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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
US Government Launches Nationwide Test-to-Treat Initiative
Recently unveiled program aims to ensure easy access to COVID-19 treatments for all eligible Americans.
Physicians Get a Break on 2021 MIPS Payment Adjustments
Just as it seemed like physician practice patterns were getting back to normal, the late-year Omicron surge skewed the Merit-based Incentive Payment System (MIPS) quality data for 2021. With that in mind, the Centers for Medicare & Medicaid Services (CMS) has...
Potential New Test Could Diagnose Lyme Disease Sooner
For scientists and clinicians alike, one of the Holy Grails for successfully treating and curing Lyme disease is developing tests that identify the disease sooner, show when people are cured of infection, and can diagnose reinfection. Now, researchers at Tufts...
FDA and Industry Reach Agreement on MDUFA V Medical Device User Fees
For a while, it looked like the FDA and medical tech industry might not cut a deal on the next round of medical device user fees under the Medical Device User Fee Amendments (MDUFA V) before the current agreement expires in September. But last week, the agency...
Singleron Extends Reach outside of China with Acquisition of Proteona
Last week, Chinese genomics company Singleron Biotechnologies, which develops single-cell multi-omics platform technologies and helps translate them to the clinic, announced it had acquired Proteona Pte. Ltd. Based in Singapore, Proteona is also focused on the...
Home-Based Flu Tests as Accurate as Rapid In-Clinic Options
Home-based, self-administered tests for influenza are comparable in accuracy to rapid diagnostic tests in clinical settings, according to a recently published, peer-reviewed study. “Home tests are a valuable tool to support the management of influenza and other...
New Act Would Mean Wider Medicare Coverage of Genetic Cancer Screening
Legislation would require Medicare to cover genomic cancer testing and follow-up screening for those with a family history of cancer.
ONC Seeking Public Input on Electronic Prior Authorization Standards
The ONC requested input on certification standards for the development and implementation of electronic prior authorization IT products.
Website Ad Doesn’t Bar Qui Tam Suit for Rewards Program Fraud
A new case from the US Court of Appeals for the Ninth Circuit tests how far the public disclosure bar goes.