Emerging Tests

Test Makers, Retailers Are Raking in Money from Direct-to-Consumer COVID-19 Diagnostics

There is no disguising the fact that COVID-19 testing has proven to be a windfall for laboratories and the diagnostics industry. And even though the massive testing revenues of the past year are not … [Read more...]

LDTs

AACC Guidelines Caution Against Using Serology Tests to Determine COVID-19 Vaccine Efficacy

Although SARS-CoV-2 serology tests have yet to live up to the hype, they are still expected to play a crucial role in coronavirus infection control efforts going forward. In addition to accuracy … [Read more...]

Emerging Tests

Blood Test to Detect Early-Stage Lung Cancer Inches Closer to Reality

Maybe one day, medical science will find a way to eradicate lung cancer from the face of the earth. Until then, improving diagnosis of lung cancer at the early stages will remain an urgent priority. … [Read more...]

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...]

Testing Strategy

FDA to SARS-CoV-2 Test Developers: Evaluate Impact of Genetic Mutations on Test Performance

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

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

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

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

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

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...]


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