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FDA Synthesizes Feedback on LDTs in New Discussion Paper
From - National Intelligence Report
Following up its decision not to issue final guidance in 2016 regarding oversight of laboratory developed tests (LDTs), the U.S. Food and Drug Administration released a…
First HIPAA Breach Notification Settlement Totals $475,000
From - G2 Compliance Advisor
Patient health information breaches—whether from hacking, glitches or just plain old carelessness…
Sequencing Following Ultrasound Improves Prenatal Diagnosis
From - Diagnostic Testing & Emerging Technologies
Nonsevere fetal malformations and structural abnormalities are relatively frequent findings of routine, prenatal ultrasounds. Yet, these findings provide…
FDA Approves Next-Gen Companion Diagnostic
From - Laboratory Industry Report
A notable FDA Section 510(k) approval was granted before the close of 2016 for Foundation Medicine's FoundationFocus CDxBRCA, a next-generation sequencing-based companion diagnostic test…
Update on Palmetto’s Molecular Dx Testing LCDs
From - Diagnostic Testing & Emerging Technologies
Advanced diagnostic tests are emerging faster than the clinicians can document their clinical utility. All of this creates an interesting dilemma for…
Diagnostics to Play Important Role in Food Allergy Safety
From - Diagnostic Testing & Emerging Technologies
Despite the commonly held belief that the food allergy prevalence is rising, food allergies remain poorly studied and…
OIG Updates Threshold for Nominal Value Gifts
From - National Intelligence Report
Just as the civil monetary penalties have gotten an update to adjust for inflation so too have the thresholds for…
OIG Targets Sleep Study Tests
From - G2 Compliance Advisor
If your lab performs sleep studies on Medicare patients, beware. It is now a high-priority target for federal fraud and…
Molecular Diagnostics among Top 2016 M&A Deals
From - Laboratory Industry Report
Although volume of diagnostics industry mergers and acquisitions was up slightly in 2016, the big story of the year were the deals that…
DOJ Surveys False Claims Victories for 2016
From - National Intelligence Report
As we closed out the calendar year, the U.S. Department of Justice (DOJ) reflected on its successes for the fiscal year 2016 (FY 2016) which ended…