Archer Companion Diagnostic Co-Development Program
CDx Co-Development


ArcherDX combines superior targeted NGS technology with cGMP manufacturing and medical device quality standards to become the premium partner to help you develop, validate and commercialize in vitro diagnostic (IVD) tests such as companion diagnostic (CDx) tests.

Archer CDx co-development process

From conception to post-launch support, Archer will be your long-term partner in IVD development.

Archer CDx co-development process


Why team up with Archer

Development

  • Biomarker identification
  • Custom NGS panel development using superior targeted sequencing chemistry
  • FDA- and ISO 13485-compliant quality management system (QMS)

Manufacturing

  • Companion diagnostics (CDx)
  • Research Use Only (RUO) NGS assays
  • cGMP-capable facility
  • Extensive experience in NGS assay manufacturing
  • Scalable production

Regulatory

  • ISO 13485 certification for medical devices
  • Support for regulatory submission and approval inside and outside US for medical devices under FDA 21 CFR part 820 QSR and part 11 software

Global reach

ArcherDX distributes ArcherĀ® products worldwide to ensure global customer access.

 

Archer CDx pipeline

Archer CDx for Ignyta

Entrectinib - Archer is co-developing an IVD with Ignyta, Inc. to identify and enroll patients into the Phase-2 STARTRK-2 clinical trial for entrectinib, a tyrosine kinase inhibitor targeting NTRK1/2/3, ROS1 and ALK in solid tumors.

Archer CDx for Celgene

CC-122 - Archer is co-developing an IVD with Celgene to detect a proprietary gene signature to identify DLBCL patients that are most likely to respond to CC-122, a cereblon-modulating agent under investigation in multiple disease settings.


Read more about these partnerships

See the Archer CDx pipeline



Partner with Archer to co-develop your CDx or other IVD

If you have any technical questions, please reach out to our expert Technical Support staff through tech@archerdx.com or by calling ArcherDX directly at +1.303.357.9001.


How to contact us

Address

2477 55th Street, Suite 202

Boulder, CO 80301

Phone

Phone: (877) 771 1093

Phone: (303) 357 9001

All content © 2018 ArcherDX, Inc.

For Research Use Only. Not for use in diagnostic procedures. For Research Use Only. Not for use in diagnostic procedures.