Daily Update

Tests with EUA

COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology Test (a) = Antigen Test (t) = Total Antibody Test) Date Manufacturer(s) Test Receiving EUA July … [Read more...]

Current Issue of NIR

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

Focus On

The Next Round of COVID-19 Legislation: What It Will Take to Prevent a Second Outbreak?

The next wave of federal COVID-19 relief legislation is in the works and the lab industry is doing its level best to ensure that it includes the necessary support for lab testing that the previously … [Read more...]

OIG Watch

Agency to Review First Two Years of PAMA-Based Medicare Reimbursements for Lab Tests

As we pass the midpoint of the third year of the PAMA experiment—if that’s what it is—the OIG announced plans to review what happened in years one and two. One of the new items on the agency’s Work … [Read more...]

New Products

First SARS-CoV-2 Antigen Test Gets EUA Clearance from the FDA

First came the molecular and then the serologic assays. And last month, the FDA granted emergency use authorization (EUA) for a COVID-19 assay based on a third kind of testing methodology: antigen … [Read more...]

Feds Charge Silicon Valley Med Tech Executive with Massive COVID-19 Stockholder Swindle

The executive of a publicly traded Silicon Valley medical tech firm has been charged with swindling investors and insurers by misrepresenting the diagnostic capabilities of a test using finger stick … [Read more...]

Congress to HHS

Give Labs the Money They Need to Develop COVID-19 Testing Capacity

This is a bad time to be a clinical lab in the U.S. Although a recovery seems to be in the works, the pandemic has drastically reduced testing for just about anything and everything other than … [Read more...]

Two New Bills

New Federal Legislation Would Give Labs Grants to Expand COVID-19 Testing Capacity

We all hope the worst of the pandemic is over and that life can get back to something like normal. But even as America reopens, the disturbing truth remains that the virus is still out there and that … [Read more...]

New Laws

HHS Requires Labs to Report Extensive & Unprecedented COVID-19 Testing Data by August 1

Three months into the pandemic, HHS has decided that it would be a good idea for labs that perform COVID-19 testing to report not only test results but other real-time data that labs generally don’t … [Read more...]

Labs In Court

A roundup of recent cases and enforcement actions involving the diagnostics industry

Whistleblower Lawsuit Can’t Start Until Criminal Investigation Ends  Case: Two former MedComp Laboratory Sciences employees filed a whistleblower lawsuit accusing the lab of concocting an elaborate … [Read more...]