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MDx/CDx Focus: NanoString Kicks off Second PAM50 Validation Study; MDxHealth Launches ConfirmMDx

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NanoString Launches Second Validation Study for PAM50

[This article has been updated from a previous version to correct details about NanoString's PAM50 test.]

NanoString Technologies this week announced the start of a second validation study for its PAM50 breast cancer prognostic assay involving 1,000 patient samples.

The study samples will come from patients enrolled in the Austrian Breast & Colorectal Cancer Study Group 8 trial, which was launched in 1996 to compare the efficacy and safety of tamoxifen as a single agent versus tamoxifen followed by anastrozole in post-menopausal, hormone receptor-positive early-stage breast cancer patients. The ABCSG8 trial showed that sequential adjuvant treatment with tamoxifen decreased recurrence rates in patients by 20 percent compared to treatment with just tamoxifen.

NanoString's retrospective validation study will assess how well the PAM50 test predicts whether patients in ABCSG8 are at high risk of recurrence. Michael Gnant of the Medical University of Vienna and president of the Austrian Breast & Colorectal Cancer Study Group is the lead investigator of the PAM50 validation study.

The PAM50 test operates on NanoString's nCounter platform. The test measures 50 classifier genes and five control genes and categorizes patients into four intrinsic breast cancer subtypes that confer prognostic information: luminal A, luminal B, HER2-enriched, and basal-like.

At the San Antonio Breast Cancer Symposium last year, NanoString presented results from the first clinical validation study involving the PAM50 test, which compared it against the market leader, Genomic Health's Oncotype DX breast cancer recurrence test. In the study, researchers led by Mitch Dowsett of the Royal Marsden Hospital analyzed 1,000 patient samples from the TransATAC trial and reported that the PAM50 prognostic score assigned 21 percent fewer estrogen-receptor-positive, node-negative breast patients to the intermediate risk group than did Oncotype DX, and deemed a portion of these patients to be at high risk of recurrence (PGx Reporter 12/14/2011).

NanoString said it is conducting these clinical validation studies in order to support the regulatory clearance of the PAM50 test.


MDxHealth Launches ConfirmMDx Epigenetic Test for Prostate Cancer Prognosis

MDxHealth this week launched ConfirmMDx Prostate Cancer, an epigenetic test that aims to help urologists confirm which patients have a true-negative prostate biopsy and which patients may have occult cancer and therefore need to repeat their biopsies.

“As many as one in four men could be misdiagnosed due to limitations with current prostate biopsy procedures, commonly described as ‘sampling error’. As a consequence, the standard of care for men with persistently high-risk factors, but no evidence of prostate cancer in a biopsy, is limited to continued surveillance and repeat biopsies, often on prostate-cancer-free men," Wim van Crienkinge, chief scientific officer of MDxHealth, said in a statement announcing the commercial launch of the test.

MDx Health believes that ConfirmMDx will address an unmet medical need in prostate cancer. The company estimates that more than 650,000 patients in the US have a negative prostate biopsy result each year, but between 25 percent and 35 percent of these tests are false negatives. Furthermore, despite collecting between 10 and 12 needle biopsy cores on average, healthcare providers end up only sampling less than 1 percent of a man's prostate. The gaps in the current standard of care result in the need for repeat biopsies in many men who are not at risk of cancer.

MDxHealth describes ConfirmMDx as a test that gauges "epigenetic changes associated with the presence or absence of prostate cancer." More specifically, the test detects the epigenetic field effect or “halo” in DNA of cells near cancerous lesions. "This molecular “halo” around a cancer lesion can be present despite having a normal appearance under the microscope," MDxHealth states on its website.

Patient samples will be analyzed at MDxHealth's CLIA-certified lab in Irvine, Calif. Physicians can submit samples directly to MDxHealth or to its marketing partner PLUS Diagnostics.

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