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Daily Update
Tests with EUA
March 1, 2021
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...]
Current Issue of DTET
March 1, 2021
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FDA Watch
2020 Was a Record Year for New Medical Device Approvals—And Not Just for COVID-19
February 21, 2021
They say that necessity is the mother of invention. But, historically, invention has never been the problem for creators of novel medical devices; the real challenge for these inventors has been more … [Read more...]
LDTs
FDA Clears Neutralizing Antibodies Detection Test for COVID-19
February 21, 2021
Innovative new COVID-19 tests continue to emerge from the pipeline. One of the novel diagnostic products that has flown slightly under the radar is the cPass SARS-CoV-2 Neutralization Antibody … [Read more...]
Informatics
Hologic Partners with Google Cloud to Enhance Cervical Cancer Screening
February 21, 2021
Hologic, Inc. announced on Feb. 1 that it has entered into a multi-year strategic collaboration with Google Cloud to augment the screening of cervical cancer by the integration of Google Cloud’s … [Read more...]
Genetic Testing
New Study Shows Viability of Using Ancestry to Compare Prostate Cancer Risk Across Populations
February 21, 2021
Ancestry has been shown to be a risk factor for prostate cancer. Unfortunately, we know very little about why men of certain races and ethnicities are more prone to get it, let alone how to use … [Read more...]
Emerging Tests
New Genomic Test Can Eliminate Up to One-Third of Medically Unnecessary Prostate Cancer Biopsies
February 21, 2021
Genetic testing has been shown to be effective in detecting prostate cancer and eliminating the need for unnecessary biopsies. And even though the current commercial market for such tests is crowded, … [Read more...]
Testing Strategy
The Biden Administration Initiates New Plan for National COVID-19 Testing
February 21, 2021
As with any other aspect of public life, the philosophy and views of the individual occupying the White House ultimately impact the direction of healthcare and diagnostics in the U.S. However, when a … [Read more...]
The Business of Testing
Hospital Laboratories Take a Stand Against Controversial UnitedHealthcare Outpatient Reimbursement Policy
February 21, 2021
The cold war between hospital laboratories and the nation’s third largest health insurer, UnitedHealthcare (UHC), over reimbursement of diagnostic tests is getting hotter by the day. At the center of … [Read more...]
