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Medical diagnostics startup opens lab for first product

April 29, 2015
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Medical diagnostics startup opens lab for first product
Armune BioScience Lab Director Jeanne Ohrnberger prepares samples for processing at the medical diagnostic startup's Ann Arbor laboratory. Courtesy Armune BioScience

A venture capital-backed medical diagnostics startup has opened a lab to roll out its test to help clinicians detect prostate cancer in patients.

Armune BioScience in Kalamazoo said this month that it has opened a Clinical Laboratory Improvement Amendments, or CLIA, laboratory in Ann Arbor, at 401 West Morgan Rd., to offer laboratory services for its first product, Apifiny.

Armune BioScience says Apifiny is the only tumor specific and non-prostate-specific antigen, or PSA, blood test for prostate cancer.

Lab services

The roughly 1,500-square-foot laboratory offers testing kits of Apifiny to offices and reference laboratories, conducts the laboratory testing and provides the results to referring clinicians.

David Esposito, president and CEO of Armune BioScience, said the company has begun selling Apifiny via the lab.

Esposito said the prostate cancer test is "really a game changer in terms of physicians and patients wanting and needing access to a very simple blood-based test that could give insight to how the immune system responds to prostate cancer." 

“There are other tests out there, but not a lot of them are blood based and without PSA," Esposito said. "There are not a lot of diagnostic tools available.”

The CLIA-registered lab has three staff members, and Armune anticipates hiring a few additional medical technologists.

Providers

The company also said this month that the Michigan Institute of Urology, or MIU, is its first customer and the first urology group in the country to offer Apifiny.

Dr. Jason Hafron, a urologist with MIU, said as an organization that uses new diagnostic tools to improve patient care, the institute looks forward to being the first group of physicians in the country to offer Apifiny to patients.

“We continue to look for tools to help minimize the number of prostate biopsies, and we look forward to the potential insight that Apifiny can bring to our decision making,” Hafron said. “The problem is higher levels of PSA can also be caused by a benign enlargement or inflammation of the prostate, leading to many false-positives for cancer and ultimately unnecessary invasive biopsies and an increased potential for patient harm.”

With the official release of Armune BioScience's cancer test product, Esposito said there are roughly 55 urologists on the east side of the state and a few clinicians in West Michigan who have begun using the test.

Road to commercialization 

The technology and research behind Apifiny was developed under the direction of Dr. Arul Chinnaiyan at the University of Michigan.

Armune BioScience was established in 2008 when the technology was licensed from U-M to work on commercializing the technology into a laboratory test.

“The company then moved the work into a laboratory to see if they could commercialize the technology . . . to try to industrialize a basic blood test that captures and measures that auto antibody in a human’s blood,” Esposito said. “We received some initial funding and took it as far as we could. We were running low on money to commercialize the test and last year developed a plan to raise additional funds.”

Armune BioScience launched a $2.5 million Series A Financing round to raise additional funding to support the opening of the laboratory and bring the product to market. The company announced a first close of the Series A round this January and has raised about $1 million of the $2.5 million.

“We are still raising additional funds to close out that $2.5 million,” Esposito said. “In Grand Rapids, the Grand Angels have been supporters of the business early on.”

Armune BioScience

Armune BioScience was founded by the Apjohn Group, a business accelerator of experienced health care executives.

The early stage medical diagnostics company develops and commercializes diagnostic tools for prostate, lung and breast cancers.

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