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Dx Focus: Diagnovus Engauge-Cancer-DLBCL; Epigenomics Epi ProColon


Diagnovus this week launched Engauge-Cancer-DLBCL, a gene expression assay designed to aid physicians with risk stratification and treatment of patients with diffuse large B-cell lymphoma.

According to the company, Engauge-Cancer-DLBCL uses a proprietary algorithm that combines a two-gene signature (measuring expression of LMO2 and CD137) and the International Prognostic Index, producing a single risk classification. It is a standardized multi-gene reverse transcriptase-PCR assay conducted on paraffin-embedded primary DLBCL tumor tissue.

This test is performed in a CLIA-certified, CAP-accredited reference laboratory.

DLBCL is an aggressive tumor that can arise in virtually any part of the body. It is the most common sub-type of non-Hodgkin lymphoma, with an incidence of seven to eight cases per 100,000 people per year. Physicians currently assess a patient's DLBCL risk of disease progression and outcome by using the IPI, but more accurate classification of patients based on the underlying tumor biology is needed to allow physicians and patients to make more informed treatment decisions, Diagnovus said.

Engauge-Cancer-DLBCL "can more accurately predict outcomes for patients than IPI alone in order to optimize treatment choices for patients," Ron Levy, leader of the Lymphoma Program at Stanford University School of Medicine, said in a statement.

Epigenomics said this week that the US Food and Drug Administration has accepted a premarket approval application and granted priority review status for Epi ProColon, Epigenomics' colorectal cancer test.

EpiGenomics said that it filed the PMA in December after successfully completing a head-to-head comparative study with fecal immunochemical screening.

Epi ProColon is a CE-Marked nucleic acid amplification-based test to detect methylated DNA of the Septin 9 gene in patient plasma samples. Research has shown that Septin9 DNA is methylated in a vast majority of colon and rectal tumors, but not in normal cells.

Epigenomics previously licensed the Septin9 marker to Quest Diagnostics, which has incorporated it into its ColoVantage test.

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