Tag Archives: MDxHealth

October 2022—Mdxhealth has entered into a purchase agreement with Genomic Health, a subsidiary of Exact Sciences, to acquire Exact Sciences’ Oncotype DX Genomic Prostate Score test and most of the company’s team of urology sales and marketing professionals.

August 2019—MDxHealth announced that a second clinical validation study demonstrating the performance of its liquid biopsy test SelectMDx for prostate cancer has been published in the Journal of Urology (Haese A, et al. 2019;202[2]:256–263).

June 2019—Positive data demonstrating the clinical value of ConfirmMDx and SelectMDx (MDxHealth, Irvine, Calif.) for prostate cancer were presented in two moderated posters at the American Urological Association annual meeting, May 1–6 in Chicago.

December 2018—MDxHealth announced that the journal Urology Practice has published a study demonstrating the clinical utility of SelectMDx, a noninvasive liquid biopsy test to identify patients at increased risk of aggressive prostate cancer, in guiding initial prostate biopsy decision-making.

October 2018—MDxHealth announced that a study validating the cost-effectiveness of Select­MDx for Prostate Cancer has been published in Prostate Cancer and Prostatic Diseases. The study evaluates the potential cost-effectiveness of SelectMDx, a noninvasive liquid biopsy test to identify patients at increased risk of aggressive prostate cancer, in a population of men from France, Germany, Italy, and Spain with elevated prostate specific antigen.

Aug. 30, 2018—MDxHealth announced that a study validating the cost-effectiveness of SelectMDx for Prostate Cancer has been published in Prostate Cancer and Prostatic Diseases (Govers TM, et al. Epub ahead of print Aug. 20, 2018. doi:10.1038/s41391-018-0076-3). The study evaluates the potential cost-effectiveness of SelectMDx, a noninvasive liquid biopsy test to identify patients at increased risk of aggressive prostate cancer, in a ...

July 23, 2018—MDxHealth announced that Medicare administrative contractor Palmetto GBA has issued a positive final local coverage determination to expand Medicare coverage of the ConfirmMDx for Prostate Cancer test. The final LCD, which expands Medicare coverage to all providers, will be effective Sept. 3. The prior LCD, in 2014, limited coverage to only those providers enrolled in a certification and training ...

June 2018—MDxHealth announced that its ConfirmMDx is included in the 2018 European Association of Urology guidelines. Inclusion in the guidelines will facilitate adoption of the test in EU member state-specific guidelines, and the company will pursue CE marking of the test.

August 2017—MDxHealth has signed an exclusive licensing deal with Ghent University, Belgium, for its proprietary molecular diagnostic visualization technology that will allow the visual detection of epigenetic changes associated with cancer in tissue and liquid specimens.

July 2017—MDxHealth SA announced that results from a retrospective study demonstrated that its ConfirmMDx for Prostate Cancer test improved the identification of African American men at risk for aggressive cancer missed by a prostate biopsy. The study findings were presented in a podium session at the 2017 American Urological Association annual meeting in Boston.

March 2017—MDxHealth was awarded a U.S. General Services Administration supply contract to use ConfirmMDx for Prostate Cancer within the Department of Veterans Affairs.

June 2016—MDxHealth announced the commercial launch of its SelectMDx for Prostate Cancer test in the U.S. as a laboratory developed test. Testing will be conducted at MDxHealth’s CAP- and CLIA-accredited laboratory facilities in Irvine, Calif.

February 2016—MDxHealth announced that data demonstrating the clinical potential of its urine-based epigenetic bladder cancer test AssureMDx, to aid urologists in the management of patients presenting with hematuria, has been published in The Journal of Urology.

November 2015—MDxHealth announced the commercial launch of its noninvasive, urine-based test, SelectMDx for prostate cancer, in Europe via the company’s laboratory facilities in Nijmegen, the Netherlands.

July 2015—MDxHealth revealed data with the aim of demonstrating the prognostic value of its ConfirmMDx for Prostate Cancer test. The data, offered in two presentations at the American Urology Association’s annual meeting in May, show the test’s ability to identify patients likely to harbor clinically significant prostate cancer from negative biopsy tissue.

November 2014—The ConfirmMDx for Prostate Cancer test, from MDxHealth, qualifies for Medicare coverage effective Nov. 3, 2014. The Centers for Medicare and Medicaid Services released the final version of the coverage policy issued by Palmetto GBA: MoIDX title: ConfirmMDx Epigenetic Molecular Assay, LCD No.: L35368.

May 2014—Cancer test was used as part of a multidisciplinary approach to confirm prostate cancer diagnosis using a technique called transperineal mapping biopsy. The cancer lesions found using this method were not detected by five conventional biopsies.

MDxHealth announced data showing that methylation of the DCR1 gene may help guide oncologists in selecting metastatic colorectal cancer patients to receive irinotecan-based therapy. The data, presented at this year’s ASCO meeting, showed that CRC patients with methylated DCR1 did not benefit from the addition of irinotecan to capecitabine therapy.

MDxHealth has joined forces with Ghent University to establish NXTGNT, a pharmacoepigenomics center.