The new CDx test will help to treat Diffuse Large B-Cell Lymphoma patients. Credit: Gabriel Caponetti / commons.wikimedia.org.

Qiagen has collaborated with Denovo Biopharma for the development of a companion diagnostic (CDx) test to identify Diffuse Large B-Cell Lymphoma (DLBCL) patients expressing a biomarker.

Under the terms of the deal, Qiagen will develop a new test that would be capable of detecting the Denovo Genomic Marker 1 (DGM1) in DLBCL patients.

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Discovered by Denovo, DGM1 predicts the responsiveness to the company’s investigational cancer drug DB102 to treat DLBCL.

DB102, which is also known as enzastaurin, is a small molecule inhibitor of the PKC-beta protein, which has been connected 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.”

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The company will develop a real-time qualitative polymerase chain reaction (PCR) CDx for use on its Rotor-Gene Q MDx instrument.

It will also seek the US Food and Drug Administration’s (FDA) premarket approval (PMA) for the new test.

The companies aim to obtain the PMA along with Denovo receiving approval for its new drug application (NDA) for DB102.

At present, the drug and biomarker are being evaluated in the Phase III ENGINE trial on high-risk DLBCL patients who are newly diagnosed.

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 CDx, including ten FDA-approved tests.”

Recently, Qiagen received CE mark for its QuantiFeron SARS-CoV-2 assay, which measures T-cell responses to Covid-19.