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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.

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Nature News examines how science in the UK may fare as Boris Johnson, the next prime minister, pursues Brexit.

CNN reports that Immigration and Customs Enforcement in the US has expanded its DNA testing to seven sites along the southern border.

In PNAS this week: role for exosomes in neuronal circuit development, tuberculosis pathogen enzymes, and more.

Undoing Obamacare protections could affect people's willingness to undergo genetic testing, Sarah Lawrence College's Laura Hercher and the University of Iowa College of Law's Anya Prince write at BuzzFeed News.