How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
Essential
Subscribe today for access to
Articles and Reports
FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
The Year in Lab Compliance: The 6 Biggest Stories of 2022
The year was certainly an interesting one in terms of regulatory change in the medical laboratory space.
Q3 Lab Company Earnings Take a Hit
A decline in COVID-19 testing demand, along with a challenging economy, made for a difficult quarter for diagnostics companies.
Amazon Makes Third Attempt to Disrupt Healthcare Business
Having twice failed to disrupt health care, Amazon opts for a different strategy this time around—and it may just work.
December 2022 FDA Watch: More Approvals in US than EU
A high volume of FDA approvals for new tests and diagnostic products made up for the relatively low number of approvals in the EU.
How to Use Mobile Apps to Optimize T&E System Performance in Labs
Automating travel and expense significantly improves performance, but adding mobility takes such improvements to a much higher level.
A Brief Look at the COVID-19 Saliva Testing Global Market
The recent FDA approval of an OTC test shows that COVID-19 saliva testing may be poised for bigger and better things in the years ahead.
Strategic Deals in DX Space Remain Low in Number, but High in Impact
Though only seven transactions were announced or closed in November, two were billion-dollar deals.
December 2022 Labs in Court: FCA and a Sex Discrimination Case Dismissed
Key cases over the past month were the usual FCA-related fare, apart from a dismissed sex discrimination case.
Compliance Tool: Model Policy on Telecommuting & Remote Work
It’s important to have a clear policy in place for approving remote work requests and ensuring employees remain productive.
December 2022 Enforcement Scorecard: Unusual Suspects
Federal enforcement actions at the end of October and first two weeks of November featured some unusual characters.
