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FDA Clears Digital Path for Primary Diagnosis
CEO SUMMARY: Proponents of digital pathology systems and whole slide imaging achieved a milestone on April 12 when the FDA cleared the Philips digital pathology system for sale in the United States. Now pathologists can use the system to perform primary diagnoses and get paid for those pr…
Aurora Diagnostics Acquires Pathology Groups, Posts Loss
ONE OF THE MORE CURIOUS SITUATIONS IN THE LAB INDUSTRY TODAY is the story of Aurora Diagnostics of Palm Beach Gardens, Fla. Even as it loses money, it continues to acquire pathology group practices. Aurora recently issued its earnings report. For 2016, it disclosed a net loss of $29…
More Hospitals Consider Options for Their Labs
CEO SUMMARY: Is it a new sign of the times? After decades of reluctance to sell their lab outreach businesses or enter into inpatient lab management agreements with commercial lab companies, a surprising number of hospitals and health systems are taking that step. Since the first of the y…
Federal Regulation of LDTs Subject of Proposed Bill
THERE’S A NEW BATTLE over laboratory-developed tests (LDTs) looming on Capitol Hill. In response to the FDA’s draft guidance to regulate LDTs, a bill has been proposed by two members of the house that would shape LDT regulations in different ways than proposed by the FDA. The Diagnostic Accuracy…
CMS Extends Reporting of Payer Prices by 60 Days
CEO SUMMARY: Last Thursday, the federal Centers for Medicare and Medicaid Services said it was extending the deadline for certain labs to report their private payer lab test prices by an additional 60 days, until May 30. Statements by CMS officials indicate that either or both the number …
ARUP Laboratories Earns CAP’s ISO 15189 Accreditation
CEO SUMMARY: Being accredited to this internationally recognized standard for quality and competence communicates to clients and prospective clients that one of the nation’s largest clinical labs is committed to the highest standards of quality. Clients already knew about that commitmen…
Lab Acquisitions: LabCorp, Quest, Sonic Do Hospital Lab Deals
This is an excerpt from a 1,021-word article in the March 13, 2017, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: …
LabCorp, Quest, Sonic Do Hospital Lab Deals
CEO SUMMARY: Is the New Year’s spate of deals involving the sales of hospital lab outreach programs and a new joint venture the first tremors of an impending earthquake of similar transactions? In the first 10 weeks of 2017, Laboratory Corporation of America, Quest Diagnostics, and Soni…
Sonic, Western Connecticut Health Network Announce New Laboratory Joint Venture
CEO SUMMARY: To prepare for the transition from fee-for-service to value-based payment, Western Connecticut Health Network, a three-hospital health system, announced a laboratory joint venture with Sonic Healthcare. Benefits will include lower test costs, more competitive prices, and the …
Labs Ask: Does PAMA Statute Prevent Legal Challenges?
SINCE MEDICARE OFFICIALS PUBLISHED the final rule for lab test market price reporting of private payer prices last year, clinical lab industry consultants and lawyers have raised serious criticisms of the rule. The critics recognized that CMS officials wrote a final rule for the Protecting Access to…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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