Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Laboratory Developed Test Regulatory Reform Moves Closer to Reality
Newly proposed legislation would establish a risk-based regulatory system for LDT regulation, though not everyone is happy with it.
LabCorp Gets First FDA Greenlight for SARS-CoV-2 Differentiation Test
For the first time, the FDA has granted emergency use authorization for a test to differentiate strains of the SARS-CoV-2 virus.
Clinical Labs and Owner Charged in Alleged $2 Million UDT Scheme
Three labs, their owner, two lab marketing companies, a fourth lab, and a physician are accused of kickbacks, money laundering, and fraud.
Could AI Reduce CT Scans in Cancer Detection and Assessment?
A new AI method developed by the National Cancer Institute could produce results similar to regular CT scans, but without exposing patients to radiation.
FDA Resumes Pre-Submission Requests for Non-COVID-19 IVD Tests
Effective June 1, the agency is once more accepting pre-submission requests for all in vitro diagnostics, including non-COVID-19 tests.
New Laws Seek to Protect Healthcare Workers from Violence
With threats and attacks increasing, Congress has tabled a bill that would impose extra penalties on those seeking to harm healthcare staff.
How to Make Genetic Testing Relevant for All Groups
Researchers propose solutions to underrepresentation of certain groups in genetic databases, based on two recent initiatives.
New Guidelines Released for Pancreatic Cancer Screening
The American Society for Gastrointestinal Endoscopy releases new recommendations for screening those with genetic susceptibility.
Caris Life Sciences Settles Medicare 14-Day Rule Claims for $2.88 Million
The company was facing allegations that it had intentionally delayed submitting lab tests in order to circumvent the rule and receive payment.
Alleged Violation of Medicare’s 14-Day Rule Costs Company $2.8 Million
Caris Life Sciences agrees to pay $2.8 million to settle claims that it purposely delayed submitting lab tests to get around Medicare’s 14-day rule.
