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With Exclusive License to Marker, Empire to Launch Neuroendocrine Prostate Cancer Dx This Year

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Empire Genomics is working with researchers at Weill Cornell Medical College to develop a genetic test for neuroendocrine prostate cancer, a particularly deadly form of the disease about which little is known.

The oncology-focused molecular diagnostic firm is hoping to commercially launch the test later this year. In anticipation of that, Empire announced this week that it has acquired an exclusive license to a genomic marker associated with the disease from Cornell University.

Sonya Stutts, Empire's senior manager for marketing operations and quality systems, told PGx Reporter that the patent, which has yet to be granted by the US Patent & Trademark Office, will allow the company to develop a diagnostic test that gauges structural variations in the Aurora Kinase A gene, or AURKA. The marker "can be used in combination with other known and used prostate [cancer-linked] markers for increasing clinical utility of other assays," Stutts said.

After commercially launching the test, Empire is hoping to partner with drug developers that want to use the diagnostic to stratify patients in drug-development trials, the company said in a statement. Previously published studies by researchers from Weill Cornell suggest that an AURKA inhibitor could potentially be effective in patients with NEPC.

According to estimates, of the 34,000 patients who die in the US each year from prostate cancer, 25 percent may be due to NEPC. Neuroendocrine cells don't express androgen receptors or secrete prostate-specific antigen, so NEPC wouldn't be detected in screening tests. And because the disease shows up in late-stage prostate cancer patients, it has been difficult for researchers to study the disease at the molecular level.

NEPC can arise as the first instance of prostate cancer, but it can also show up in patients with prostate cancer adenocarcinomas after they've received hormone therapy that stops androgen hormones from reaching cancer cells. When it arises in late-stage prostate cancer patients, NEPC is lethal and quickly spreads to other organs, and patients with this specific form of prostate cancer usually survive for less than one year.

Currently, there are no therapeutic options for patients who have NEPC. By developing a test that can help better characterize the molecular features of the disease, Empire is hoping to inform novel treatment strategies.

Empire will develop the test with Mark Rubin, Himisha Beltran, and others at Weill Cornell. "This clinical tool will be important as we move forward with precision medicine clinical trials for aggressive castration-resistant prostate cancer led by Doctor Beltran," Rubin, director of the Institute for Precision Medicine at Weill Cornell, said in a statement.

Rubin has been involved in studies to identify molecular markers associated with NEPC. In January 2013, Juan Miguel Mosquera of Weill Cornell Cancer Center, Rubin, and others published a study that looked at whether abnormalities in AURKA and MYCN genes are associated with treatment-related NEPC in prostate cancer patients. The researchers analyzed primary prostate tissue samples from 15 hormone treatment naïve prostate cancer adenocarcinomas, 51 castration-resistant prostate cancers, and 15 metastatic tumors from 72 patients in different stages of treatment-related NEPC.

The study authors found that 65 percent of prostate cancer adenocarcinomas from patients who developed NEPC, including those treated with hormones and those who were treatment naive, had AURKA amplification. These same amplifications were also found in 86 percent of samples from those with metastatic disease. AURKA and MYCN were amplified in 70 percent of primary prostate cancer adenocarcinomas, 69 percent of treated adenocarcinomas, and 83 percent of metastatic tumors. Comparatively, when researchers looked for these markers in 169 patients with localized prostate cancer adenocarcinomas who underwent radical prostatectomy, AURKA and MYCN amplifications were identified in only 5 percent of the cases.

When Mosquera and colleagues compared metastatic treatment-related NEPC samples to primary prostate cancer adenocarcinomas from the same patients, they found 100 percent concordance of ERG rearrangement and AURKA amplification, and 60 percent concordance of MYCN amplification. For tumors that had mixed features, they reported there was similarly 100 percent concordance of ERG rearrangement, and "94 percent concordance of AURKA and co-amplification between areas of NEPC and adenocarcinoma."

Based on these results, the study authors concluded that "AURKA and MYCN amplifications may be prognostic and predictive biomarkers, as they are harbingers of tumors at risk of progressing to treatment-related NEPC after hormonal therapy."

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