Qiagen N.V.. (8/1/18). "Press Release: Qiagen Creates Collaboration with Japan’s Largest Clinical Laboratory Testing Company, SRL, to Accelerate Faunch of Companion Diagnostics". Hilden & Tokyo.

	Region	Japan
	Organisation	Qiagen GmbH
	Group	Qiagen (Group)
	Organisation 2	SRL Inc.
	Group	Miraca (Group)
	Product	companion diagnostic test
	Product 2	diagnostic services
	Index term	Miraca–Qiagen: molecular companion diagnostics, 201808– collab with SRL to introduce of CDx tests in Japan in line with respective drug approvals
	Person	Bernard, Thierry (Qiagen 201502– SVP Molecular Dx business area before bioMérieux Corp VP Commcercial Operations)
	Person 2	Higashi, Shunichi (Miraca 201808 CEO of Srl Inc)

Day-One Lab Readiness speeds commercialization and reimbursement in personalized medicine

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/.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of June 30, 2018, QIAGEN employed approximately 4,800 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

About SRL

SRL, Inc. offers clinical laboratory testing in every category, from general and emergency testing to esoteric and research testing, to support every aspect of modern medical care. SRL conducts more than 200,000 tests per day for hospitals and clinics across Japan, including 80 percent of Japan’s large hospitals. Through SRL’s main laboratories complex in Tokyo and more than 20 regional laboratories across Japan, SRL carries out analysis of specimens using advanced technological methods, proven quality assurance systems and accurate reporting on test results. Established in 1970, SRL is the clinical testing business of Miraca Holdings Inc. For more information, please visit https://www.miraca.com/en/group/business/clt.html or http://www.srl-group.co.jp/english/index.html.

Forward-Looking Statement

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

Record changed: 2023-06-05