Six Sigma Can Help Monitor New CLIA Proficiency Testing Changes
A PT update went into effect on January 1, focusing on revised acceptance limits, among other modifications
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ProPhase Labs’ Resolution for 2025: Nail Down a ‘Liquidity Event’
The company has lost nearly $36 million since 2023, but its CEO is aggressively pursuing new revenue options
Compliance Concerns: Laboratory Regulations in 2024 and Beyond
Earle S. Collum, chair of the CAP Council on Accreditation, talks through regulatory changes in 2024 and what to expect from 2025
Despite MDUFA Setback, VALID Act Is Back on Track for Passage
Though Congress didn’t pass VALID as part of the medical devices user fees bill, there’s still a good chance it will pass before year’s end.
Holmes May Get a New Trial on Basis of Witness Tampering
Sentencing has been postponed for one month to explore possible government mishandling of key witness testimony.
HHS’ Proposed New Anti-Discrimination Rule & What You Can Do to Comply with It
What you need to know about the 308-page proposed rule and its potential impact on your lab, along with a basic strategy to implement it.
Ambry Genetics Shells Out Millions to Settle Data Breach Class Action
The problems began in January 2020 when hackers got access to an employee’s email account, compromising clients’ personal data.
FDA Tightens the Screws on EUA Review of COVID-19 Tests
The agency recently announced subtle but significant changes to its policies governing review of new lab tests for COVID-19.
M&A Report: Biosynex Looks to Snag Theradiag
A roundup of key mergers, acquisitions, and strategic asset purchases in the healthcare industry in September.
Qiagen Moves into Neurology with Recent Collaboration
The Hilden, Germany-based company is extending its genetic testing profile beyond oncology to neurology biomarkers.
FDA Sets New Limits on EUA Requests for COVID-19 Tests
The agency recently stated that current testing capacity is adequate and established limits on its review of new EUA submissions.
Inadequate Reimbursement Threatens Monkeypox Lab Testing Response
ACLA and public health experts warn that current reimbursement rates will hamper US efforts to contain monkeypox spread.
LDTs: Congress Set to Scuttle VALID Act at the Eleventh Hour
Congress reportedly set to pass a stripped-down version of the FDA user fees bill without the VALID Act component regulating LDTs.
