Hologic has announced that its Aptima SARS-CoV-2 assay, which secured Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) in May, is now authorised for testing of individuals who do not show symptoms but have reason to suspect Covid-19 infection. So far, Hologic has produced tens of millions of SARS-CoV-2 assays.
Quanterix, a company digitising biomarker analysis, has secured a Phase 2 contract from the National Institutes of Health (NIH) through its Rapid Acceleration of Diagnostics (RADx) initiative. This contract, which carries a total value of $18.2m, will speed up the development and deployment of SARS-CoV-2 antigen testing, based on Quanterix’ ultra-sensitive Simoa technology. According to preliminary results, the test has shown the potential to detect from a variety of sample types including self-collected capillary blood, saliva and nasal swabs.
Qosina now carries a sterile 3D-printed nasopharyngeal Covid-19 testing swab for nasal mucosa specimen collection. The 3D-printed sterile swab, developed by in vitro diagnostic and medical device manufacturer Resolution Medical, is claimed to be a cost-effective alternative to the conventional nasopharyngeal swab. It can be produced quickly through existing, industry-approved materials and the Carbon Digital Light Synthesis 3D printing process.
Medicom, a manufacturer of surgical and respiratory masks, has announced the expansion of its mask manufacturing operations in the US. The company will add a second factory with triple the square footage of its current United Medical Enterprise facility in Augusta, Georgia. This new facility will accommodate new surgical and N95-type mask production equipment.
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