What Labs with LDTs Must Do to Comply with FDA’s LDT Rule

By Robert Michel | From the Volume XXXI, No. 10 – July 22, 2024 Issue

CEO SUMMARY: Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This com…

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UK’s Genomics PLC and MassMutual Offer Free Genetic Testing to Members

By Robert Michel | From the Volume XXXI, No. 9 – July 1, 2024 Issue

CONSUMER-DRIVEN HEALTHCARE PAIRED WITH A FOCUS ON PRE­VENTATIVE MEDICINE has given birth…

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What if Congress Chooses to Pass an LDT-Specific Law?

By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue

CONGRESS HAS YET TO SPEAK SPECIFICALLY ON THE ISSUE of regulating laboratory developed test…

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Labcorp, Quest Issue Q1 Earnings, Offer Comments on FDA’s LDT Rule

By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue

  BOTH LABCORP, BURLINGTON, N.C., AND QUEST DIAGNOSTICS, SECAUCU…

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Payer Contracts with Labs: Getting the Contract Is Just the Start

By Virchow | From the Volume XXXI, No. 6 – April 29, 2024 Issue

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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…

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Is Mobile Phlebotomy a Timely Service to Offer Health Plans?

By Virchow | From the Volume XXXI, No. 4 – March 18, 2024 Issue

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HHS Publishes Final Rule for Health IT Interoperability

By Robert Michel | From the Volume XXXI, No. 3 – February 26, 2024 Issue

THERE IS A NEW FEDERAL RULE intended to improve interoperability and portability of patient information. This rule could be a significant benefit for clinical laboratories and anatomic pathology groups. In December, the US Department of Health and Human Services (HHS) Offi…

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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…

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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) …

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