Useful Links
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…
G2 Blog
Outreach Survey Focuses on Clinical Laboratory Industry Trends Amidst Greatest Disruption in Three Decades
By Jeff Myers bio
Accumen Inc. is pleased to announce the launch of the 17th Annual National Hospital and Health System Laboratory and Outreach Survey. The survey is designed to capture intelligence on…
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…
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…
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…
Profound Discrepancies Seen Between DTC Genetic Results, Confirmatory Testing
From – Diagnostic Testing & Emerging Technologies
Raw data from direct-to-consumer (DTC) genetic tests have an “alarmingly high” false-positive rate, according to a study published…