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 […]
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 lung cancer suspected of brain or central nervous system metastases |
| Oxford Gene Technology | SureSeq CLL + CNV Panel for cancer research |
| Genome Diagnostics | New version of NGSengine human leukocyte antigen typing software |
| Bio-Rad Laboratories | SEQuoia Complete Stranded RNA Library Prep Kit for RNA-Seq library preparation |
| OncoCyte | DetermaRx test for identifying early-stage lung cancer patients who may benefit from adjuvant chemotherapy after surgical resection |
| Illumina | New sequencing platforms NextSeq 1000 + NextSeq 2000 |
| Qiagen | QiaSymphony PowerFecal Pro DNA Kit for isolating microbial genomic DNA from stool + soil using QiaSymphony automation platform |
| Pillar Biosciences | Pillar Onco/Reveal Solid Tumor Panel, a 47-gene enrichment assay for research use |
| Personalis | NeXT Dx Test, NGS panel to help oncologists identify potential therapies + clinical trial options for cancer patients |
| Viracor Eurofins | Viracor TRAC donor-derived, cell-free DNA assay for diagnosing kidney transplant rejection |
| PreventionGenetics | Rapid PGxome whole-exome sequencing test |
| Sysmex | Japanese launch of Ipsogen JAK2 DX reagent |
| AMS Biotechnology | cfPure Max kit for circulating cell-free DNA purification |
| Lucid Diagnostics (PAVmed subsidiary) | subsidiary has launched its EsoGuard Esophageal DNA Test as |
| SpeeDx | European launch of ResistancePlus MG FleXible for GeneXpert System |
| Caris Life Sciences | MI GPS (Genomic Profiling Similarity) Score, AI product generating tumor type biology similarity score |
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