A Gary-based biotech company has announced a strategic partnership designed to accelerate the timeline toward FDA approval for its breast cancer testing technology. IVDiagnostics says the deal with Pennsylvania-based Prevail Partners Inc. will provide high-quality data from clinical studies at a more rapid pace.
IVDiagnostics is seeking Phase 1 FDA approval for Velox, a diagnostic cancer test which tags and monitors circulating tumor cells in a cancer patient’s body. The company says the test will provide more accurate and frequent monitoring of a patient’s progress during and after treatment.
The company says current imaging systems can only detect solid tumors of 1 millimeter or greater in size. The Velox test would be able to capture individual cancer cells within 2-30 microns in size. IV Diagnostics adds the test would ideally be used for patients with advanced stage cancers.
Prevail Partners, a subsidiary of Prevail InfoWorks Inc., will also invest an undisclosed amount money in IVDiagnostics in addition to assisting with the clinical studies.
"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," said Mary Schaheen, president of Prevail Partners. "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."
IVDiagnostics Chief Executive Officer Frank Szczepanski says the partnership is "precisely what we need" to achieve FDA approval for Velox. You can learn more about the test by clicking here.