MK-00635: DNA from saliva: ORAcollect®•Dx performance as demonstrated through 510(k) validation studies (pdf)

Molecular diagnostic tests allow for the rapid and accurate detection of biomarkers. Achieving high sensitivity and specificity of a diagnostic test requires a reliable and high quality sample. While traditionally blood was considered the preferred sample type for diagnostic applications, DNA from saliva is non-invasive and is now proven to be a viable and beneficial alternative. DNA from saliva improves patient care and convenience with point‑of-care sample collection while enabling efficient storage and transportation of stable samples at ambient temperature. DNA from saliva is reliably and easily collected using ORAcollect®•Dx. ORAcollect•Dx (OCD-100) is a device for the collection, stabilization and transportation of DNA from saliva and offers a non‑invasive, reliable method for collection of samples. A 510(k) validation study was performed to demonstrate the safety, effectiveness and robustness of the product.