Grifols Continues to Strengthen its Diagnostic Division by Launching New Global Testing Services for the Measurement of Biological Drug Levels and Anti-Drug Immune Response in Blood Samples

As the standard of care changes towards individualized patient care in diseases such as inflammatory bowel diseases, the clinicians' demand for monitoring biologic drugs is growing. TDMonitor assays measure levels of infliximab (Remicade^®, Inflectra^®, Remsima^®), adalimumab (Humira^®) and vedolizumab (Entyvio^®) and the anti-drug antibodies. Test results support clinicians in making therapeutic decisions, improving patient therapy strategy and reducing the risk of debilitating disease progression.

TDMonitor assays were developed and validated by Grifols CLIA-certified Clinical Diagnostics Laboratory in San Marcos, Texas. Samples may be mailed to the laboratory from any country in the world. Following the testing of a sample, a complete report, which includes recommendations with references, is generated and then submitted to the healthcare provider within 5-7 days.

In May 2017, Grifols presented TDMonitor at Digestive Disease Week, a conference held in Chicago, Illinois. More than 14,000 gastroenterology professionals attended this year to review the newest technology innovations in gastroenterology.

Biologic therapy can result in varied responses in each patient. Factors such as inflammation, other drug therapies, genetic factors, disease phenotype, body mass, various immune responses and the presence of anti-drug antibodies can  influence responses, making monitoring of drug levels critical to patient care. The American Gastroenterological Association (AGA) has published a clinical decision support tool that indicates monitoring of responsiveness to therapy in patients with inflammatory bowel disease who do not remain in remission. See AGA Clinical Support Tool.  The AGA expects to publish a clinical practice guideline on Therapeutic Monitoring in Inflammatory Bowel Disease this summer. See AGA website.

"Grifols is driven to provide the healthcare community with vital diagnostics to support treatments of numerous, and many times, very rare, conditions. For more than 75 years, our company has pioneered and advanced biologic therapies. Our commitment remains strong, and this new blood testing service of biologic treatments is a testament to it," said Grifols Diagnostic Division President, Carsten Schroeder.

Grifols Clinical Diagnostics Laboratory plans to make available additional assays for new therapies later this year and in 2018.

For more information visit: Grifols Clinical Testing Services.

About Grifols Clinical Diagnostics Laboratory
Grifols Diagnostics Division operates testing laboratories, located in San Marcos, Texas. Focused on Specialty Diagnostics and Immunohematology, the laboratories offer high complexity testing in diverse disease areas to assist patient care, and a broad catalogue of specialized assays to support healthcare providers.

About Grifols
Grifols is a global healthcare company with more than a 75-year legacy of improving people's health and well-being through the development of protein therapies, hospital pharmacy products and diagnostic technology for clinical use.

The company is present in more than 100 countries worldwide, with headquarters located in Barcelona, Spain. Grifols is a leader in plasma collection with a network of more than 170 plasma donation centers in the U.S., and is a leading producer of plasma-derived medicines. As a recognized leader in transfusion medicine, Grifols offers a comprehensive range of transfusion medicine, hemostasis, and immunoassay solutions for clinical laboratories, blood banks, and transfusion centers.

In 2016, sales exceeded 4,000 million euros with approximately 15,000 employees. Grifols demonstrates its commitment to advancing healthcare by allocating a significant portion of its annual income to R&D.

The company's class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE: GRF). Its non-voting class B shares are listed on the Mercado Continuo (MCE: GRF.P) and on the U.S. NASDAQ via ADRs (NASDAQ: GRFS). For more information visit Grifols official website at www.grifols.com.

SOURCE Grifols

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