ResearchDx and Targeted Genomics are thrilled to announce that the GlutenID Celiac Genetic Health Risk Test has received FDA 510(k) clearance (K241456) with testing to be performed at ResearchDx’s PacificDx facility.
ISO 13485:2016 certified, CLIA approved, CAP accredited, FDA registered
Our experience includes developing biomarkers for dose selection, patient stratification, diagnosis, prognosis, and therapeutic response.
Supporting all test development, including PCR, qPCR, ddPCR, NGS, microRNA, protein, Flow cytometry, and ELISA.
GLP, GCLP, CLIA, NYS Validation. Orthogonal Testing services. Analytical and clinical performance verification
CLIA/CAP validations, Q-Subs, IRB submissions Class I,II,II device submissions and approvals MolDx submissions
ISO 13485 and GMP-compliant Kit Manufacturing. Pilot and small Batch Lots, Production Lots, Collection and shipping kits
Contract test commercialization. CLIA, CAP/ISO 15189 certification. FDA analytical and clinical validations. Orthogonal Testing
ResearchDx offers state-of-the-art custom and molecular assay development, from concept and biomarker discovery, through clinical validation and regulatory approval to final kit manufacturing.
ResearchDx solves the logistical complexities of multi-partner outsourcing for regulated companion diagnostic development. ResearchDx provides all expertise and services within a single, integrated organization.
Providing guidance for startups and industry-leading CLIA laboratories. Complete turnkey startup services, including CLIA, CAP, NYS, and ISO-15189 accreditation
Customized kit development, including diagnostic, analytical, and OEM assay, contract manufacturing ISO 13485:2016, and GMP compliance to meet your project needs
ResearchDx and Targeted Genomics are thrilled to announce that the GlutenID Celiac Genetic Health Risk Test has received FDA 510(k) clearance (K241456) with testing to be performed at ResearchDx’s PacificDx facility.
Prostatype Genomics receives CAP laboratory accreditation, achieves another milestone towards entering the US market for their groundbreaking Prostatype Gene Test
Heranova announces succesful CLIA certification and Early access launch of their groundbreaking HerResolve™, a Potential First FDA-Cleared, Non-Invasive Endometriosis Test
