Clinical OMICS

JUL-AUG 2019

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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38 Clinical OMICs July/August 2019 www.clinicalomics.com M yriad Genetics cites its pioneering role in molecular diagnostics, with more than 20 years of experience dis- covering, developing, and delivering transformative molec- ular diagnostics to patients. The company's BRACAnalysis guides treatment deci- sions by analyzing the BRCA1 and BRCA2 genes to assess a woman's risk for developing breast and ovarian cancer. Other Myriad CDx offerings include Cell Cycle Prolifera- tion Assay, a proprietary element of Myriad's Prolaris test, which, with other clinical parameters, assesses prostate can- cer aggressiveness; and PREZEON, which assesses loss of PTEN function in cancer patients. "Myriad offers several advantages to help our pharmaceu- tical company partners succeed, including biomarker dis- covery, clinical research, regulatory and commercialization support," said Patrick Burke, Ph.D., executive vice president, emerging products, Myriad Genetics. "Myriad offers a menu of 'off-the-shelf' molecular diagnostic products that are com- mercially available to our pharmaceutical partners." In February, Myriad announced that its BRACAnalysis CDx successfully identified patients with metastatic pan- creatic cancer who have BRCA mutations and benefitted from treatment with AstraZeneca's Lynparza (olaparib) in the Phase III POLO trial (NCT02184195). Two months later, Myriad submitted to the FDA the first module of its PMA for its myChoice HRD CDx test, intended to identify patients with ovarian, fallopian, or primary peritoneal cancer who may benefit from Zejula (niraparib), marketed by Tesaro, a GSK (GlaxoSmithKline) company. Also in April, Myriad expanded its CDx collaboration with AstraZeneca and Merck & Co. The companies agreed to use BRACAnalysis CDx to identify germline BRCA muta- tions in men with metastatic castrate-resistant prostate can- cer (mCRPC) who are enrolled in the Phase III PROfound trial (NCT02987543). "In situations where a pharmaceutical company needs a custom assay of its own design, Myriad offers a simple and flexible fee-for-service protein biomarker assay platform to create partner-driven assays and test research hypotheses," Burke said. "Once a pharmaceutical partner 's clinical trials are completed, the Myriad regulatory team works to ensure FDA approval of companion diagnostics, while the compa- ny's commercial team helps support physician education, test adoption and our pharmaceutical partners' successful commercial launch." W hile Foundation Medicine has grown Roche's presence in companion diagnostics, the pharma giant's CDx activity is also being expanded through its Roche Diagnos- tics division. Roche Diagnostics finished 2018 with a 6.6% sales increase to CHF 12.879 billion ($12.892 billion), driven partially by a 9% jump in companion diagnostics, part of its Tissue Diagnostics business area. Roche doesn't further detail CDx results, but has said more about recent activity. Last year, Roche's cobas EGFR Muta- tion Test v2 won FDA approval as a companion diagnostic with AstraZeneca's Iressa (gefitinib) for first-line treatment of patients with non-small cell lung cancer (NSCLC). On April 23, Roche launched its VENTANA HER2 Dual ISH DNA Probe Cocktail same-day assay, designed to detect the HER2 biomarker in breast and gastric cancer patients who may be eligible for Herceptin (trastuzumab), marketed by Roche and its Genentech subsidiary. "As the market leader in diagnostics, we offer the larg- est number of placements across geographies, ensuring that patients have access to pivotal drugs as quickly as possi- ble," Christoph Majewski, vice president, companion diag- nostics, Roche Tissue Diagnostics, told Clinical OMICs. "Our medical teams work closely with pharma partners to pro- vide clinicians with education and training on new assays to ensure rapid access to groundbreaking treatments. Majewski noted that Roche Tissue Diagnostics was among the first companies to recognize this with the launch of the HER2 antibody to triage breast cancer patients for treatment with Herceptin. "In the 15 years since, Roche has gained deep experience in the development and launch of companion diagnostic assays. Roche Diagnostics has established an exemplary track record in supporting pharmaceutical companies in bringing new therapies to patients—collaborating with more than 70 partners on over 200 companion diagnostics," Majewski added. PATRICK BURKE Executive Vice President, Emerging Products CHRISTOPH MAJEWSKI Vice President, Companion Diagnostics

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