A moment years in the making and a giant leap forward in our mission to bring world-class precision oncology to patients and partners across the United States.
What This Moment Means to Us
There are milestones that mark progress on a spreadsheet, and then there are milestones that mark progress in people’s lives. Our CLIA certification of our Foster City, California laboratory falls firmly in the second category.
For our team, this certification is the culmination of years of relentless scientific work, rigorous quality standards, and an unwavering belief that the most advanced cancer diagnostics in the world should be available to every patient, every oncologist, and every clinical trial site, not just those at elite academic medical centres. Today, that belief has a new foundation to stand on.
What CLIA Certification Means
The Clinical Laboratory Improvement Amendments (CLIA) certification is the gold standard regulatory framework for clinical laboratory quality in the United States. Earning it means our Foster City laboratory has met the highest federal standards for accuracy, reliability, and quality across every aspect of our testing processes from sample collection and handling to analysis, reporting, and data management.
For our partners, our customers, and most importantly our patients, this certification is a guarantee a formal, government-backed assurance that the results generated in our laboratory meet the most rigorous clinical standards in the world.
The Science Behind the Certification
Our CLIA-certified laboratory is home to our OncoIncytes Cell Biopsy® suite- our comprehensive multi-modal cancer diagnostic platform that delivers simultaneous DNA, RNA, and protein analysis from just 20 mL of blood, at true single-cell resolution. Our 1,080-gene NGS panel has been independently validated at the Georgia Cancer Center’s GEM Lab under the leadership of Dr. Ravindra Kolhe, Professor and Chair of Pathology and a globally recognised authority in translational genomics, demonstrating 100% concordance with Illumina’s TSO 500 and the FDA-cleared PGDx panel across 15+ tumour types.
CLIA certification means this extraordinary science now meets extraordinary clinical standards, in a single, fully accredited laboratory.
What This Unlocks for Our Partners
For biopharma companies, academic institutions, and clinical trial investigators working with us, CLIA certification is the key that unlocks a new level of collaboration. Our Foster City laboratory is now positioned to support:
- Exploratory biomarker discovery for drug development programmes
- Patient stratification for clinical trials; including ADC and bispecific antibody studies
- Longitudinal disease monitoring across treatment cycles
- Multi-omic profiling of live CTCs with unmatched sensitivity and specificity
Sample collection kits can now be shipped directly from hospitals and clinical trial sites worldwide to our Foster City laboratory, with results delivered through our iDiscover platform with maximum accuracy and speed.
A Team Effort
This milestone belongs to every single member of our team -> our scientists, our bioinformaticians, our laboratory technicians, and our clinical and operations teams, who worked tirelessly to build a laboratory that doesn’t just meet the standard, but sets it. It also reflects the trust our clinical advisory board, our investors, and our partners have placed in us and the responsibility we feel to honour that trust every single day.
Our Commitment Remains Stronger Than Ever
CLIA certification is not a finish line, it is a launchpad. With our Foster City laboratory now fully certified, we are accelerating our engagement with biopharma and academic partners in the United States, expanding access to OncoIncytes, and moving closer to our vision of a world where precision oncology is no longer a privilege, but a standard of care for every patient, everywhere.
Investigators, sponsors, and research partners interested in collaborating with our CLIA-certified laboratory are encouraged to reach out at [email protected].