Armune Bioscience Develops First Cancer-Specific Prostate Test

Armune Bioscience, the Kalamazoo-based cancer diagnostic startup, has developed what it calls “the world’s only tumor-specific, non-PSA blood test designed to help doctors detect prostate cancer.” Called Apifiny, the test is now available nationally as the company works to get the word out to clinicians that it believes it has developed a better way to discover the presence of prostate cancer.

“When a patient shows elevated PSA levels, they get referred to a urologist for a biopsy,” said David Esposito, Armune’s president and CEO, referring to the current industry-standard test to detect prostate cancer. (PSA refers Prostate-Specific Antigen, a protein naturally produced by the prostate gland that typically increases when cancer is present.) “That drives a lot of unnecessary procedures because the test is not cancer-specific. If it indicates something abnormal, it could be a number of conditions besides cancer.”

Armune’s Apifiny (pronounced like “epiphany”) test measures the body’s immune response and autoantibody levels to figure out if it’s fighting prostate cancer. Using an algorithm, Apifiny takes a patient’s “scores” from the test and rolls them into one number between zero and 100 to determine if they have high or low risk for developing cancer.

“The higher the score, the higher the risk,” Esposito said. “If I have a score of 45 and the test is predicting a lower risk, it’s accurate nine out of 10 times—and that’s very accurate for a diagnostic test. Apifiny can enable doctors to identify lower-risk patients and put them on a more relaxed monitoring program.”

Armune was formed in by members of the Apjohn Group in 2008. It licensed a library of autoantibody “signals” from the University of Michigan that can be used to test the body’s immune response to prostate, lung, and breast cancer. In January, Armune closed the first investment in its $2.5 million Series A funding round, which it’s seeking in order to propel Apifiny widely to market. Esposito said the company has raised $1 million so far from “company insiders and angel investors.”

After it raises the Series A round, Esposito said Armune will soon start on a Series B round worth $10 million to $12 million to enable it to grow further and expand testing to detect breast and lung cancer. Armune has also gotten financial support from the Michigan Economic Development Corporation and by winning the $500,000 grand prize at the Accelerate Michigan business competition in 2010. In total, Armune has raised $7 million in grants and loans since 2008, Esposito said.

The path to commercialization Armune is taking involves developing Apifiny as a standard lab test, in which the company sends blood draw kits to doctors, and doctors FedEx the sample back to the newly opened Armune lab in Ann Arbor for analysis. Armune began selling the Apifiny test commercially in April, and last week released data showing that its finger-prick blood test produces results that are as accurate as those from standard venous punctures. The Michigan Institute of Urology is the first clinic in the nation to sell the test.

Esposito said he welcomes the chance to prove to doctors and patients that early detection, often critical to surviving cancer, doesn’t have to be invasive to be successful; he hopes to make Apifiny a “household name” in the next few years.

“The immune response is detected five years before nodules form in the prostate, and I think breast cancer is the same,” he added. “Let’s use this test to measure immune response before we take drastic action like a double mastectomy.”

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