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Search Results for: COVID-19

Northwell Lab Team Validates COVID-19 Test on Fast Timeline

Clinical Laboratory Trends / By Joseph Burns

CEO SUMMARY: Clinical labs are working with haste to test for the novel coronavirus, also called nCoV and SARS-CoV-2. Their efforts to prepare for high capacity testing for viral respiratory illness include validating molecular tests for the newly-identified virus and making those tests available for testing patients who may have the COVID-19 illness. At Northwell …

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Labcorp, Quest Diagnostics Discuss Q4 & 2023 Earnings

Clinical Laboratory / By Robert Michel

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 numbers reported for test volume and pricing. Quest Diagnostics’ earnings call was first, on Feb. …

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Labs Should Prepare for Arrival of ‘Perfect Storm’

Clinical Laboratory Trends / By Robert Michel

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 reforms and updates to the 1992 CLIA rules. …

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

Managed Care Contracts / By Virchow

EDITOR’S NOTE: Our column, Virchow, is written by anonymous insiders working within the managed care world. The column aims to help clients of The Dark Report better understand the decisions, policies, and actions of payers as they manage their laboratory networks, establish coverage guidelines, process lab test claims, and audit labs. CONVENTIONAL WISDOM HOLDS THAT …

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FDA & CMS Issue Letter, Agree on LDT Oversight

Laboratory Compliance / By Robert Michel

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 specific roles each agency should have in the review and oversight …

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

Managed Care Contracts / By Virchow

EDITOR’S NOTE: Our column, Virchow, is written by anonymous insiders working within the managed care world. The column aims to help clients of The Dark Report better understand the decisions, policies, and actions of payers as they manage their laboratory networks, establish coverage guidelines, process lab test claims, and audit labs. CLAIM DENIALS BY COMMERCIAL …

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

Laboratory Management / By Robert Michel

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 results. The database, which was not password protected, contained approximately 1.3 million records, wrote …

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British Columbia Ready for HPV Self-Collection

Clinical Laboratory Trends / By Robert Michel

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 cancer screening will start with HPV tests, with patients collecting specimens …

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

Laboratory Management / By Robert Michel

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) Office of Inspector General (OIG) in a report …

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OPKO’s BioReference, Sonic Each Release Earnings Reports

Clinical Laboratory / By Robert Michel

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. BIOREFERENCE LABORATORIES: ‘Consistent Patient Volume’ During Q3, Compared to Prior Year Within OPKO’s third quarter conference call, data specific …

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