Tag Archives: ArcherDx

June 30, 2020—Invitae and ArcherDX have entered into a definitive agreement under which the two companies will combine to create a cancer genetics and precision oncology company.

February 2020—ArcherDX announced a nonexclusive, multiyear partnership with Illumina intended to broaden access of next-generation-sequencing­–based oncology testing, including companion diagnostics for therapeutic selection, personalized monitoring, and recurrence surveillance IVD tests, upon FDA approval.  

February 2019—ArcherDx announced that the FDA granted a breakthrough device designation for its companion diagnostic assay application.

May 2018—ArcherDx and Ambry Genetics announced a partnership in which Ambry will provide biopharma sequencing services using ArcherDx’s next-generation sequencing assays. Ambry Genetics will utilize Archer Immunoverse and VariantPlex NGS assays to provide large-scale immune repertoire analysis and chimeric antigen receptor T-cell manufacturing characterization and pharmacodynamics to biopharma customers.

December 2017—ArcherDx has earned ISO 13485:2003 and EN ISO 13485:2012 certification from the British Standards Institution. This ISO certification indicates that the company’s quality management system maintains standards specific to medical devices, including in vitro diagnostic assays.

June 2017—ArcherDx and precision medicine company HeliTec (Shenzhen, China) announced a strategic partnership to advance NGS-based cancer diagnostic development in China. The partnership will entail co-developing and cross-licensing NGS-based technologies with the goal of registering oncology diagnostic kits with the Chinese Food and Drug Administration.

Under terms of an agreement with Illumina, ArcherDx will lead the development of a series of diagnostic tests, using ArcherDx’s Anchored Multiplex PCR chemistry, that will run on the Illumina MiSeqDx instrument.

June 2016—ArcherDX announced three targeted next-generation sequencing assays to capture and identify known and novel gene fusions, point mutations, and relative expression levels in myeloid and lymphoid origin malignancies. The Archer FusionPlex Blood Cancer panels use Archer’s proprietary Anchored Multiplex PCR to detect known and novel fusions from RNA.

March 2016—ArcherDX, in partnership with Horizon Discovery Group, launched the Archer SureShot ALK, RET, ROS1 Fusion Control to benchmark greater confidence in gene fusion detection using Archer FusionPlex Panels. The reference control is composed of FFPE curls of homogeneously mixed, precisely defined cell lines that contain EML4-ALK, CCDC6-RET, and SLC34A2-ROS1 fusions.