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...]

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...]

Laboratory Industry Report Newsletter Archive

By clicking on any of the links below you agree that you are the only person who is accessing your single user LIR subscription license and that you are not sharing your username and password with … [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...]

Emerging Tests

FDA Offers New Guidance on Validating SARS-CoV-2 Tests in “Non-Laboratory” Settings

SARS-CoV-2 testing in homes, workplaces, airports, schools, sports venues and other non-traditional diagnostic settings is likely to play an increasingly important role in the months ahead. The FDA … [Read more...]

FDA Watch

Agency Green Lights First SARS-CoV-2 Tests for Sample Pooling

Revising an Emergency Use Authorization (EUA) to permit a new clinical use is usually pretty routine stuff. But the expanded EUA the FDA announced on July 18 was both unprecedented and significant … [Read more...]

FDA Watch: Agency Sounds the Warning on False-Positives from Becton Dickinson SARS-CoV-2 Reagents

On July 6, the U.S. Food and Drug Administration (FDA) issued a warning letter alerting clinical laboratory staff and providers of the increased risk of false-positive results from Becton Dickinson … [Read more...]

Market Trends

COVID-19 Fuels Massive & Sustainable Growth in Molecular Diagnostics

While it may be decimating demand for most lab tests, COVID-19 is driving incredible growth in molecular testing. The global market for molecular diagnostics will top $13 billion in 2020, about $5 … [Read more...]

M&A Report

Surging Demand for COVID-19 Testing Forces Thermo Fisher to Raise Its Offer for Qiagen

Back in March, Thermo Fisher Scientific announced that it had agreed to acquire Qiagen for $11.5 billion. At the time, the €39 (roughly $46) per share representing a premium of 23 percent over the … [Read more...]


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