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...]
Testing Strategy
FDA to SARS-CoV-2 Test Developers: Evaluate Impact of Genetic Mutations on Test Performance
March 23, 2021
Evolution and mutation of SARS-CoV-2 virus has made COVID-19 diagnosis a moving target. On Feb. 22, 2021, the U.S. Food and Drug Administration issued new guidance telling developers of SARS-CoV-2 … [Read more...]
Emerging Tests
New Genomic Test Can Eliminate Up to One-Third of Medically Unnecessary Prostate Cancer Biopsies
March 23, 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...]
Emerging Tests
FDA Clears the Way for Serial Use At-Home and Point-of-Care Asymptomatic Screening Tests
March 23, 2021
At-home and point-of-care (POC) serial testing for purposes of screening the asymptomatic is, arguably, the most promising, long-term market for new SARS-CoV-2 diagnostics. On March 16, 2021, the U.S. … [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...]
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...]
FDA
Neutralizing Antibodies Detection Test for COVID-19 Gets the FDA Greenlight
January 30, 2021
Innovative new COVID-19 tests continue to emerge from the pipeline. One of the products that has flown slightly under the radar is the cPass SARS-CoV-2 Neutralization Antibody Detection Kit from … [Read more...]
Emerging Tests
Pairing of VOC Breathalyzer Testing and AI Cloud-Based Analysis Could Be Coronavirus Game Changer
January 29, 2021
A handheld, easy-to-use breathalyzer device capable of accurately detecting COVID-19 at the point of care would represent a major breakthrough in the effort to contain the spread of the virus. That … [Read more...]
Emerging Tests
Studies Show Blood Testing May Be Just as Good If Not Better than PET Scans in Detecting Early Alzheimer’s Disease
January 4, 2021
For decades, researchers have worked to create a cost-effective and accurate blood test for early detection of Alzheimer’s disease. A new study suggesting that elevated levels of the protein tau … [Read more...]
Emerging Tests
Roche, Siemens Healthineers Score Big on FDA SARS-CoV-2 Antibodies Test Reliability Evaluation
January 4, 2021
While real-time reverse transcription polymerase chain reaction (RT PCR) assays are the primary diagnostic for COVID-19, the U.S. Food and Drug Administration (FDA) has also granted Emergency Use … [Read more...]
