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molecular testing

Despite COVID-19 Losses, IVD Executives Remain Upbeat

Continuing declines in COVID-19 test revenues was a common theme during the first quarte…

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Payers Request More Claims Documentation

CEO SUMMARY: Both anecdotal evidence from lab professionals and numbers-based data from XiFin point to a problem: More payers require clinical labs to produce more documentation that a test claim i…

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Post-COVID: Repurposing Excess PCR Instruments

CEO SUMMARY: Currently, there are hospital, health system, and independent clinical laboratories that have between two and five different PCR testing platforms. These analyzers were acquired during the pandemic as one way to increase the daily number of SARS-CoV-2 their labs could p…

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November 4, 2019 Intelligence: Late Breaking Lab News

Pharmacogenetic testing is gaining acceptance by a growing number of health insurers. On Oct. 1, UnitedHealthcare (UHC) began coverage of genetic tests that help physicians identify the anti-depressant drugs most likely to benefit their patients. UHC’s policy also extends coverage …

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October 14, 2019 Intelligence: Late Breaking Lab News

Two interesting partners are working on a project to map the human immune system with the goal of creating a knowledge base that can be used to develop diagnostic tests. Microsoft and Adaptive Biotechnologies of Seattle are collaborating on this project. “Google c…

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PGx Testing Labs Concerned by FDA’s Statements, Actions

This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…

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PGx Labs Concerned by FDA’s Statements, Actions

CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…

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Labs Get High Denial Rates Under New NCCI Rules

CEO SUMMARY: Under guidelines the National Correct Coding Initiative issued last year, many clinical laboratories are not getting paid for some tests. The rates of denial for labs running mostly molecular tests could range from 40% to 100% of revenue, one billing expert said. Implemented …

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Nine Lab Groups Say New NCCI Policy Is Inconsistent

CEO SUMMARY: By its name alone, the National Correct Coding Initiative (NCCI) Policy Manual implies that it will be accurate and consistent with other coding initiatives. But nine groups representing various clinical laboratories say NCCI guidelines that the federal Centers for Medicare a…

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Sonic to Pay $540 Million to Buy Aurora Diagnostics

CEO SUMMARY: Sonic Healthcare, Ltd., announced that it would pay $540 million—a multiple of 9.2 times EBITDA—to acquire Aurora Diagnostics, the anatomic pathology company based in Palm Beach Gardens, Fla. Sonic will gain 32 pathology practice sites and add 220 pathologists to its netw…

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