New FDA Guidance Aims to Ease Approval for New NGS Tests–But It Probably Won't Work

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May 15, 2018

FOCUS ON
New FDA Guidance Aims to Ease Approval for New NGS Tests–But It Probably Won't Work
From - National Intelligence Report
Test makers have long complained about the FDA's unwillingness to embrace technology and diagnostics advances. But on April 13, the agency took steps to address…
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		EMERGING TESTS Genetic Risk Score Could Improve Diagnosis of Atrial Fibrillation From - Diagnostic Testing & Emerging Technologies A genetic risk score (GRS) may identify patients at highest risk for developing atrial fibrillation (AF), according to a study published… Read More

		NEW PRODUCTS The Dx Pipeline: A Roundup of the Month's Key New Product Launches From - Laboratory Industry Report Fluidigm, Qiagen and MNG Laboratories launched multiple products. Here's a rundown of the key diagnostic product launches from late March through mid-April… Read More

FALSE CLAIMS
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Case: The feds accused a Missouri lab of submitting false claims to Medicare for travel fees in transporting specimens from April 2011 to December 2014. In addition…
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