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


Barcelona, June 22, 2017 - Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), a leading global producer of plasma-derived medicines, and a leader in the development of innovative diagnostic solutions, is expanding its Texas-based Clinical Diagnostics Laboratory menu by launching therapeutic drug monitoring testing services.

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.