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...]
INDUSTRY TRENDS
Tech Giants Continue Efforts to Disrupt Healthcare Despite Shutdown of Google Health
October 23, 2021
Global Markets
EC Announces New Plan to Roll Out In Vitro Diagnostic Regulation
October 23, 2021
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
October 23, 2021
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
October 23, 2021
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
October 23, 2021
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
October 5, 2021
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
October 5, 2021
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
October 5, 2021
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
October 5, 2021
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
September 30, 2021
Before You Download Please read the following user agreement and confirm your acceptance of the terms before you download DTET content: I agree that I am the the only person who is accessing my … [Read more...]
