CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
February 2022—Qiagen and Denovo Biopharma will collaborate to develop a blood-based companion diagnostic test to identify patients expressing Denovo Genomic Marker 1 (DGM1) who are likely to respond to Denovo’s investigational cancer drug DB102 for treatment of diffuse large B-cell lymphoma. DB102 (enzastaurin) is an investigational small molecule inhibitor of PKC-beta, which, if present, has been linked to DLBCL cases.
Qiagen will develop a real-time qualitative PCR companion diagnostic for the Qiagen Rotor-Gene Q MDx instrument and apply for FDA premarket approval. The goal is to get the PMA for the test contemporaneously with Denovo receiving new drug application approval for its DB102. The drug and the DGM1 marker are currently in a phase three trial, called ENGINE, on newly diagnosed, high-risk DLBCL patients.