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COVID-19

Labcorp, Quest Diagnostics Discuss Q4 & 2023 Earnings

DURING RECENT EARNINGS CALLS WITH FINANCIAL ANALYSTS AND INVESTORS, both Labcorp and Quest Diagnostics discussed their fourth quarter (Q4) and full year 2023 financial results. Each reported some stability in the market for clinical laboratory testing services, reflected in the numbe…

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Labs Should Prepare for Arrival of ‘Perfect Storm’

CEO SUMMARY: In the near future, clinical labs and pathology groups will need to address three major developments. One involves the FDA proposed LDT rule. A second is the adoption by payers of guidelines that require genetic test claims to have Z-Codes. The third centers around coming ref…

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Is There Evidence That Some Doctors Wish to Use Local Labs?

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FDA & CMS Issue Letter, Agree on LDT Oversight

CEO SUMMARY: With the release of a public statement about the oversight of LDTs on Jan. 24, 2024, officials at both the Food and Drug Adminstration and the Centers for Medicare and Medicaid Service went on record that both agencies are aligned in the spec…

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Published Data Show Claim Denials on the Rise, But Why?

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European Lab’s Data Breach Has Lessons for U.S. Clinical Labs

IN WHAT COULD BE A CAUTIONARY TALE FOR CLINICAL LABORATORIES, a cybersecurity researcher has reported the discovery of a medical laboratory database that publicly exposed COVID-19 test records containing people’s personal data, including their names, passport numbers, appointment details, and test …

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British Columbia Ready for HPV Self-Collection

CEO SUMMARY: Unacceptable delays of as long as six or seven months in reporting Pap smear test results is triggering a major change in how provincial health authorities screen for cervical cancer. For example, health officials in British Columbia announced that, going forward, cervical ca…

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OIG Reports Its Findings about CDC’s First COVID Test Problems

ONE MAJOR FAILURE BY FEDERAL AGENCIES in the first days of the COVID-19 pandemic was the development and release of an inaccurate and unreliable SARS-CoV-2 test, intended for use by public health labs. This was the finding of the U.S. Department of Health and Human Services (HHS) …

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OPKO’s BioReference, Sonic Each Release Earnings Reports

BELOW IS A SUMMARY OF RECENT FINANCIAL EARNING REPORTS for OPKO’s BioReference Laboratories and Sonic Healthcare Ltd’s lab operations in the U.S. This finishes our coverage of Q3-23 financial reporting by the larger public laboratory corporations. …

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Violating EKRA Earns Lab Owner an Eight-Year Prison Sentence

THIS MAY BE THE MOST HIGH-PROFILE CASE involving a clinical laboratory and the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Former Arrayit Corporation president Mark Schena was sentenced in October 2023 to eight years in federal prison and ordered to pay $24 million in resti…

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