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Beckman Coulter
July 22, 2024, Intelligence: Late-Breaking Lab News
Some hospitals failing to comply with the federal price transparency regulation have been fined. The website of CMS.gov lists 15 hospitals and the amount each was fined. On June 6, 2022, the first fines were levied against Northside Hospital of Atlanta ($883,130) and Northsid…
July 1, 2024, Intelligence: Late-Breaking Lab News
Last week, it was announced that Quest Diagnostics “would acquire select laboratory assets from 12-hospital Allina Health” the Minneapolis-based health sysÂtem. Quest stated, “Under the terms of the definitive agreeÂmen…
Significant Developments Are Shaping Lab Market
CEO SUMMARY: With 140 speakers and 1,000+ attendees, this year’s Executive War College again provided a comprehensive picture of the specific forces reshaping the U.S. market for lab testing services. Presented here is a smorgasbord of information and innovation shared by different spea…
Public IVD Companies Report Q4, Full-Year 2022 Earnings
YEAR-END AND Q4 EARNINGS REPORTS FROM MAJOR IN VITRO DIAGNOSTICS (IVD) COMPANIES pointed to a welcome sign of core diagnostic business rebounding. That’s the good news for IVD firms. The bad news? All of the SARS-CoV-2 testing revenue that th…
Top Public IVD Companies Report Q3/Q4 2022 Earnings
IT WAS A MIXED BAG OF THIRD QUARTER FINANCIAL RESULTS for the nation’s largest in vitro diagnostics (IVD) manufacturers, with COVID-19 testing volume a contributing factor. Fluctuating demand for SARS-CoV-2 testing proved perplexing, as some IV…
Ortho Clinical Diagnostics to Be Acquired by Quidel
CEO SUMMARY: In an announcement released before the end of 2021, Quidel said it had signed an agreement to acquire Ortho Clinical Diagnostics (OCD) for $6 billion. Laboratories that are customers of either company should expect changes after the deal closes as Quidel moves to integr…
Rural Hospital Lab Hits Automation Home Run
CEO SUMMARY: With the hospital adding specialist physicians and at the same time enjoying sustained growth in outreach test volume, the lab was hit with the dual need to expand the in-house test menu and reconfigure workflow to handle predictions of ongoing growth in outreach testin…
November 8, 2021 Intelligence: Late-Breaking Lab News
Last week, the state of California auto-renewed its controversial COVID-19 testing contract with PerkinElmer to run the Valencia Branch Laboratory. Designed, built, and operated by PerkinElmer, the lab began SARS-CoV-2 testing in the fall of 2020 and immediately was in the news for a range of …
September 27, 2021 Intelligence: Late-Breaking Lab News
Following the opening of her criminal trial in a Silicon Valley courtroom in recent weeks, Elizabeth Holmes—the disgraced ex-Founder and CEO of Theranos—continues to be the subject of news headlines. Federal prosecutors are calling witnesses to testify. Much of this testimony includes anec…
CURRENT ISSUE
Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
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