FDA Watch

Newly Reintroduced VITAL Act Would Strip Agency of LDT Regulatory Authority

When history is written, acceleration of the longstanding effort to eliminate the authority of the U.S. Food and Drug Administration (FDA) to regulate Laboratory Developed Tests (LDTs) may be … [Read more...]

FDA Watch

Agency Okays COVID-19 Blood Spot Self-Collection & Molecular Test Pooling

Pandemic pressures continue to produce unprecedented action from the FDA. The current imperative is to clear assays and collection kits for rapid and easy screening, including products that can be … [Read more...]

M&A Report

PerkinElmer Turns COVID Cash into Acquisitions While Myriad Genetics Keeps Divesting

After a frantic month marked by an unusually high number of blockbusters, M&A deal making was relatively slow in May in terms of both deal volume and value. Still, the pace of strategic M&A … [Read more...]

Compliance Perspectives

Beware of Privacy Pitfalls When Remotely Monitoring Lab Telecommuters

Before the pandemic, 80 percent of U.S. employees worked primarily from an external workplace; today, only 21 percent do. Coaxing employees to return to the workplace will be an uphill battle, with … [Read more...]

Emerging Tests

Simple Urine Test May Be Capable of Predicting COVID-19 Case Severity

Analyzing a COVID-19 patient’s urine sample can help treatment providers predict how severe the case will be. That is the finding of a new study created by researchers from Detroit-based Wayne State … [Read more...]

Utilization Management

Congress Moves to Limit Prior Authorization Protocols of Medicare Advantage Plans

Prior authorization has been a perennial source of friction between payors and providers. While payors have a legitimate need to ensure program integrity and manage utilization of covered health … [Read more...]

Reimbursement

CMS Proposes to Ease, but Not End Hospital Price Transparency

If you’re a hospital lab administrator, you’ll probably be happy to learn that the Biden administration is proposing to repeal some of the more troublesome Trump price transparency rules relating. But … [Read more...]

DTC

Big Retail Chains Set to Roll Out Over-the-Counter COVID-19 Tests

DIY at-home COVID-19 testing using over-the-counter (OTC) test kits that don’t require a prescription is likely to become the new norm. With that clearly in mind, three of the country’s largest … [Read more...]

Technology & Innovation

CMS Delays New Rule Providing Automatic Medicare Coverage of Breakthrough Devices

A CMS final rule providing for automatic Medicare coverage for new medical products cleared by the FDA as breakthrough devices under Section 510(k) was supposed to take effect on March 15, 2021. But … [Read more...]

Genetic Testing

New Study Supports Use of Liquid Biopsy Technology to Bolster MRI Accuracy in Cancer Treatment

Important new evidence has emerged supporting the capabilities of liquid biopsy to enhance the accuracy of magnetic resonance imaging (MRI) for cancer diagnosis and treatment. That evidence comes from … [Read more...]


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