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FDA submission

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – Pathway Genomics today said that the US Food and Drug Administration has classified and registered its saliva collection kit as a Class I exempt device.

The firm completed a submission to FDA for use of the test as a companion to Erbitux, a monoclonal antibody EGFR inhibitor with sales last year of $820 million.

A company official shed little light on Agilent's plans for the diagnostics space, but an investment analyst said that the company will probably remain a peripheral player.

The firms intend to file the software with the US Food and Drug Administration for molecular diagnostic applications.

Nanosphere said that it believes the deficiencies cited in the letter from the FDA are resolvable, and it believes that the test will ultimately gain clearance from the agency.

CFO Roger Moody talked up Nanosphere's test for Plavix metabolism and other tests in the company's pipeline at the Jefferies Global Healthcare Conference.

The House Oversight Committee heard about how FDA's devices process may be slowing down the medical devices industry.

The test is being used in clinical trials with Pfizer's crizotinib, an anaplastic lymphoma kinase inhibitor.

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Researchers tie a variant in ADAMTS3 to breathing difficulties in dissimilar dog breeds, according to Discover's D-brief blog.

The Japan Times reports that researchers sequenced the genome of a woman who lived during the Jomon period.

Parents of children with rare genetic disease have to contend with shifts in the interpretation of genetic variants, the Wall Street Journal reports.

In Science this week: single-nucleus RNA sequencing of brain tissue from individuals with autism, and more.