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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
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.
CMS Sheds New Light on Proper Use of Modifier 59
Due to the common misuse of this modifier, the Centers for Medicare & Medicaid Services recently issued important new guidance on its proper use.
False Billing of Lab Tests and Two Dismissed Lawsuits
This month’s key lab cases involve false billing of urine drug and PGx tests and two lawsuits that were tossed.
