QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a collaboration with SRL, Inc., the largest clinical testing laboratory company in Japan, to prepare for introduction of new companion diagnostics simultaneous with new drug approvals. The non-exclusive master collaboration agreement for clinical laboratory research services will enable rapid implementation by SRL of QIAGEN´s companion diagnostic workflows upon approval of the drugs and tests by Japan’s Pharmaceutical and Medical Devices Agency (PMDA). Several tests QIAGEN is co-developing with pharmaceutical partners are expected to enter registration in Japan in the coming years.
QIAGEN’s Day-One Lab Readiness initiative with SRL includes strategic planning for market access to companion diagnostics, filing for reimbursement, and alignment of medical communication by SRL, QIAGEN and pharmaceutical partners. The agreement will cover a range of QIAGEN companion diagnostics, including real-time polymerase chain reaction (PCR) and next-generation sequencing (NGS) solutions for Personalized Healthcare. Initial projects involve QIAGEN companion diagnostics paired with new drugs under development in Japan for solid tumors and leukemia.
“We are pleased to create this innovative program with SRL to close the time gap between new drug approvals and the availability of testing with companion diagnostics. Rapid implementation of personalized medicine solutions can benefit patients in many disease states, including cancer, with treatments guided by personalized genomic insights,” said Thierry Bernard, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN N.V. “Advance preparation by QIAGEN, our pharma partners and forward-thinking laboratories like SRL enable clinicians to quickly identify eligible patients and employ high-quality companion diagnostics for decision-making as soon as these promising new drugs are approved.”
Shunichi Higashi, President and Chief Executive Officer of SRL, said: “We are excited to partner with QIAGEN to provide new companion diagnostic tests to patients who have urgent need for testing. Through QIAGEN´s numerous companion diagnostic development and commercial collaborations with pharmaceutical companies, we expect a significant increase in commercial testing requests in the upcoming years. Working with QIAGEN will help us to meet these future testing requests in the most timely way for the benefit of patients and healthcare providers in Japan.”
QIAGEN, a global pioneer in Personalized Healthcare, markets a portfolio of about 30 companion diagnostics, which detect genetic abnormalities to provide insights that guide clinical decision-making. QIAGEN continues to expand its pipeline of solutions for precision medicine in cancer and other diseases, partnering with more than 25 pharmaceutical and biotechnology companies to co-develop companion and complementary diagnostics. Solutions span disease stages – screening, diagnostic, prognostic, predictive, and therapeutic and recurrence monitoring. QIAGEN’s pipeline draws on a full range of testing platforms: polymerase chain reaction (PCR) using QIAsymphony workflows, next-generation sequencing (NGS) with the GeneReader NGS System and universal solutions, and near-patient testing with QIAstat-Dx.
As QIAGEN collaborates with pharma and biotech partners, co-development progresses from drug discovery and creation of a biomarker test, to clinical development evaluating the proposed drug and test, to validation for clinical use and then commercialization of the new drug and companion diagnostic. Commercial alignment and launch readiness for companion diagnostics at the time of drug approval have become increasingly important for QIAGEN´s pharmaceutical partners. For more information, please visit https://www.qiagen.com/de/products/molecular-diagnostics/partnering-for-precision-diagnostics/.