The Canton-based company entered a strategic partnership with China-based laboratory services company KingMed Diagnostics, which will allow the companies to provide clinical trial needs at testing sites in China and Hong Kong. KingMed Diagnostics has a reach encompassing 37 laboratories covering more than 21,000 hospitals and clinics, according to the companies. Through the agreement, PGDx will provide its product, called elio, which tests more than 500 genes for alterations. The companies will also look to work toward regulatory approvals for the tests that it will allow the test to be used during routine clinical practice, said John Simmons, the Canton-based company’s director of translational science and diagnostics.
“PGDx is a leader in cancer genomics and I believe that by working together, we can accelerate the development of innovative diagnostic technologies in China and bring new hope to cancer patients,” Liang Yaoming, CEO of KingMed Diagnostics, said in a statement.
Separately, the company said the elio test will be used by pharmaceutical company Merck in a trial that will involve more than 70 clinical sites around the globe. The test is being used during the enrollment process for the analysis of tumor mutational burden, which is a measure of the number of mutations found in a tumor. Studies are exploring whether the biomarker can predict response to certain treatments.
PGDx is seeking expand its tests globally through a “kitted” approach that pairs wet lab and software functions. The idea is to provide the testing kits at local sites. The partnerships are part of the work to expand use of those kits, as the company seeks to show results and validate the products through trials, Simmons said.
“With the kitted approach for the PGDx elio portfolio, we aim to expand patient access to comprehensive, local genomic testing and reduce turn-around time for results that inform critical treatment decisions for patients worldwide,” PGDx CEO Doug Ward said in a statement.
Founded by Johns Hopkins cancer researchers, the company expanded in Baltimore by adding a second office in Canton last year. Simmons said the company’s product teams are designed to be roughly half wet lab–focused and half software–facing.