Merck announced that it has been selected by Swedish molecular diagnostics firm Elypta as the contract manufacturer for Elypta’s clinical diagnostic liquid biopsy kits. The kits analyze metabolites deregulated in several cancer types, making diagnoses more accurate.
“Both small and large diagnostic and clinical testing kit manufacturers struggle to find high quality, reliable contract manufacturing organizations like us,” said Jean-Charles Wirth, head of Applied Solutions, Life Science, at Merck. “The kits that we will produce together with Elypta use a bio-fluid sample to detect and analyze biological markers to evaluate disease and determine treatment options for cancer. This collaboration underscores our commitment to accelerate the pathway to commercialization of this important diagnostic product.”
The kits, which will be manufactured at Merck’s Life Science facility in St. Louis, Missouri, will initially be made available for research use only. They are intended for mass spectrometry systems and will allow qualified researchers to measure the full spectrum of human glycosaminoglycans in body fluid samples.
“Having Merck as a supplier helps us to commercialize Elypta’s test without significant manufacturing investments and will accelerate time to market,“ said Karin Mattsson, vice president of Research & Development at Elypta. “Merck’s history in IVD product custom manufacturing is well reflected in their current efforts with our kits and we have great confidence in their quality and manufacturing capabilities. We expect to have RUO kits ready for the market in 2020.”
Merck, which has more than 30 years’ experience in the diagnostics space, has been working with Elypta toward the customization of assay kits. Elypta plans to qualify the kits for in-vitro diagnostics use in the United States and European Union following completion of clinical validation studies, including one evaluating performance in surveillance of kidney cancer recurrence.