On November 16, 2020 Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics and precision medicine,reported the expansion of Myriad myChoice tumor testing in several European markets and China (Press release, Myriad Genetics, NOV 16, 2020, View Source [SID1234571110]).

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Myriad myChoice CDx is the industry’s most clinically-validated genomic instability test. The test enables physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in potentially increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors, including Lynparza (olaparib). A biomarker subgroup analysis of the PAOLA-1 Phase III trial (Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer, 2019) of Lynparza included patients with advanced ovarian cancer and homologous recombination deficient (HRD)-positive tumors as detected by the myChoice test, including those with BRCA gene mutations. The trial showed that Lynparza in combination with bevacizumab maintenance treatment improved progression-free survival to a median of 37.2 months versus 17.7 months for bevacizumab alone in patients with HRD-positive advanced ovarian cancer. Recently, the European Commission authorized use of Lynparza for the first-line maintenance treatment with bevacizumab of patients with HRD-positive advanced ovarian cancer. Lynparza is jointly developed and commercialized by AstraZeneca (LSE/STO/Nasdaq: AZN) and Merck.

As part of the expansion in Europe, Myriad will license and provide technological support to leading pathology institutes in Germany and France. Additionally, Myriad will support European customers by performing testing out of its clinical laboratory at the company’s global headquarters in Salt Lake City. Also, the institutes in Europe will perform the tests with Myriad’s myChoice CDx PLUS assay. Myriad myChoice CDx PLUS is CE-marked in accordance with the In-Vitro Diagnostic Devices Directive (98/79/EC).

Another collaboration in China provides that Myriad will partner with Burning Rock Biotech, a leader in next generation sequencing technology for precision oncology, to provide myChoice for HRD testing in Phase III clinical studies and clinics throughout China. Myriad will provide Burning Rock with access to its proprietary myChoice technology. The partnership with Burning Rock expands global access to myChoice and positions the test as a preferred developmental companion diagnostic in this important drug development category.

"These new strategic partnerships with leading companies dedicated to advancing the power of precision medicine, reinforce Myriad’s commitment to expanding access to genetic insights for more patients than ever before," said Nicole Lambert, president of Myriad Genetic Laboratories. "Through close collaboration with innovative laboratories in Europe and with Burning Rock in China, we are bringing the clinical benefits of myChoice testing to additional markets and patients, advancing personalized treatment for patients around the world."

In August 2020, myChoice was exclusively cited and the only named commercial companion diagnostic by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in new recommendations on the use of PARP inhibitors for the treatment and management of certain patients with advanced ovarian cancer. The new recommendations, based on clinical trial results, were published in the Journal of Clinical Oncology.

About Myriad myChoice
Myriad myChoice is the most comprehensive homologous recombination deficiency (HRD) test, enabling physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice test comprises tumor sequencing of the BRCA1 and BRCA2 genes and a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions). For more information, visit: View Source