Zymo Research been granted 501(k) clearance by the US Food and Drug Administration (FDA) for DNA/RNA Shield Collection Tube as a Class II medical device. The 510(k) clearance allows the product to be used as an in-vitro diagnostic (IVD) device for detecting the SARS-CoV-2 virus.
Covid Apollo, a project bringing together capital and expertise to scale potential Covid-19 diagnostic capabilities, has announced a Series A investment in Rhinostics. The Harvard University spinout has developed a novel nasal collection swab that can increase sample throughput more than 10-fold while removing labour and errors from the laboratory workflow. The swab is integrated onto a cap that can be automated for removal from the tube while 96 samples are simultaneously accessioned through scanning a 2D barcode on the bottom of the tubes.
Applied DNA Sciences has received a purchase order for its Linea Covid-19 Assay Kit and consumables to carry out 10,000 tests under a Master Services Agreement with an existing customer. The company expects to deliver most of these Assay Kits by the end of 31 March 2021, with the remaining kits to be delivered in the following quarter. This is the company’s third such blanket purchase order from the customer to be used for pooled Covid-19 surveillance testing.