Gary biotech company developing breast cancer testing

The science labs for use primarily by Ivy Tech students are the newest and most up to date in the country. A biotech company based at Ivy Tech Gary is pursuing FDA approval for a breast cancer testing method.

Tony V. Martin, The Times

A biotech company in Gary lined up funding from a Philadelphia-based life sciences investment fund to develop a new breast cancer testing technology.

IVDiagnostics, which operates on the Ivy Tech Gary Campus, is seeking Phase 1 U.S. Food and Drug Administration approval for Velox, a new testing method which tags and monitors circulating tumor cells in the body. The company describes its test as "revolutionary," saying it can capture individual cancer cells that are within 2-30 microns while current imaging systems can only detect solid tumors of 1mm or more in size.

"The Velox diagnostic cancer test tags and monitors circulating tumor cells in a cancer patient’s body allowing doctors and oncologists to provide more accurate and frequent monitoring of a patient’s progress during and after treatment," IVDiagnostics said in a news release.

Prevail InfoWorks and its subsidiary Prevail Partners will help IVDiagnostics with its clinical studies and invest and undisclosed sum in the testing.

“Everyone at Prevail Partners is excited to invest in the growth of IVDiagnostics as they develop the fastest and lowest cost CTC assay for the accurate in-vitro monitoring of pathogenic cell growth in patients undergoing cancer treatment or other blood-borne diseases," Prevail Partners President Mary Schaheen said. "Furthermore, we have great confidence in our partnership and its ability to accelerate IVDiagnostics to a significant value inflection point through the completion of its planned pilot and pivotal trials.”

Northwest Indiana-based IVDiagnostics develops, tests and markets new diagnostic tools for rare circulating tumor cells and blood-borne diseases, including Velox, which it said is ideal for patients with advanced stage cancers. The company won the 2011-2012 Chanute Prize for Team Innovation and an eDay award from the Northwest Indiana Small Business Development Center for its cancer research.

The company is pursuing FDA approval – a lengthy process that requires extensively testing – for its latest innovation so it can bring it to the market.

"This partnership with the leading FDA approved analytics driven process and data management company is precisely what we need to succeed with the FDA approval of our initial breast cancer assay," IVDiagnostics President and CEO Frank Szczepanski said.

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Business reporter

Joseph S. Pete is a Lisagor Award-winning business reporter who covers steel, industry, unions, the ports, retail, banking and more. The Indiana University grad has been with The Times since 2013 and blogs about craft beer, culture and the military.