TAG:
COVID-19
FDA Issues Memo to Reclassify Many High Risk IVD Assays
By Robert Michel | From the Volume XXXI, No. 5 – April 8, 2024 Issue
WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…
Labcorp, Quest Diagnostics Discuss Q4 & 2023 Earnings
By Robert Michel | From the Volume XXXI, No. 4 – March 18, 2024 Issue
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…
Labs Should Prepare for Arrival of ‘Perfect Storm’
By Robert Michel | From the Volume XXXI, No. 3 – February 26, 2024 Issue
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…
Is There Evidence That Some Doctors Wish to Use Local Labs?
By Virchow | From the Volume XXXI, No. 3 – February 26, 2024 Issue
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FDA & CMS Issue Letter, Agree on LDT Oversight
By Robert Michel | From the Volume XXXI, No. 2 – February 5, 2024 Issue
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…
Published Data Show Claim Denials on the Rise, But Why?
By Virchow | From the Volume XXXI, No. 2 – February 5, 2024 Issue
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European Lab’s Data Breach Has Lessons for U.S. Clinical Labs
By Robert Michel | From the Volume XXXI, No. 2 – February 5, 2024 Issue
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 …
British Columbia Ready for HPV Self-Collection
By Robert Michel | From the Volume XXXI, Number 1 – January 16, 2024 Issue
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…
OIG Reports Its Findings about CDC’s First COVID Test Problems
By Robert Michel | From the Volume XXXI, Number 1 – January 16, 2024 Issue
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) …
OPKO’s BioReference, Sonic Each Release Earnings Reports
By Robert Michel | From the Volume XXX, Number 18 – December 26, 2023 Issue
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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