Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

Volume XXXI, No. 2 - February 5, 2024

Read the Tea Leaves… FDA Will Require LDT Review

PROPOSED FEDERAL REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) IS CURRENTLY THE HOT-BUTTON ISSUE within the clinical laboratory industry. Following the close of public comments on Dec. 4, it is the quiet period while the federal Food and Drug Administration (FDA) reviews the comments and considers changes to the draft rule it issued on Sept. 29, …

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Who’s For and Against FDA Draft LDT Rule?

CEO SUMMARY: One analysis determined that 43.2% of the public comments were in support of the proposed LDT rule and 55.2% were in opposition to the rule. More telling, however, is that of the 2,900 comments in support, only 56 were not form letters! In contrast, about 1,300 individual comments were submitted in opposition (with …

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

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Feds Bar Elizabeth Holmes from Government Health Programs

ONCE AGAIN, ELIZABETH HOLMES, THE DISGRACED FORMER CEO OF THERANOS, is in the news. This time it is because the federal Department of Health and Human Services (HHS) Office of the Inspector General (OIG) announced in January that Elizabeth Holmes is barred from participating in federal healthcare programs for a period of 90 years. Holmes …

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

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

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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Invitae Cuts Costs to Rebuild Oncology Testing Pipeline

INVITAE CORPORATION, A MEDICAL GENETICS COMPANY that had a $1.34 billion loss during the nine months ending Sept. 30, 2023, recently announced coming actions to cut costs and change operations. The San Francisco-based company sold “certain reproductive health assets including carrier screening and non-invasive prenatal screening” to Natera, an Austin, Texas-based company offering cell-free DNA …

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February 5, 2024, Intelligence: Late-Breaking Lab News

In Australia last December, a clinical lab company was taken to court by the Office of the Australian Information Commissioner (OAIC), which deals with privacy issues. The government agency alleges that Australian Clinical Labs (ACL) had “serious and systemic” failures that enabled a cyberattack in 2022 to compromise the private health and financial data for …

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