Unleash the Power of Possibilities
Drug discovery in the era of precision medicine requires innovative and streamlined solutions to bring to market new treatments for patients that need them.
With over a decade of experience in molecular and multivariate assay development, we offer a suite of tissue-based and blood-based technologies to accelerate and de-risk your biomarker-driven clinical trials. These include a proprietary immuno-oncology platform, custom TMB panels, next generation sequencing (NGS), whole-exome sequencing services, RNA-seq, targeted PCR panels and more.
- Multiplex PCR assay and Real Time PCR IVD development
- Conversion of RNA expression signatures to targeted NGS or multivariate PCR assays
- Proprietary assays for immune therapy response prediction
- Core lab for IVD assay CDx support
- Replicate studies for IVD Diagnostic PMA or 510k submission
Identify and validate novel targets for clinically actionable diagnostics and therapeutics with our proprietary immuno-oncology assays, NGS subclassification panels, and broad tissue-based capabilities.
Assay Design, Development & Validation
Accelerate drug development and commercialization with our platform-agnostic approach that covers the spectrum from early-stage proof-of-concept tests through clinical trial assays, RUO tests and IVD offerings. Our laboratory, bioinformatics and biostatistics teams have discovered and developed multiple validated and marketed multivariate diagnostic tests.
Clinical Trial & Testing Services
Collaborate with our ISO- and CLIA-certified, CAP-accredited lab to process your clinical trial samples. Our lab has been qualified by multiple top-20 diagnostic and pharma companies for clinical trial testing, and we have supported a number of our partners with FDA and other regulatory submissions.
Biopharma Services Lab
- CLIA Certification (2013)
- CAP Accreditation (2016)
- ISO 9001 Certification (2015, est. 2013)
- Good Clinical Practice (GCP) Compliance (since 2017)
- Third-party quality assessed as supplier of genetic and specialized clinical Laboratory testing
- Incorporates 21 CFR 820 practices by adherence to design control protocols