20 May 2020 - - US-based Biodesix, Inc., a diagnostic company in lung disease, has collaborated with Bio-Rad Laboratories, Inc. (NYSE: BIO) to launch a blood-based immunoassay-based test that identifies antibodies to SARS-CoV-2, the virus that causes COVID-19, the company said.

The Platelia SARS-CoV-2 Total Ab test was granted Emergency Use Authorization by the US Food and Drug Administration late last month, making it the first total antibody test to receive EUA from the FDA.

Clinical evaluation demonstrated specificity greater than 99 % and diagnostic sensitivity of 98% eight days after the onset of symptoms.

Cross-reactivity testing demonstrated specificity of 100% with no reactivity against other interfering specimens including non-CoV-2 coronaviruses.

After infection with SARS-CoV-2, viral antigens stimulate the body's adaptive immune system to produce antibodies to fight the virus. The Platelia SARS-CoV-2 Total Ab test identifies if a patient has produced those antibodies.

The Platelia SARS-CoV-2 test requires collection of a blood sample, which is sent to the CLIA-certified laboratory in De Soto, Kansas, for processing.

Results will be delivered in 24 hours. Biodesix currently has the capacity to process 14,000 tests a day.

The Platelia SARS-CoV-2 Total Antibody test can be utilised in combination with the SARS-CoV-2 Droplet Digital PCR (ddPCR) test to diagnose symptomatic patients and assess immunity in the population.

Biodesix is a diagnostic company with a focus in lung disease.

The company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence.

Biodesix is the first company to offer five non-invasive tests for patients with diseases of the lung. Most recently Biodesix has launched the SARS-CoV-2 ddPCR test in response to the global pandemic and virus that impacts the lung and causes COVID-19.

The blood-based Biodesix Lung Reflex strategy for lung cancer patients integrates the GeneStrat and VeriStrat tests to support treatment decisions with results in 72 hours, expediting time to treatment.

The blood-based Nodify Lung nodule risk assessment testing strategy consisting of the Nodify XL2 test and the Nodify CDT test evaluates the risk of malignancy in incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action.

Biodesix also collaborates with many of the world's leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease.