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The Dark Report

Innovations in Lab Testing Arriving at Light Speed

Commentary and Opinion by R. Lewis Dark, Laboratory Compliance / R. Lewis Dark

TODAY, IT’S A CHALLENGE TO STAY UP WITH ALL THE NEW THINGS arriving in the lab testing marketplace. Novel assays are launched weekly. That is equally true for next-generation automation and lab analyzers, with vendors regularly announcing something new to their menu of products. The pace of innovation involving information technology is moving even faster. […]

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Medical Robotics Developer Says It’s Time to Transform Phlebotomy

Laboratory Equipment / Robert Michel

“Our innovation aims to make blood draws fully autonomous, safer, faster, more accurate, less painful, and more accessible.” —Brian Joseph, co-founder, Vitestro CEO SUMMARY: Phlebotomy and collection of veinous blood is one important procedure in clinical laboratory testing that continues to be primarily a manual process. That is about to change. Netherlands-based Vitestro has obtained

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Some Health Plans Drop Deductibles as Response to New Consumerism

Clinical Laboratory / Robert Michel

It may surprise many pathologists and clinical laboratory administrators to learn that one major health insurer’s best-selling plan has only copays and no deductible, no coinsurance, and no cost-shifting! That plan is Surest, a group plan offered by UnitedHealthcare in recent years. Becker’s Payer Issues wrote, “In 2022, the payer introduced Surest, a deductible-free offering

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March 10, 2025, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

Genetic testing is coming to a cruise ship! The New York Post reported that the MV Narrative will be launched this year by Storylines. CruiseCritic describes this vessel as “a residential ship that will create a floating ‘neighborhood’ for a community of up to 1,000 people, including families … With 547 ‘residences,’ owners buy into

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Upcoming Executive War College to Cover Important Lab Trends

Laboratory Information Systems / Robert Michel

New developments now changing the landscape in health-care and the clinical laboratory market will be addressed at the upcoming 30th Annual Executive War College on Diagnostic, Clinical Laboratory, and Pathology Management that happens on April 29-30, 2025, in New Orleans. That includes the ongoing uncertainty about the fate of the Food and Drug Administration’s (FDA)

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Optum Adds Gestalt to Its Digital Diagnostic Suite

Digital Pathology / Robert Michel

CEO SUMMARY: This development signals Optum’s intent to be a player in digital pathology. Its deal with Gestalt Diagnostics adds a pathology solution to Optum’s existing suite of cloud-based services for managing digital images generated by cardiology, radiology, and hematology-oncology. In this rapidly developing market segment, Optum competes against GE Healthcare, Siemens Healthineers, Philips, Sectra,

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Proposed Clinical Laboratory Price Transparency Bill

Laboratory Compliance / Robert Michel

IN DECEMBER, THE CLINICAL LABORATORY PRICE TRANSPARENCY ACT OF 2023 was referred to the U.S. House Ways and Means Subcommittee on Health for final approval. The bill requires labs to disclose information regarding pricing before administering services. The goal is to ensure patients better understand their healthcare costs. Restoring Transparency The bill was originally proposed

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Why Labs Should Comply with FDA’s Final Rule on LDTs

Laboratory Compliance / Robert Michel

CEO SUMMARY: Even as lawsuits challenging the Laboratory Developed Test (LDT rule) issued by the federal Food and Drug Administration (FDA) progress in federal court, clinical labs performing LDTs face an interesting decision. Should they invest the staff time and money to comply with the LDT rule’s Stage One requirements that take effect on May

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Quest Diagnostics, Labcorp Issue Q4 and Full Year 2024 Earnings

Laboratory Management / Robert Michel

LAB ACQUISITIONS IN 2024 WERE A CONTRIBUTING FACTOR TO REVENUE GROWTH at the nation’s two biggest clinical laboratory companies. This was reflected in the fourth quarter and full year 2024 earnings reports issued by Labcorp and Quest Diagnostics. Here are recently reported financial results from these publicly traded laboratories and highlights in diagnostics, acquisitions, and

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Grim Realities Drive Payer Behavior with Lab Test Claims

Managed Care Contracts / Robert Michel

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. Many, if not most,

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