FDA Watch

Final Rule Clarifies Liability for Off-Label Uses and Lab’s Right to Create LDTs

On Aug. 2, 2021, the FDA published the long-awaited final rule updating its “intended use” regulations for medical devices and drugs. Here’s a quick briefing of the new rules, which took effect on … [Read more...]

M&A Report

Illumina Makes Audacious Move by Completing Grail Acquisition Without Regulatory Approval

It’s damn the torpedoes and full speed ahead for Illumina. Recognizing that it had no chance of securing the necessary regulatory approval in time to make the hard closing deadline and staring a $300 … [Read more...]

DX Deals

Labcorp Teams with Oncology Research Startup to Eliminate Demographic Disparities in Cancer Treatment

Studies show that demographic differences can impact cancer care and that disadvantaged populations suffer from a lack of access to advanced precision cancer diagnostics and treatments. Evaluating and … [Read more...]

Inside the Lab Industry

Resurgence of COVID-19 Cases Threatens to Derail Recovery of Core Business

Back on July 1, the perception was that the demand for COVID-19 testing was falling off faster than predicted. The silver lining to this cloud was the stronger than expected recovery of core … [Read more...]

INNOVATION

Tech Giants Continue Efforts to Disrupt Healthcare Despite Google Health Shutdown

Another attempt by an outsider to disrupt the healthcare market is apparently coming to an end. According to a leaked internal memo, after three years of operation, Google has decided to unwind its … [Read more...]

Current Issue of LIR

Before You Download Please read the following user agreement and confirm your acceptance of the terms before you download LIR content: I agree that I am the the only person who is accessing my … [Read more...]

DX Deals

Amazon Already Making a Mark on Direct-to-Consumer COVID-19 Test Market

Will Amazon transform diagnostic lab testing the way it did the retail industry? Probably not. But the tech giant with the proven capacity to reach into the home and change the shopping patterns of … [Read more...]

M&A Report

Biden Orders Feds to Target Health Care Consolidation but Deals Continue

This month’s big stories in M&A deal making come not just from the market but the regulatory front. New Biden Executive Order Targets Health Care Consolidation Consolidation in the health … [Read more...]

Inside the Lab Industry

AI Imaging Drives Modest Uptick in Digital Pathology Investment Flows

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Reimbursement

New LCD Expanding Medicare Coverage for Circulating Tumor Cells Tests Is a Win for Biocept

Biocept announced that it has received expanded Medicare coverage for use of its Target Selector assay to identify HER-2 positive circulating tumor cells under a final CMS local coverage determination … [Read more...]


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