UPPSALA, Sweden & PORTAGE, Mich.--(BUSINESS WIRE)--While novel protein-based therapies have shown great promise for combating diseases like cancer, AIDS, and arthritis, they also present new challenges in drug development. All biopharmaceuticals have a risk of generating an immune response. This immunogenicity has the potential to impact safety and efficacy of the biopharmaceutical. A crucial component of understanding the immunogenicity is to characterize the capacity of the antibody response to neutralize the biopharmaceutical activity and any endogenous counterparts, which could impact the efficacy and safety of the biopharmaceutical. The use of technology to identify the right patient groups has the potential to speed accurate diagnosis, decrease side effects, and increase the likelihood that a medicine will work for an individual patient.
As the world leader in specialty diagnostics for allergy and autoimmune diseases, Phadia is committed to providing innovative diagnostic tools to help improve patient care. Accordingly, today Phadia is announcing the introduction of new services to help the pharmaceutical industry maximize the safety and effectiveness of its biopharmaceutical drug development investments.
Immune Response Diagnostics from Phadia encompasses all three components of the ImmunoCAP® technology platform: the automated high throughput lab system family, the Multiplexing ImmunoCAP® ISAC technology, as well as the Point-of-Care technology ImmunoCAP® Rapid.
ImmunoCAP is the world’s leading allergy blood test and recognized as the gold standard in specific IgE antibody testing. The proven sensitivity and specificity of ImmunoCAP provides the ideal methodology to assess the likelihood of protein-based therapies to produce an immune response in patients.
With companion diagnostics, Phadia is providing drug development teams with the ability to tailor their therapies to identify and target specific patient groups in respiratory and autoimmune diseases. Phadia will work with its pharmaceutical industry partners to identify biomarkers and phenotypes present in patients who respond to drug therapy, and to develop tests that ensure these drugs are prescribed to patients where they will have the most significant clinical impact. Phadia’s global presence in more than three thousand laboratories around the world, its long regulatory experience, and its strictest commitment to the quality of its diagnostics makes it an invaluable partner for these therapeutic areas.
Hans Johansson, Vice President of Phadia AB and Head of Phadia’s Development Business says, “Phadia is the leader in providing cutting-edge technologies to identify the immune responses in allergies and autoimmune diseases in patients. Now, these technologies are being made available to help pharmaceutical companies identify the same type of immune responses to protein-based drug therapies.”
Mr. Johansson continued, “We have done significant development work with our partners in the pharmaceutical industry, and the early results are good. Our first application was to work with one of the world’s largest pharmaceutical companies to screen patients for a potential reaction to one of their drugs. This initiative demonstrated our technology has significant value and application beyond its use in the diagnosis of allergy and autoimmune disease.”
Immune Response Diagnostics is directly aligned with current trends in healthcare, including the use of more targeted therapies, personalized medicine, and evidence based medicine. The new initiative represents a return to its roots for Phadia, which was originally founded in 1971 as the diagnostics arm of Pharmacia, the Swedish pharmaceutical company. Since 2007 the company has been owned by Cinven, a leading European buyout firm.
David Esposito, President and General Manager of Phadia US Inc, concluded, “Ensuring market access to these innovative diagnostic tools is a critical component to realizing their full potential to improve patient outcomes while reducing the cost of care. The US Food and Drug Administration (FDA) is extremely interested in companion diagnostics, and we recognize the FDA’s importance in clearing a path for its widespread application to new drug development initiatives. We look forward to working with the FDA, the various healthcare payers, and our pharmaceutical partners to ensure physicians and patients have access to these important breakthroughs for improving care.”
About Phadia
Phadia is setting the standard as the world leader in specialty diagnostics for allergy and autoimmune related diseases. As the world leader in specialty diagnostics, Phadia is committed to providing innovative diagnostic tools to help better manage patients with suspected allergy or a suspected autoimmune disorder. ImmunoCAP Specific IgE is the world’s leading allergy blood test and the assay of choice among specialists. It is referenced and supported in over 3,000 scientific publications and in the most recently published Guidelines for the Diagnosis and Management of Food Allergy in the US. EliA® autoimmune assays are developed and optimized for Phadia® Laboratory Systems to provide exceptional sensitivity and specificity for the detection of disease-specific autoantibodies to aid in the diagnosis and management of autoimmune disorders. In addition to the introduction of cutting edge diagnostics tools to support the delivery of Immune Response Diagnostics, Phadia is developing and placing the benefits of ImmunoCAP® Molecular Allergy test results in every specialist’s hands to help improve the patient’s quality of life. Contact Phadia today at 800.346.4364 or go to www.phadia.com for Results You Can Trust.