NEW YORK (GenomeWeb) – UK-based Population Genetics Technologies, which is developing infectious disease diagnostics, is opening up offices in Cleveland as it readies its HIV drug resistance and tropism test for launch in 2016 as a US Food and Drug Administration 510(k)-cleared and CE-marked product.

The HIV test is the first of several next-generation sequencing-based infectious disease tests the company plans to develop, with a hepatitis C virus test following close behind, PGT CEO Alan Schafer told GenomeWeb.

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At his FDA Law Blog, Jeffrey Gibbs discusses FDA's technical assistance for the draft Diagnostic Accuracy and Innovation Act.

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