Original from: Biocartis
Today, Biocartis, an innovative molecular diagnostics company, and Discovery Life Sciences (“Discovery”), a global leader in biomarker specialty laboratory services and biospecimen solutions, are pleased to announce a strategic collaboration to deliver seamless, end-to-end precision oncology solutions to pharmaceutical and biotech customers worldwide.
The collaboration pairs Discovery’s global clinical laboratory network and industry leading biorepository with the Idylla™ Platform, a fully automated, sample-to-result, real-time PCR (Polymerase Chain Reaction) based system that delivers in-house molecular biomarker results in only 3 hours, with more than 2,500 placements in over 95 countries. This collaboration expands access to ultra-fast biomarker testing, allowing pharmaceutical companies to rapidly identify and enroll patients in clinical trials.
The collaboration enables Discovery as a preferred testing laboratory, which includes joint companion diagnostic (CDx) and clinical trial assay (CTA) support, custom assay development, rapid access to prospective and banked biospecimens, biomarker discovery programs, and co-promotion to pharmaceutical partners. As a first priority, the companies will replicate their rapid KRAS testing program from Discovery’s Kassel, Germany location at their Newtown, PA, US facility.
Installing the Idylla™ Platform at both Kassel, Germany and Newtown, PA, US sites allows rapid molecular testing on both continents, giving global pharma programs harmonized results regardless of where samples are collected or tested. Discovery’s Kassel laboratory holds Health Institution status, which supports in-house device testing under Article 5(5) of the EU-IVDR. Using this approach, Discovery can move new biomarkers from project start to first patient sample in as little as six to seven months. Extending testing capability to the Newtown site gives sponsors a harmonized US and EU testing footprint and a faster path to companion diagnostic readiness to support global clinical trials.
“By combining Discovery’s biomarker expertise and specialty laboratory capabilities with the speed of the Idylla™ Platform, we can offer pharma partners a faster, more cost-effective path from sample to actionable biomarker insight”, said Anthony Green, EVP of Corporate & Business Development at Biocartis. “We are excited to build on our KRAS collaboration in Germany and bring this platform to the United States.”
“Pharma teams running global oncology trials face a real constraint. A biomarker result generated in Europe has to hold up against one generated in the US, or the data doesn’t translate. Installing Idylla™ at both Kassel and Newtown lets us run the same rapid assay on both continents and stand behind the comparability. That is what makes Newtown a genuine hub for this work, not just another testing site,” said T. Scott Reid, VP, Companion Diagnostics and Scientific Affairs at Discovery Life Sciences.
The companies will jointly develop curated pharma service bundles and cross-train their commercial and scientific teams to support a unified offering to pharmaceutical and biotech partners.
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