Clinical trials for Sensigen diagnostics planned, staff could double
A diagnostic test for HPV that is “light years ahead” of others will undergo clinical testing and could mean a doubling of staff for Sensigen.
Ann Arbor-based Sensigen develops diagnostic kits that are much more sensitive and accurate than what is currently on the market. One of the tests, which screens for HPV, is currently being evaluated by one of the largest commercial laboratories in the states and will head into clinical trials later this year on its way to FDA approval.
The test, which uses the same biological sample taken for a PAP test, can determine not only whether a woman is infected with HPV, but what strain of the virus she is carrying at what level – and whether or not the strain is one that can lead to cervical cancer. The test also can tell a woman if she is a candidate for the HPV vaccine. “Ours is the only test that can tell you whether you are a candidate,” explains CEO Shawn Marcell. “The vaccine doesn’t work if you have previous exposure to two particular strains. Our test is a light year ahead of what’s out there today.”
The platform for the diagnostic test was invented by Dr. David Kurnit at the University of Michigan. Sensigen formed to license the test from UM. Funds were raised, principally from Michigan Economic Development Corporation, which allowed the start-up to bring Marcell on board. Marcell is Philadelphia-based, along with two other Sensigen employees, while research and development is headquartered in Ann Arbor. He anticipates the Ann Arbor staff of five will double by the end of the year.
Marcell estimates FDA approval on the HPV test will take about two years and meanwhile, the company has several other tests in the pipeline, including ones for kidneys, lupus and inflammatory bowel disease. He explains that the basic premise of their test is “a very flexible platform.”
Marcell is happy with their Ann Arbor base of operations. “What’s not to like about Ann Arbor?” he asks. “There’s a great university, wonderful people, a friendly business climate and it’s not as pricey as the east or west coasts.”
Marcell is focused on raising venture capital. He says they are receiving attention from funds outside of Michigan, and calls for a “more robust” VC community in Michigan.
Source: Shawn Marcell, Sensigen
Writer: Kelli B. Kavanaugh
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