molecular lab Archives

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Global IVD Companies Issue Fourth Quarter 2024 Earnings

By Robert Michel | From the Volume XXXII, No. 5 – March 31, 2025 Issue

OVERALL, IN VITRO DIAGNOSTICS (IVD) COMPANIES REPORTED A MIXED BAG of financial results for the quarter ending Dec. 31, 2024, with Becton, Dickinson and Company, Abbott Laboratories, and Siemens Healthineers showing the most momentum based on r…

Alverno Labs Adds Eight Hospitals to Its Network

By Joseph Burns | From the Volume XXVI No. 14 – October 14, 2019 Issue

CEO SUMMARY: In September, Alverno Laboratories, one of the largest networks of regional laboratories in the Midwest, added two Chicago hospital laboratories and six other hospital labs from the AMITA Health system to its network. The additional AMITA Health facilities joined Alverno as a…

ACLA: NCCI Guidelines Are a ‘Step Backwards’

By Joseph Burns | From the Volume XXVI No. 6 – April 29, 2019 Issue

CEO SUMMARY: In a letter to the National Correct Coding Initiative, the American Clinical Laboratory Association (ACLA) raised significant concerns about new language in the policy manuals for Medicare and Medicaid. ACLA said the new NCCI guidelines for molecular and other tests requiring…

XIFIN CEO White Analyzes Medicare 2018 Fee Cuts

By R. Lewis Dark | From the Volume XXIV No. 14 – October 9, 2017 Issue

CEO SUMMARY: If the draft lab rates that CMS published Sept. 22 for the Clinical Laboratory Fee Schedule for 2018 go into effect Jan. 1 as proposed, then clinical labs will see a cut of 28% in what they get paid for the top 20 most common tests, according to a recent analysis. The rates t…

UnitedHealth to Start Gene Test Pre-Approval

By Joseph Burns | From the Volume XXIV No. 12 – August 28, 2017 Issue

CEO SUMMARY: With programs now at the nation’s two largest insurers, is it possible to argue that prior-authorization is going mainstream? Some observers say, yes, as THE DARK REPORT predicted. What is certain is that starting Nov. 1, UnitedHealthcare is requiring prior authorization fo…

Digital Pathology Systems Will Create Opportunities

By R. Lewis Dark | From the Volume XXIV No. 7 – May 15, 2017 Issue

CEO SUMMARY: Advanced Pathology Associates, a 15-member private pathology group practice, had the distinction of generating data for the clinical study that Philips submitted to the Food and Drug Administration for review of its whole slide imaging system. Following the FDA’s decision t…

Health System Lab Is Genotyping To Identify Best Drugs for Patients

By Joseph Burns | From the Volume XXIV No. 2 – January 30, 2017 Issue

CEO SUMMARY: One essential element of precision medicine will be the regular use of pharmacogenomic testing to provide additional guidance to physicians when selecting the most appropriate therapeutics and optimal dose for each individual patient. Despite the reluctance of private payers …

PAMA Economics Drives Merger Of Two Seattle-Area Pathology Groups

By Joseph Burns | From the Volume XXIV No. 1 – January 9, 2017 Issue

CEO SUMMARY: Among the three chief reasons for the merger of CellNetix and Puget Sound Institute of Pathology, the most compelling was the need to address the challenges in the current reimbursement environment and to prepare for reductions in payment to pathologists expected in the comin…

Market Price Data Sample from: Molecular/Genetic Labs

By Robert Michel | From the Volume XXIII No. 15 – November 7, 2016 Issue

Here is the market price data for molecular and genetic labs from XIFIN Inc. Lâle White, Founder and CEO of XIFIN, discusses the data with THE DARK REPORT. EDITOR: When you did this analysis of molecular and genetic…

Genetic Testing Lab Finds Payers Respond To Education on Test Utility

By Joseph Burns | From the Volume XXIII No. 8 – June 13, 2016 Issue

CEO SUMMARY: In recent years, insurers have raised the bar and become much tougher when making coverage and reimbursement decisions for molecular assays, genomic, and genetic tests. Yet several lab testing companies are having good success at demonstrating the validity and clinical utilit…

Volume XXXII, No. 6 – April 21, 2025

Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.

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