INDUSTRY TRENDS

Tech Giants Continue Efforts to Disrupt Healthcare Despite Shutdown of Google Health

Another attempt by an outsider to disrupt the healthcare market has come to an unfulfilling end. As first revealed by a leaked internal memorandum, after three years of operation, Google has decided … [Read more...]

Global Markets

EC Announces New Plan to Roll Out In Vitro Diagnostic Regulation

If your laboratory company does business in Europe, it needs to be tuned in to the dramatic regulatory changes that are slated to go into effect in 2022. The key date is May 26 when the European … [Read more...]

Emerging Tests

Game Changers: Scientists in China Develop Rapid Breath Test for COVID-19

Breathalyzer tests capable of rapid detection of SARS-CoV-2 would go a long way in simplifying and broadening access to coronavirus screening testing. Now comes word that a team of researchers in … [Read more...]

COVID-19

AACC Doubles Down on Not Using CT Values to Evaluate Performance of SARS-CoV-2 PCR Tests

Laboratories and health care providers should not use cycle threshold (CT) values to measure the performance of polymerase chain reaction (PCR) tests for SARS-CoV-2. That was the advice of the … [Read more...]

FDA

False Positive Recalls Casts Doubt on Rapid COVID Screening Tests at the Worst Possible Time

Late last year, the US Food and Drug Administration (FDA) began issuing emergency use authorization (EUA) for a new breed of COVID-19 tests designed not so much to diagnose but screen for the virus on … [Read more...]

EMERGING TESTS

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...]

EUA

FDA Requires EUA SARS-CoV-2 Test Developers to Account for Viral Mutations

New rules from the U.S. Food and Drug Administration (FDA) require producers of SARS-CoV-2 tests that have received Emergency Use Authorization (EUA) to take additional steps to account for viral … [Read more...]

FDA Watch

Agency Finalizes Rule on Off-Label Uses Liability and Rights of Laboratories to Create LDTs

On Aug. 2, 2021, the U.S. Food and Drug Administration (FDA) published the long-awaited final rule updating its “intended use” regulations for medical devices and drugs. Here is a quick briefing of … [Read more...]

Testing Trends

Tapping AI and Deep Learning to Personalize Breast Cancer Screening for Women

A new study suggests that use of an artificial intelligence (AI) algorithm may provide the key to creating personalized breast cancer screening protocols for women based on the results of their … [Read more...]

Current Issue of DTET

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