Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, and Scipher Medicine, a precision immunology company, today announced a multi-pronged collaboration designed to expand patient access to diagnostic services advancing precision medicine for rheumatoid arthritis (RA).

Under a multi-year collaboration, Quest will provide advanced RNA extraction and next-generation sequencing services for Scipher's PrismRA test. The test is a blood-based molecular signature response classifier (MSRC) aimed at predicting a patient's response to TNF inhibitor (TNFi) therapy, a commonly prescribed treatment for patients with RA. In addition, Quest will enable specimen collection at approximately 7,300 patient access points, including phlebotomists in physician offices and over 2,100 patient service center locations, as well as courier logistics services that include transport of patient specimens between the Quest and Scipher laboratories and provider sites.

RA is an autoimmune disorder affecting approximately 1.3 million people in the United States. While TNF inhibitors are first-line therapy for RA, one in three patients fail to achieve a favorable response, delaying treatment with alternative therapies.ⁱ Lack of prompt RA treatment is associated with worse outcomes, including irreversible joint damage, pain and disability. In addition, treatment with TNFi therapies for patients who will not benefit can contribute to wasted healthcare dollars, as this class of biologics can cost $10,000 to $30,000 a year.ⁱⁱ

"PrismRA is a breakthrough in RA precision medicine diagnostics because it helps enable the early, personalized treatment so critical to favorable outcomes for this often-disabling disease. Through our relationship with Scipher, Quest extends our capabilities in autoimmune diagnostic services, including services to aid clinical decisions with biologics," said Karthik Kuppusamy, Ph.D., Senior Vice President, Clinical Solutions, Quest Diagnostics.

Quest serves approximately one in two providers each year and enables connectivity with nearly 850 electronic health record systems for streamlined test ordering and results reporting.

The collaboration centers on Quest's next-generation sequencing capabilities at its advanced laboratory in Marlborough, Massachusetts. Quest will extract and sequence RNA from PrismRA blood specimens to identify approximately two dozen molecular traits associated with response to TNFi therapies. RNA transcripts in the blood can be incorporated into Scipher's molecular classifier analysis which is predictive of the biology that underpins drug response. Scipher will also incorporate this molecular data with patient data and results of anti-cyclic citrullinated peptide (anti-CCP), an RA antibody marker, from testing at its North Carolina laboratory. Through their electronic health record, physicians receive a personalized report with a score indicating predicted response based on analysis of the complete set of laboratory and patient data.

"Our collaboration with Scipher delivers on Quest's strategy and investments in genomics, particularly next-generation sequencing, and scale in blood-specimen logistics. With these differentiated assets, Quest is empowering clinical innovators like Scipher to fulfill the potential of precision medicine to benefit large, underserved patient populations," said Mark A. Gardner, Senior Vice President, Molecular Genomics and Oncology, Quest Diagnostics.

Testing with PrismRA
Scipher's PrismRA test analyzes RA patients' molecular profiles to identify those unlikely to respond to TNF inhibitors. By analyzing an individual's molecular signature, the PrismRA test helps identify patients who can be prescribed an alternative effective therapy to avoid unnecessary dose escalations or drug cycles.

Previous data published by Scipher indicates RA patients with moderate and high disease activity whose treatment was guided by PrismRA had a nearly two-fold clinical improvement in Clinical Disease Activity Index scores compared to patients whose therapy was not guided by PrismRA results over six months.ⁱⁱⁱ

"We are excited to work with Quest Diagnostics to provide patients access to our PrismRA test," said Scipher Medicine CEO Alif Saleh. "This relationship will significantly expand the availability and make an impact on patients suffering from RA."