October 3, 2018
BOULDER, CO-ArcherDX, a molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine and Merck KGaA, Darmstadt, Germany, the vibrant science and technology company which operates its biopharmaceuticals business in the U.S. and Canada as EMD Serono, today announced that they have entered into an agreement to develop and commercialize a next-generation sequencing (NGS)-based companion diagnostic (CDx) test.
Under the terms of the agreement, ArcherDX, Inc. will develop and seek regulatory approval for a CDx test that will help physicians identify patients who may benefit from treatment with a Merck KGaA, Darmstadt, Germany drug candidate, by focusing on the detection of specific genomic alterations in plasma or formalin-fixed paraffin-embedded (FFPE) tissue samples. ArcherDX, Inc. will develop the CDx using the Archer® diagnostic platform, which combines the patented Anchored Multiplex PCR (AMP™) technology with the Illumina® MiSeqDx™ sequencing system and Archer® Analysis bioinformatics software. The CDx test will be designed to detect multiple classes of genomic alterations across a range of genes implicated in solid malignant neoplasms and is compatible with both FFPE tissue and plasma specimen types.
“We are pleased to launch this strategic companion diagnostic initiative,” stated Jason Myers, Ph.D., president and chief executive officer for ArcherDX. “The work we’ve engaged in with Merck KGaA, Darmstadt, Germany highlights the importance and potential of utilizing our proprietary profiling approach to make available to physicians an FDA-approved companion diagnostic solution for use with targeted therapies.”