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MDx/CDx Focus: Dako, Pfizer Collaborate on Companion Tests; New Study on MDxHealth's ConfirmMDx


Dako, Pfizer Ink Arrangement to Advance Companion Diagnostics

Agilent subsidiary Dako has inked an agreement with Pfizer to collaborate on multiple projects in the field of companion diagnostics.

The terms of the agreement cover "various collaboration projects" spanning research, development, commercialization, and advisory services related to companion tests.

John Hubbard, senior VP of development operations at Pfizer said in a statement that Dako will support Pfizer's efforts to advance precision medicine with help of companion diagnostics.

Pfizer received approval from the US Food and Drug Administration in 2011 for a personalized non-small cell lung cancer drug, Xalkori, which is indicated only for those patients with ALK-positive tumors. Pfizer worked with Abbott to develop an FDA-approved companion test that gauges which patients harbor ALK positive tumors (PGx Reporter 9/7/2011).

Pfizer has said that it is working on personalizing other drugs. Financial terms of the agreement were not disclosed.

Dako, purchased by Agilent for $2.2 billion last year, has a number of similar agreements with drug developers around companion diagnostics development. Dako has publicly announced companion diagnostic development deals with Genentech, Amgen, AstraZeneca, Bristol-Myers Squibb, and Eli Lilly.

New Study Backs Utility of MDxHealth's ConfirmMDx Prostate Cancer Test

Results from a study published in the March issue of the Journal of Urology showed that MDxHealth's ConfirmMDx test could accurately identify 64 percent of the prostate cancer-free men who could safely avoid a repeat biopsy with a negative predictive value of 90 percent.

The study, called MATLOC, also found that ConfirmMDX correctly identified 68 percent of men who had undetected prostate cancer when they had their last histopathologically negative biopsy. When these men had a repeat biopsy they found they had cancer that required aggressive treatment.

Currently the standard approach for prostate cancer detection is through a prostate biopsy, where healthcare providers collect ten to 12 needle core biopsy samples. However, this procedure samples less than 1 percent of the patient's prostate.

According to MDxHealth, ConfirmMDx is a test that detects an epigenetic "field effect" or "molecular halo" around a cancer lesion that can be present despite it appearing normal under a microscope. MDxHealth has launched the test as a tool to help urologists determine whether prostate cancer-free men can avoid biopsies and if high risk patients need repeat biopsies and aggressive treatment.

In the blinded, multicenter trial, researchers from the University of Edinburgh Urological Cancer Group and elsewhere analyzed 483 archived negative biopsy samples from men at high risk of prostate cancer with the ConfirmMDx assay, and compared the results to the detection rate according to repeat biopsies in those patients within 30 months.

"In a multivariate model, correcting for age, [prostate-specific antigen test], [digital rectal exam] and histopathological characteristics of the first biopsy, the ConfirmMDx assay proved to be the most significant, independent predictor of patient outcome with an odds ratio of 3.17 (95 percent confidence intervals) along with atypical cells in the first biopsy," MDxHealth said in a statement announcing the results from MATLOC.

With data from MATLOC, MDxHealth is hoping to market ConfirmMDx as a tool that urologists can use to more accurately diagnose prostate cancer patients. The company estimates that more than 650,000 men in the US receive a negative prostate biopsy result each year, but approximately 25 percent of them still have occult prostate cancer.