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January 2024

British Columbia Ready for HPV Self-Collection

Clinical Laboratory Trends / By

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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FDA Has a Ticking Time Bomb with LDT Rule

Commentary and Opinion by R. Lewis Dark / By

PROPOSED REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) by the federal Food and Drug Administration (FDA) may be the single topic of highest interest within the clinical laboratory and in vitro diagnostics (IVD) industries at this moment. If finalized in its draft form, the new regulation will radically transform a sector of laboratory medicine that uses …

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Google, Epic to Help Hospitals Migrate EHR Data to Cloud

Laboratory Management / By

GOOGLE CLOUD OF MOUNTAIN VIEW, CALIF., inked a new deal with Epic Systems designed to encourage healthcare providers to move electronic health record (EHR) data to the cloud. This relationship will include efforts to step up the use of artificial intelligence (AI) and data analytics. The deal was announced in November and included news that …

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September Saw 153% Increase in Ransomware Attacks

Laboratory Management / By

CEO SUMMARY: Most ransomware attacks don’t generate news stories because the victimized organizations don’t want other threat actors to learn if they paid a ransom to regain access to their information systems. Experts point out that more cyberattacks are happening and that the attacks are becoming more sophisticated. That includes a new tool for the …

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23andMe Says Big Data Breach Due to Customers’ ‘Negligence’

Genetic Testing / By

LAST OCTOBER, ONE HIGH PROFILE COMPANY THAT DOES GENETICS TESTING acknowledged it had experienced a data breach involving thousands of its customers. Then came an unexpected turn in this data breach event. In subsequent public statements during December, 23andMe stated that the original announcement of a data breach involving about 14,000 consumers was only the …

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Lab News Briefs

Clinical Laboratory Trends / By

Siemens to Explore Sale of Its IVD Diagnostics Unit Siemens Healthineers, Erlangen, Germany, is reportedly looking into options for sale of its in vitro diagnostics (IVD) segment. The company’s “review could lead to sale of the [diagnostics] unit, but all options remain open,” a source reportedly told Reuters. Bloomberg Law said Siemens may be able …

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Layoffs at Major Health Plans Slow Processing of Lab Claims

Managed Care Contracts / By

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. HEALTH INSURERS WANT TO …

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

Laboratory Management / By

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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January 16, 2024, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By

If a patient’s genetic test generates results that are actionable, will that patient move forward with treatment? That is one question asked by researchers in a study led by Vanderbilt University Medical Center that was published in the American Journal of Human Genetics. A pool of 16,218 research participants were genotyped. “Genetic counselors at six …

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