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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
Senate Renews Efforts to Reform LCD Processes
From - National Intelligence Report
Efforts to improve the local coverage determination process have been renewed with the introduction of the Local Coverage Determination Clarification Act of 2017. The proposed bill is the result of…
Will AHCA Adversely Affect Genetic Testing?
From - National Intelligence Report
While it remains uncertain what the Senate will do with the American Health Care Act (AHCA), alarm is spreading about the legislation's implications for the estimated quarter of…
The Dx Pipeline
A roundup of the month’s key new product launches
From - Laboratory Industry Report
As usual, genome and sequencing products dominated the diagnostics pipeline last month. Exceptions included rapid diagnostic testing products from…
Biomarkers Personalize PSA Screening
From - Diagnostic Testing & Emerging Technologies
Early diagnosis of prostate cancer (PCa) is marred by a lack of consensus on the best screening strategy. Prostate specific antigen (PSA) had been…
8 Tips for Investigating Sexual Harassment
From - G2 Compliance Advisor
President Trump declared April National Sexual Assault Awareness and Prevention Month. Sexual harassment is a related problem that all employers must proactively address and…
FDA Reports Advances in Diagnostics Development
From - National Intelligence Report
The U.S. Food and Drug Administration (FDA) recently unveiled its FY 2015-2016: Regulatory Science Progress Report. The report, the second of its kind under the Food and Drug Administration Safety and Innovation Act, says the…
iSpecimen Generates New Market for Discarded Biospecimens
From - Diagnostic Testing & Emerging Technologies
iSpecimen (Lexington, Mass.) can be thought of as a cross between a dating site and an online marketplace for human biospecimens. The company has built…
Do No Harm: Diagnostic Errors and the Lab
By Jennifer (McMahon) Dawson, MHA, DLM (ASCP) bio
"Do no harm" is the mantra that health care providers live by. Doctors, nurses and laboratory professionals alike enter into the business of health care because they are motivated to…
Blood Test Could Improve CAD Diagnosis
From - Diagnostic Testing & Emerging Technologies
A simple blood test can accurately, noninvasively, and quickly diagnose heart disease, according to a study published in the…