Emerging Tests

Leading COVID-19 Test Makers Say Their Products Can Detect New Omicron Variant

The World Health Organization (WHO) has declared the new omicron (B.1.1.529) viral mutation a “variant of concern.” But leading makers of COVID-19 diagnostic tests in the US seem unfazed and insist … [Read more...]

FDA Watch

Agency Regains Its Authority to Regulate Laboratory Developed Tests (LDTs)

In a surprising reversal of policy that had already been reversed in recent months, the US Department of Health and Human Services (HHS) announced that the US Food and Drug Administration (FDA) will … [Read more...]


CMS Repeals Rule Providing Expedited Medicare Coverage for MCIT “Breakthrough” Devices

It’s official. On Nov. 12, the US Centers for Medicare and Medicaid Services (CMS) announced that it was repealing a Trump administration final rule that, effective Dec. 15, 2021, would have expedited … [Read more...]

Becton Dickinson Lands $40.3 Million BARDA Contract to Develop 510(k)-Worthy COVID-19 Tests

Global medical tech company Becton Dickinson (BD) has been a leader in the effort to pioneer new diagnostic tests for COVID-19, having obtained FDA Emergency Use Authorization for COVID-19, flu A, and … [Read more...]

Compliance Alert

Not Following Government Guidance May Be Used Against You in False Claims Prosecutions

Unlike the regulations they purport to clarify, guidance materials issued by federal agencies don’t carry the weight of law. Accordingly, the longstanding efforts of the U.S. Department of Justice … [Read more...]

Enforcement Trends

Labs Figure Prominently in Latest DOJ Telemedicine, COVID-19 and Sober Homes Fraud Takedown

Telemedicine was a minor but growing blip on the enforcement radar before the public health emergency. But with the dramatic step up in utilization during the COVID-19 pandemic, it was all but … [Read more...]


Compliance Perspectives: How to Give Your Analog Workplace Harassment Policy a Digital Makeover

One of the only nice things about the pandemic is the relief it’s provided from workplace harassment. After all, employees are far less vulnerable to workplace harassment when they work from … [Read more...]


Delta Surge Lifts Demand for COVID-19 Tests & Profits of Laboratories that Produce Them

Remember back in the spring when Abbott, Quest and other COVID-19 testing laboratories announcing that test demand was falling fast and cautioning Wall Street investors to tone down their revenue … [Read more...]


White House Rolls Out Plan to Increase Nationwide Rapid, Point-of-Care COVID-19 Testing

Much has changed since the spring when Abbott, LabCorp, Quest and other major COVID-19 testing labs were demobilizing their coronavirus infrastructure and pivoting to normal business. The surge of new … [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...]