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Independent Dx Certification Startup USDS Raises $1.5M

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – A start-up company led by a former Critical Path Institute official has received $1.5 million in private equity funding, according to a filing with the Securities and Exchange Commission.

The company, United States Diagnostics Standards, or USDS Inc., was founded by Jeffrey Cossman, who served as chief scientific officer of C-Path and directed the public-private consortium's Washington, DC-area office.

USDS was launched as an independent certification body for laboratory and pathology diagnostics and aims to help diagnostic developers verify the analytical and clinical performance of their tests before they are submitted to the FDA for approval.

As reported in GenomeWeb Daily News sister publication Pharmacogenomics Reporter last year, Cossman was initially working with C-Path to develop a non-profit organization also called United States Diagnostics Standards that would provide test evaluation services to companies but would not have any enforcement power.

“We want to look at ways to improve the efficiency of the requirement for the highest standard of approval at FDA, which is the [pre-market approval], and how companies can improve their efficiency in getting to that very high bar,” Cossman said of the USDS proposal in 2009, as reported in PGx Reporter.

It's unclear whether the launch of the for-profit USDS Inc. means that the non-profit effort has been abandoned. Cossman was not immediately available for comment.

In addition to his role at C-Path, Cossman was a co-founder of Halcyon Diagnostics and Avalon Pharmaceuticals, and was a founding adviser for Ventana Medical Systems and a co-founder of the Association for Molecular Pathology. He also was VP and medical director at GeneLogic.

According to the SEC filing, Maryellen De Mars, who was director of genomics services at Gene Logic and director of the biorepository at C-Path, is also involved in the new venture.

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