The DX Pipeline: OraSure Subsidiary’s DNA Test Sample Collection Kit Gets FDA Greenlight

On Jan 22, Ottawa-based DNA Genotek announced that it has obtained FDA 510(k) clearance for its Oragene Dx kits for collecting saliva samples for DNA testing. According to the company, Oragene Dx is now the first and only device with general clearance for collection and stabilization of DNA from saliva for use in genetic testing of human germline DNA, “including prescription or over-the-counter, direct-to-consumer use.” Collected samples The kits also allow for long-term storage of samples at room temperature. DNA Genotek is a wholly-owned subsidiary of OraSure Technologies since being acquired by the latter for $50.6 million in 2011. Other New DX Product Launches Here’s a rundown of the other key product launches announced from late December through late January. NEWLY LAUNCHED PRODUCTS & SERVICES Company(ies) Product(s)/Service(s) MGI One Million Genomes Total Solution, software + hardware solution combining sample preparation, high-throughput sequencing + data analysis for large-scale population genome sequencing projects Oxford Nanopore Technologies Flow cells using the R10.3 nanopore chemistry Congenica Congenica Neuro, new module for firm’s clinical decision support platform to help physicians characterize epilepsy + neurodevelopmental disorders Biocept Target Selector liquid biopsy assays detecting circulating tumor cells + biomarkers in cerebrospinal fluid of patients with breast or […]