Coronavirus company news summary – Helix gets EUA for its Covid-19 NGS Test – Thermo Fisher Scientific develops Covid-19 antibody assay for transplant community

11 August 2020 (Last Updated August 11th, 2020 09:11)

Genomic company Helix has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for the Helix COVID-19 NGS Test. This is an amplicon-based next-generation sequencing (NGS) test meant for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens of individuals suspected to be infected with Covid-19.

Fapon Biotech has announced a new Covid-19 donation to meet the demand for development and optimisation of quality controls for antibody tests by donating 100 million anti-SARS-CoV-2 fully human RBD IgM & IgG QC test materials. In February, it made the first donation of three million PCR test components to cut down the shortage of raw materials. The latest donation underpins Fapon's corporate mission to enable earlier disease identification, more convenient, accurate and affordable diagnosis to fight Covid-19.

Thermo Fisher Scientific has developed a new serological assay for transplant candidates and recipients to detect antibodies directed against Covid-19. The assay will be provided under its One Lambda brand. In collaboration with Emory University, Stanford University, University of Cincinnati and the University Health Network in Toronto, Thermo Fisher has developed the LABScreen COVID Plus Assay. The assay taps the Luminex xMAP technology to identify several unique antibodies and fragments, thereby making it more specific than present assays and able to cut down false positives caused by infections with common coronavirus. Along with HLA antibody detection, the LABScreen COVID Plus reagents can help give a full picture of a patient's antibody profile.

Nanotronics Health, a subsidiary of Nanotronics, has received EUA for its non-invasive ventilator, nHale, for at-home use. Nanotronics Health also received authorisation for the nHale to be used with supplemental oxygen under a doctor’s prescription. Nanotronics Health president Julie Orlando said: “We wanted to provide hospitals and consumers with an affordable respiratory option to promote healing and aid the treatment of Covid-19. An innovative manufacturing vision was essential for building and scaling this critical device quickly—to get it in the hands of those who need it most.”