TAG:
next generation sequencing
January 31, 2022 Intelligence: Late-Breaking Lab News
DNA-based breast cancer testing is taking a step forward. Illumina in San Diego, which sells next-generation sequencing (NGS) technology, announced a partnership with Agendia in Irvine, Calif., to develop in vitro diagnostic tests for oncology. Agendia offers proprietary breast …
Payers Continue to Increase Coverage of Liquid Biopsies
SINCE THE FIRST BLOOD-BASED, circulating-tumor DNA (ctDNA) sequencing test for cancer became available in 2014, federal and private payer coverage of these so-called “liquid biopsy” tests has increased substantially. Now, clinical laboratory and pathology directors can expect additional coverage …
India’s Neuberg Diagnostics Expands into U.S. Market
“Our idea is to enhance the access and affordability for next-generation techniques, meaning molecular diagnostics, genomics, pathology, digital pathology, proteomics, metabolomics, and all that. This is the spirit behind Neuberg Diagnostics. —GSK Velu, PhD, BPharm …
Response to FDA’s Gottlieb on Reducing Regulatory Burden
IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He …
FDA’s Gottlieb Favors Flexibility with LDTs, NGS
CEO SUMMARY: FDA Commissioner Scott Gottlieb said the FDA wants to reduce the regulatory burden on developers of next-generation sequencing (NGS) and laboratory-developed tests (LTDs). He also wants to give the FDA more flexibility in how it conducts clinical analysis and validation. To d…
Why Pharma, Private Equity Want to Reshape Lab Industry
CEO SUMMARY: A disruptive force that involves precision medicine, pharmaceutical companies, and venture capital investors is poised to reshape the clinical laboratory industry. Genetic knowledge makes it possible to match cancer drugs to specific mutations. Pharma companies and professio…
A coming transformation: Control over important diagnostic technologies is about to change hands
This is an excerpt from a 2,920-word article in the March 26, 2018, 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: He…
November 20, 2017 Intelligence: Late Breaking Lab News
Last Friday, Roche announced an agreement to acquire Viewics, Inc., of Sunnyvale, Calif., in a transaction that, subject to regulatory clearance, is expected to close on Nov. 21. Viewics sells a middleware analytics solution to clinical labs. Terms of the sale were n…
Anthem Launches Program to Manage Genetic Tests
CEO SUMMARY: Pre-authorization of genetic tests is coming to physicians serving patients insured by Anthem, Inc. Its specialty benefits management company, AIM Specialty Health, will manage the program. AIM will work with InformedDNA, a company that specializes in genetic testing clinical…
Palmetto GBA Issues Guidance On Billing NGS Test Panels
CEO SUMMARY: Across the lab industry, next generation sequencing is taking hold as an effective and efficient testing platform. In response, payers are developing coding and payment policies that may affect the finances of clinical labs. Last month, Palmetto GBA, a Medicare contractor, is…
CURRENT ISSUE
Volume XXIX, No. 11 – August 8, 2022
This issue examines the challenges facing the nation’s hospitals, health systems, and clinical labs: unprecedented shortages of lab staff, nurses, and other professionals with inflation-fueled cost increases and deteriorating hospital finances. Also, the issue delivers a case study showing how Bryan Health in Nebraska expanded its lab outreach program to include direct-to-consumer tests.
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