Monthly Archives: June 2016

DRAWING BATTLE LINES OVER LAB TESTS

A year after the FDA proposed regulating “high-risk” laboratory-developed tests (LDTs) along the lines of Class III medical devices, through draft guidances friendlier to for-profit diagnostic developers than nonprofit academic medical centers, both sides have advanced detailed regulatory counterproposals in hopes of swaying the agency. The Association for Molecular Pathology (AMP), whose membership includes academic…
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A SINGLE BLOOD TEST FOR ALL CANCERS?

What if a simple blood test could detect any cancer early, when it was still easy to treat? It sounds like science fiction. But Illumina ILMN +5.20%, the $24 billion (market cap) biotechnology company that has pioneered cheap, efficient sequencing of DNA, says it could be a reality in a few years. It is launching…
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