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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
HIV Testing Saw Big Declines in Pandemic’s First Year, New Data Show
Recently released CDC data show that the largest drops occurred among groups who are most affected by HIV.
AACC to Host Discussion with Theranos Whistleblowers
Hosted by AACC president Dr. Stephen R. Master, the talk will cover the ethics of lab testing and the role of clinical lab professionals.
HHS Scrambles to Deal with Aftermath of Roe v. Wade Revocation
Now that the Supreme Court has revoked Roe v. Wade, HHS must rework policies, programs, and procedures related to reproductive rights.
Congressional Bill Offers Labs PAMA Pricing Relief
Legislation introduced last week would require the use of a more reliable representative sample to determine lab test reimbursement rates.
COVID-19 Test Profits Make Labs Potential Target for Public Backlash
Independent labs accrued a profit of at least $10 on each PCR COVID-19 test performed in the period from May to December 2020, study says.
Becton Dickinson, Cepheid Unveil Monkeypox PCR Test Collaborations
Some of the lab industry’s biggest players are teaming up to develop new monkeypox diagnostics in response to the current outbreak.
DOJ Enforcers Turn Up Heat on Healthcare Private Equity Fund Deals
A hostile government policy has done little to slow consolidation of independent medical practices and hospitals.
Bill to Regulate LDTs Advances, but Is No Slam Dunk for Final Passage
Now that the finishing touches have been put on LDT-related legislation, what is the likelihood that it will pass?
Three New Monkeypox Testing Solutions Launched
Two PCR assays and a PCR point-of-care solution from three different companies aim to help with diagnosing cases, tracking new variants.
Liquid Biopsy Can Rule Out Post-Surgery Chemotherapy for Colon Cancer
A post-surgery liquid biopsy test capable of detecting ctDNA could eliminate the need for chemotherapy for some stage II cancer patients.
