform the tests themselves in a CLIA setting. Selling the test to others would require AnalizaDx to get 510(k) clearance or a Premarket Approval from the U.S. Food and Drug Administration, and avoiding that regulatory hurdle early in the commercialization process will save the company time and money, Chait said.
AnalizaDx has another big advantage: a parent company to subsidize its operations. Analiza (without the Dx) is a contract research organization (CRO) that was founded in 1997 to help drug companies with product development. AnalizaDx was spun off in 2006, with the help of a $300,000 investment from Cleveland-based economic development group JumpStart Inc. Overall, AnalizaDx has raised a dollar amount “in the low seven figures,” Chait said.
The key difference in AnalizaDx’s technology is that it measures changes to the structures of certain proteins found in the blood, called biomarkers. That means the company’s technology has the potential to be far more accurate than other tests that measure only protein amounts, Chait said.
Contrast AnalizaDx’s test with the controversial prostate-specific antigen (PSA) test, which is widely used to screen men for the cancer. While it’s normal for men’s blood to contain low levels of PSA, a high level can indicate the presence of prostate cancer. And that’s where the trouble with the PSA begins — its high rate of false positives.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“Only 25 to 35 percent of men who have a biopsy due to an elevated PSA level actually have prostate cancer,” according to the National Cancer Institute (NCI). False positives can create anxiety for patients and lead to additional medical procedures that can be expensive and risky, the NCI said.
Clinical data indicates that AnalizaDx’s test performs more accurately than the PSA, Chait said. Aside from the weaknesses of the PSA, Chait said two other factors have combined to make the present a great time for AnalizaDx’s tests. First is the national emphasis on cost containment after years of rapidly rising health costs. Second, is the rising popularity and visibility of personalized medicine and molecular diagnostics.
The worldwide molecular diagnostics market, worth $9 billion in 2009, is estimated to expand to $42.5 billion in 2019, according to Genetic Engineering and Biotechnology News.
“Diagnostics was always the lowest on the totem pole, but this field is completely and rapidly changing,” Chait said.
