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CellMax Life, Sebela Pharmaceuticals Sign Commercial Agreement for Colorectal Cancer Dx Test

NEW YORK – CellMax Life and Sebela Pharmaceuticals said on Tuesday that they have signed a strategic development and agreement to complete commercial development of CellMax's FirstSight liquid biopsy assay.

Sunnyvale, California-based CellMax also completed a Series C financing for an undisclosed amount to speed up development of its test to detect colorectal cancer and precancer polyps. The financing round included participation from new investor Aflac Ventures and existing investor ArtimanVentures.

To detect pre-cancer and cancer cells in a blood sample, the FirstSight assay uses a microfluidic chip with a non-sticky nanolayer, high-affinity antibodies, and an air-foam technology to capture and subsequently release cells. The method allows for the preservation of intact cells and enables the detection of pre-cancer.

Roswell, California-based Sebela plans to seek 510(k) approval for the assay from the US Food and Drug Administration and will commercialize the test in the US.

"For the last several years, we have closely followed the industry's development of colorectal cancer liquid biopsies," Alan Cooke, CEO of Sebela Pharmaceuticals, said in a statement. "FirstSight may not only enable the US to exceed 80 percent screening rate target … but can also help detect pre-cancerous adenomas early, referring patients to colonoscopy for preemptive removal."

Researchers at Stanford University Medical Center and the Veteran Affairs Palo Alto Health Care System presented data from a prospective study last May on FirstSight's ability to screen for CRC in patient samples.