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Abbott Scores First FDA Greenlight for Commercial Use of Monkeypox Test
Abbott’s Alinity m MPXV assay for detecting DNA from the monkeypox virus received FDA EUA on Oct. 7.
New Legislation Could Make MA Prior Authorization Process Less Tedious
For labs and other healthcare providers, a bill now before the Senate could mean a less labor-intensive prior authorization process.
Lab Institute Who’s Who: Joyce Gresko
Learn more about how Congress could change PAMA, why it matters to your lab, and how you can prepare.
How COVID-19 Transformed Healthcare Delivery
The pandemic came with great pain and suffering for many, but it also allowed telehealth and other technologies to flourish.
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.
Lab Institute Who’s Who: John (JD) Donnelly
Learn more about how leveraging data automation to get clean patient data at the front end can be a game changer for labs.