Quest Diagnostics, the world's leading provider of diagnostic information services, and the University of California, San Francisco (UCSF), the nation's leading university focused exclusively on health, have formed a collaboration to accelerate the translation of biomedical research into advanced diagnostics in the field of precision medicine, for improved patient care, treatment and outcomes. Initial clinical areas of focus include autism, oncology, neurology and women's health.

The collaboration, which combines the research discoveries and capabilities of UCSF with the national testing database and technical and clinical development capability of Quest Diagnostics, has an overarching aim of enabling holistic and integrated diagnostic solutions that close gaps in care or enable new clinical value.

Under the terms of the agreement, scientists will jointly research, develop and validate diagnostic innovations to solve specific clinical problems and provide actionable information to improve patient care. The organizations will focus on diagnostics to advance precision medicine, an emerging field of medical science that aims to integrate the most informative data from molecular, clinical, population and other research to create predictive, preventive and precise medical solutions for patients. Quest Diagnostics would independently develop and validate any lab-developed tests for clinical use that emerge from the collaboration's research.

Researchers will utilize laboratory-based diagnostics, imaging procedures and population analysis based on Quest's national Health Trends database, the largest private clinical database in the U.S., based on more than 1.5 billion patient encounters, to advance precision medicine.

The alliance is the first master agreement that UCSF's Office of Innovation, Technology and Alliances has signed with a clinical laboratory testing company and augments the university's efforts to translate laboratory research into new therapies. The broad agreement lays the groundwork for multiple projects between the two organizations.

"Advances in technology and science have identified many promising opportunities to improve outcomes through insights revealed by novel diagnostic solutions, yet fulfilling the full potential of these opportunities often hinges on translational clinical studies which validate their value," said Jay Wohlgemuth, M.D., senior vice president, Science and Innovation, Quest Diagnostics. "This unique collaboration between UCSF and Quest brings together the finest researchers and clinicians in the country to accelerate the development of a 'product pipeline' of scientific discoveries as clinically valuable diagnostic solutions that enable precision medicine for improved outcomes."

The collaboration is launching with two specific projects already underway. One project involves Quest's national database of molecular testing data to facilitate participation in research and development efforts related to genetic variations of autism, based on Quest's CGH microarray ClariSure™ technology, which can help identify genetic mutations associated with autism and other developmental disorders. While there currently is no treatment for autism, a test that aids its diagnosis could help identify individuals who might be appropriate candidates for research studies that could lead to future therapies.

The second project aims to identify biomarkers to determine which children with glioma brain tumors may benefit from a drug that is currently available to treat the disease. That project will integrate molecular biomarker testing with advanced MRI imaging technologies. This project is the first phase of larger collaborative studies to develop and validate integrated care pathways, which would include laboratory diagnostics, imaging data and other clinical information to be used in the management of patients with brain cancer and neurological diseases.

UCSF has been at the forefront of the movement toward precision medicine, for which former UCSF Chancellor Susan Desmond-Hellmann, MD, MPH, co-authored the initial National Academy of Sciences paper that defined the new field. That paper set the vision of harnessing the vast amounts of genetic, environmental and health data worldwide to make health care more predictive, precise and targeted.

"There are many diagnostics projects underway at UCSF for which Quest could partner and contribute a great deal of value in turning an isolated research project into a diagnostic service or other technology that directly benefits patients," said June Lee, MD, FACCP, director of Early Translational Research at the UCSF Clinical and Translational Science Institute, which initiated the collaboration with Quest after several scientists from both organizations had formed isolated, but successful, research collaborations. "This agreement will give UCSF researchers access to Quest expertise in developing diagnostics, as well as in understanding the market conditions for projects on campus."

The alliance will further combine UCSF's early-stage research with Quest Diagnostics expertise in data pooling and analysis to initiate and advance clinical studies. Strong areas of mutual interest include digital health initiatives to enhance the value of diagnostic information and inform population health strategies, and integrated diagnostics that will incorporate imaging, laboratory and clinical datasets into valuable diagnostic solutions that will yield health insights for targeted groups of patients.

"Quest's science and innovation strategy is focused on accelerating the introduction of clinically meaningful diagnostic solutions that aid the management of the individual patient across a continuum of care, promoting better outcomes," said Dr. Wohlgemuth. "UCSF's leadership in precision medicine and translational research makes it imminently well suited to help us advance this strategy, and we look forward to collaborating on new patient-centered precision diagnostics based on clinical, molecular and population research. A holistic approach to patient management - informed by diagnostic insights - will promote better decision making, more favorable outcomes and ultimately a healthier world."