The diagnostic assay will be developed to detect the Denovo Genomic Marker 1 (DGM1) in Diffuse Large B-Cell Lymphoma (DLBCL) patients
Qiagen and Denovo Biopharma have collaborated to develop blood-based CDx test to treat DLBCL. (Credit: fernando zhiminaicela from Pixabay)
Qiagen has collaborated with Denovo Biopharma for the development of a blood-based companion diagnostic (CDx) test to treat diffuse large B-cell lymphoma (DLBCL).
Under the deal, the companies will develop a blood-based CDx test to detect patients expressing Denovo Genomic Marker 1 (DGM1) who are expected to respond to Denovo’s investigational cancer drug DB102 to treat common lymphoid cancer DLBCL.
Denovo’s drug, which is called enzastaurin, is a first-in-class investigational small molecule inhibitor of PKC-beta, a protein whose presence is mostly linked to DLBCL cases.
Qiagen oncology and precision diagnostics head and vice president Jonathan Arnold said: “We are proud to be at the cutting edge of precision medicine, a quantum leap from traditional one-drug-fits all medicine.
“Our molecular testing expertise will help Denovo to develop the use of the DGM1 marker with the DB102 drug for patients with DLBCL.”
Qiagen will involve in the development of a real-time qualitative PCR companion diagnostic for its Rotor-Gene Q MDx instrument.
The company will also apply an application to secure premarket approval (PMA) for the instrument from the US Food and Drug Administration (FDA).
Qiagen stated that it aims to secure the approval for the test simultaneously with Denovo receiving new drug application (NDA) approval for its DB102.
Currently, the drug and the DGM1 marker are in a phase III trial, called ENGINE, on newly diagnosed, high-risk DLBCL patients.
Denovo chief technology officer Xiao-Xiong Lu said: “As our ENGINE trial nears completion, we are pleased to be working with QIAGEN on commercial development of our DB102 programme to enable patients and physicians to potentially benefit from DB102 treatment.
“As a pioneer in precision medicine QIAGEN brings extensive experience in companion diagnostics, including ten FDA-approved tests.”
In November this year, Qiagen and DiaSorin have secured approval from the US FDA for use of QuantiFERON-TB Gold Plus assay on the automated LIAISON XS platform.