PUBLIC HEALTH

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 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
CLOSE TO VIEW ARTICLE x

You have 3 articles left to view this month.

Your 3 Free Articles Per Month Goes Very Quickly!
Get a 3 month Premium Membership to
one of our G2 Newsletters today!

Click on one of the Newsletters below to sign up now and get unlimited access to all articles, archives, and tools for that specific newsletter!

Close

EMAIL ADDRESS


PASSWORD
EMAIL ADDRESS

FIRST NAME

LAST NAME

TITLE

COMPANY

PHONE

Try Premium Membership

(-00000g2)