Industry Buzz

Guardant Health Challenges Exact Sciences’ Leadership of Colorectal Cancer Diagnostics Market

Colorectal cancer diagnostics is a multi-billion-dollar market that, at least before the pandemic, was projected to grow at an annual rate of nearly 6 percent. In recent months, two leading firms have … [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 Watch

Ortho Clinical Diagnostics Gets Green Light for Mass SARS-CoV-2 Antigen Test

Almost from the moment the pandemic began, high throughput testing for use in mass screening has occupied a high place on the FDA’s coronavirus diagnostics priority list. On Jan. 12, 2021, Ortho … [Read more...]

Special Focus

CBC Scoring of COVID-19 Inpatients May Help Hospitals Save Lives and Preserve Precious Treatment Resources

Early detection and early intervention have the potential to improve the prospects of recovery and positive outcomes for a broad range of diseases, including coronavirus. And now researchers in Europe … [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...]

Emerging Tests

Pairing of VOC Breathalyzer Testing and AI Cloud-Based Analysis Could Be Coronavirus Game Changer

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...]

FDA Watch

Agency Authorizes First OTC All-in-One At-Home COVID-19 Testing Kit

Since the pandemic began, the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for more than 225 COVID-19 diagnostic tests. Among these, 25 have been cleared for … [Read more...]

Emerging Tests

New Collaboration Seeks to Develop Handheld Breathalyzer Test for COVID-19

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...]

Inside the Lab Industry

Abbott and Quidel Stake Out Early Claims for Leadership of SARS-CoV-2 Rapid Antigen Testing Market

What COVID-19 antigen assays lack in accuracy with regard to RT-PCR testing is offset by their speed, low cost and scalability. In the long term, these advantages make point-of-care COVID-19 antigen … [Read more...]


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