Therapy Areas: Devices
Zymo Research's SafeCollect Saliva Collection Kit receives US FDA approval
16 November 2023 -

Zymo Research, a California-based privately owned company that has been serving the scientific and diagnostics community with state-of-the-art molecular biology tools, announced on Wednesday that it has received approval from the US Food and Drug Administration (FDA) for its DNA/RNA Shield SafeCollect Saliva Collection Kit as a Class II medical device for microbial nucleic acid storage and stabilisation.

The FDA's 510(k) clearance allows the product to be used as an In-vitro Diagnostic (IVD) device for saliva collection and transport.

The SafeCollect Saliva Collection Kit has specifically been granted approval for COVID-19 testing. It is the first FDA-approved inactivating transport medium (ITM) to demonstrate inactivation and preservation of the SARS-CoV-2 RNA virus.

The company said that the product features a user-friendly spit funnel with an innovative safety seal designed to prevent accidental spillage or user exposure to the DNA/RNA Shield preservative reagent in the tube. The technology is compatible with human saliva suspected to contain SARS-CoV-2. Specimens collected and stored are suitable for use with appropriate molecular diagnostic tests.

Dr Stanislav Forman, CTO of Sample Prep at Zymo Research, said, 'Non-invasive saliva collection is vital for the molecular diagnostics field, unlocking a wealth of genetic and biomolecular information with ease and comfort, paving the way for groundbreaking advancements in personalized healthcare and disease detection. This 510(k) clearance highlights the FDA's initiative in bringing enabling technologies to the maturing molecular diagnostic space.'