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CLIA

In order to operate in New York, "Navigenics agreed to make certain concessions … by modifying the DTC portion of their business," a regulatory official from the NY Department of Health's Wardsworth Center said this week.

The company is seeking the CLIA waiver while it also pursues FDA clearance of the FilmArray and a respiratory panel designed to identify and detect 22 upper respiratory diseases.

Enzo aims to market the ColonSentry test in NY and NJ.

DTC personal genomics firms, such as 23andMe, "don't have a laboratory, but they do [genomic] interpretation," Penny Thompson, deputy director of CMS' Center for Medicaid and State Operations, said during a meeting of the HHS Secretary's Advisory Committee on Genetics, Health, and Society in Washington, DC, last week. "That doesn't fall under CLIA."

During a webinar hosted this week by Genetic Alliance, Paul Radensky, a partner in the law firm McDermott Will & Emery, discussed FDA's regulation of diagnostic tests and noted that ACLA met with FDA Commissioner Margaret Hamburg to discuss a proposal for an inter-agency approach to regulating LDTs.

To make up for the "lumpiness" of the market for genome-wide association studies, Affy will focus on applications that are downstream from GWAS, particularly in validation and routine testing, according to President and CEO Kevin King, who also shed some light on Affy's recent decision to sell its Clinical Services Laboratory to Navigenics.

Navigenics decided to acquire Affy’s 10,000-square-foot Clinical Services Lab in Sacramento, Calif., after seeing an increase in the volume of orders for its genetic screening service. In addition to the advantages of having an internal CLIA lab, however, the consumer genomics firm will now have to navigate a complex regulatory environment.

BioArray Briefs: 2009.02.24

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Google's Project Nightingale has collected health information on millions of Americans, according to the Wall Street Journal.

An opinion piece at The Hill criticizes the proposed plan to collect DNA samples from migrants at the US border.

Nature News writes that women in chemistry are less likely to have their manuscripts accepted for publication.

In PNAS this week: tRNA fragment signature for chronic lymphocytic leukemia, genomic sites sensitive to ultraviolet radiation in melanocytes, and more.