Public Health

U.S. Needs 200 Million COVID-19 Screening Tests Per Month to Reopen Safely, Says New Report

How many COVID-19 screening tests per month will it take for the U.S. to reopen safely? One new report estimates the number as around 200 million, which is far below the 25 million tests currently … [Read more...]

EUA

FDA to Issue Emergency Use Authorization for Multi-Analyte Respiratory Panels During the Pandemic

The convergence of flu season with the global COVID-19 pandemic will create the need for new multi-analyte respiratory panel tests that are capable of not only detection of but also differentiation … [Read more...]

PANDEMIC

Hospitals, Labs, LTCs Face Big Fines for Failing to Meet New CMS COVID-19 Test Daily Reporting Rules

Nursing and other long-term care (LTC) facilities have been a hotspot for COVID-19 infection since the public health emergency began. On Aug. 27, CMS issued a new Interim rule requiring LTC facilities … [Read more...]

Daily Update

Tests with EUA

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

DX Earnings Report

Q2 Revenues Slide but By Less than Wall Street Expected

As expected, the COVID-19 pandemic took a tremendous bite out of lab company earnings in the second quarter. However, the losses were largely below expectations, significantly below in many cases. And … [Read more...]

Tool

Telecommuter Home Office Hazard Assessment & Inspection Checklist

While not an OSHA obligation, it’s highly advisable to take measures to protect the health and safety of telecommuting lab employees who work from home. How? By having employees seeking approval to … [Read more...]

LDTs

FDA Breaks New Ground by Authorizing SARS-CoV-2 Tests for Sample Pooling

It’s not uncommon for the FDA to revise the Emergency Use Authorization (EUA) for a particular diagnostics test to permit a new clinical use. In most cases, these expansions don’t even get an official … [Read more...]

Testing Strategy

Labs to HHS: Since We Can’t COVID-19 Test Everyone, Let Us Prioritize the Symptomatic

Labs continue to lack the resources necessary to meet the demands for timely COVID-19 testing. In July, industry groups called on the White House to take control and resolve, or at least allay the … [Read more...]

FDA Watch

Saliva COVID-19 Tests Offer Way Around Nasopharyngeal Swab Shortage Bottlenecks

Shortages of the nasopharyngeal swabs used to collect respiratory samples for reverse transcription polymerase chain reaction (RT-PCR) tests has impeded the efforts of laboratories to meet the … [Read more...]

DATA

UK Antibodies Prevalence Study Suggests that Minorities Contract COVID-19 at Disproportionately Higher Rates

Many have suggested that minority populations have suffered adverse effects from COVID-19 disproportionate numbers. An August study from the United Kingdom provides powerful evidence to support this … [Read more...]


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