TAG:
the clinical laboratory
Proposed Bill in Congress Would Regulate LDTs
CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both …
Congress Seems Ready to Tackle LDT Regulation
RECENT DEVELOPMENTS SIGNAL THAT THE FIGHT over FDA regulation of laboratory-developed tests (LDTs) is about to intensify. Last month, two Congressional representatives announced a new bill about LDTs that they said was a “discussion draft.” The bill is titled the “Diagnostic Accuracy and Innova…
Federal Regulation of LDTs Subject of Proposed Bill
THERE’S A NEW BATTLE over laboratory-developed tests (LDTs) looming on Capitol Hill. In response to the FDA’s draft guidance to regulate LDTs, a bill has been proposed by two members of the house that would shape LDT regulations in different ways than proposed by the FDA. The Diagnostic Accuracy…
ARUP Laboratories Earns CAP’s ISO 15189 Accreditation
CEO SUMMARY: Being accredited to this internationally recognized standard for quality and competence communicates to clients and prospective clients that one of the nation’s largest clinical labs is committed to the highest standards of quality. Clients already knew about that commitmen…
PeaceHealth Outreach Laboratory Sells to Quest Diagnostics
This is an excerpt from a 1,471-word article in the February 21, 2017, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY…
PAMA Data Projections Led to Decision to Sell Lab
CEO SUMMARY: Following passage of the Protecting Access to Medicare Act of 2014, officials at PeaceHealth and PeaceHealth Laboratories began to model the financial effect this law would have on this long-established hospital lab outreach program. Based on projections of a 20% cut in reven…
PeaceHealth Labs Sold To Quest Diagnostics
CEO SUMMARY: In Oregon, one of the nation’s more successful and long-established health system outreach laboratories will cease to exist following its sale to Quest Diagnostics Incorporated. The seller explained that the Medicare Part B price cuts coming as a result of the PAMA market p…
Health System Lab Is Genotyping To Identify Best Drugs for Patients
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 …
Lab Innovators Advocate Need for Clinical Lab 2.0
CEO SUMMARY: It is generally recognized that the clinical lab industry faces a financial squeeze of unprecedented dimensions. Lab test prices are falling steadily and more major cuts are coming to Medicare Part B fees in just 11 months. At the same time, obtaining favorable coverage and r…
December 19, 2016 Intelligence: Late Breaking Lab News
Pathologists and lab managers interested in developing diagnostic management teams within their hospitals and health systems will be interested in an upcoming conference on that topic. Organized by Michael Laposata, MD, PhD, Chairman of the Department of Pathology at the University of Texas …
CURRENT ISSUE
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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