SALT LAKE CITY, May 28, 2015 (GLOBE NEWSWIRE) -- ARUP Laboratories, a leading national clinical and anatomic pathology reference laboratory and a leader in innovative laboratory research and development, and Labceutics (part of the Diaceutics Group), a global solutions provider to the pharmaceutical industry focused on optimizing the laboratory physician interface, announced today the formation of a unique strategic alliance to provide high-quality access to novel test development and commercial testing services for the pharmaceutical industry.
With 60–70 percent1 of pharma pipelines dependent upon companion or complementary diagnostics, there is an increasing need to ensure the parallel availability of high-quality novel tests that enable the right drug at the right time for the right patient. Through this strategic partnership, pharma teams will have early access to detailed planning, industry expertise, and implementation capability in one place.
During the past several years, ARUP Laboratories created a novel program called PharmaDx that would expand ARUP's business model to provide customized test development and validation services, as well as clinical research and commercial testing, to meet the unique requirements of the pharmaceutical industry. As a part of this endeavor, ARUP has developed and implemented an augmented quality management system, which meets FDA requirements for medical devices under 21 CFR part 820, for use on behalf of selected pharma-sponsored programs.
ARUP has entered into several collaborative agreements, spanning a variety of important disease areas, including oncology, infectious diseases, and multiple rare genetic disorders, with pharmaceutical companies. The company has demonstrated a number of important successes, including submission of clinical tests for FDA approval (pending), as well as the development of additional tests under its new design control program.
Novel diagnostics can take years to diffuse into laboratories serving prescribers in the United States. Labceutics early collaboration with Pharma teams to optimize access to companion and complementary diagnostics, partnered with ARUP Laboratories' unique model and reputation of providing the highest quality service to more than 20 percent of U.S. hospital laboratories will help accelerate access to the right test at the right time for pharma companies and their physician customers.
Physicians across the U.S. will have access to tests performed by their established laboratory, supplemented by ARUP's menu of novel emerging tests, with the added backing of ARUP's exceptional customer support and rapid access to the right test for the right patient.
"ARUP Laboratories is a major innovator in the field of laboratory medicine," said Sherrie L. Perkins, M.D., Ph.D. and Senior Vice President, Research & Development, ARUP Laboratories, "Our mission is to improve healthcare and advance the science of laboratory medicine through the development of new laboratory testing and technologies. With our Labceutics partnership, we will be providing specific solutions for the pharmaceutical industry with novel tests that support targeted therapy launches and ongoing clinical testing."
"Our work with leading pharma clients has taught us there is a critical need to improve the integration of the laboratory into pharma go-to-market planning and launches," said Julie Goonewardene, Chairwoman Diaceutics Group. "Since 2009, Labceutics has built a set of high-quality laboratory partnerships and laboratory to physician solutions across the globe to service pharma needs, but given the complexities of testing in the U.S., identifying the right partner took time and patience. Given ARUP Laboratories' unparalleled reputation and quality, that patience has been rewarded."
About ARUP Laboratories
Founded in 1984, ARUP Laboratories is a leading national reference laboratory and a non-profit enterprise of the University of Utah and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. ARUP serves clients across the United States, including many of the nation's top university teaching hospitals and children's hospitals, as well as multihospital groups, major commercial laboratories, group purchasing organizations, military and other government facilities, and major clinics. In addition, ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Clinical and Experimental Pathology®.
About Labceutics
Founded in 2009 as a division of the Diaceutics Group, Labceutics is the leading global Laboratory implementation provider to the pharmaceutical industry focused on personalized medicine. By working with laboratories "from the ground up," Labceutics creates accelerated, cost-effective, and lasting testing efficiency for personalized medicine. To date Labceutics has partnered with more than 260 leading laboratories in 26 countries.