COMPANY:

Myriad Genetics

"Illumina...and Myriad Genetics...announced the expansion of a strategic partnership to broaden access to and availability of oncology homologous recombination deficiency (HRD) testing in the United States. Under the agreement, Illumina TruSight™ Oncology 500 HRD (TSO 500 HRD), a research-use-only test, is now available in the US. The expanded partnership also establishes a unique companion diagnostic (CDx) alliance for the pharmaceutical industry, which will enable more clinical research for gene-based, targeted therapies."

"Myriad Genetics, Inc...presented results from a longitudinal study validating RiskScore as a well-calibrated and more accurate predictor of breast cancer risk than a standard-of-care risk assessment alone. The data was shared in a spotlight discussion at the 2022 San Antonio Breast Cancer Symposium."

"Myriad Genetics...announced multiple presentations of new data at the 2022 San Antonio Breast Cancer Symposium (SABCS), including a spotlight discussion on breast cancer risk prediction....Spotlight discussion highlights how combined risk score may lead to improved breast cancer prevention and screening strategies....Additionally, there will also be poster session (P6-01-24) about an independent EndoPredict study....The study looked at prospective long-term outcome data with EndoPredict for women with early-stage breast cancer."

"Myriad Genetics, Inc...will spotlight efforts to expand access to prenatal and hereditary cancer genetic insights at the 41st Annual National Society of Genetic Counselors (NSGC) meeting, Nov. 16-19 in Nashville, Tenn...My Risk with Risk Score, Myriad’s market-leading hereditary cancer test that offers the first polygenic breast cancer risk assessment for women of all ancestries. RiskScore delivers a personalized 5-year and lifetime risk for developing breast cancer for women who qualify for MyRisk. JCO Precision Oncology recently published a study1 that highlights the development and validation of RiskScore for women of all ancestries. The study examined data from more than 275,000 women of diverse ancestral backgrounds to validate the use of ancestry-informative genetic markers. Results showed the new method was more accurate for women of all ancestries."

"Myriad Genetics, Inc...announced the launch of UroSuite, a comprehensive suite of genetic risk assessment tests that cover every stage of prostate cancer care....UroSuite includes Myriad’s Prolaris® Prostate Cancer Test, MyRisk™ Hereditary Cancer Test, BRACAnalysis CDx^® and Precise™ Tumor Molecular Profile Test. The combination of tests provides integrated genetic insights and makes it easier to tailor therapy and clinical trial selection for patients....'Today’s launch of UroSuite reinforces Myriad Genetics’ commitment to advancing health and well-being for all through a set of testing solutions for prostate cancer care, best-in-class support, and access to genetics and cancer specialists,' said Paul J. Diaz, president and CEO, Myriad Genetics."

P=Obs | N=855 | NCT04016935 | "Myriad Genetics, Inc...announced today Clinical Cancer Research, a journal of the American Association for Cancer Research, published a study 1 that shows the EndoPredict^® breast cancer prognostic test significantly predicted distant recurrence in premenopausal women with ER+, HER2- early-stage breast cancer....The study shows that patients with EndoPredict low-risk scores had a 97% distant recurrence free survival (DRFS) versus 76% for high-risk patients. Importantly, 19% of node-positive premenopausal patients had EndoPredict low-risk scores with 100% DRFS and were able to safely avoid chemotherapy and continue onto endocrine therapy alone....Another key result from an exploratory subgroup analysis within the study found similar DRFS rates in low-risk patients with or without ovarian function suppression (OFS), with less than 5% distant recurrence after 10 years in both groups."

"Myriad Genetics...announced Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted expanded coverage for the use of Myriad’s BRACAnalysis Diagnostic System as a companion diagnostic to identify patients with germline BRCA-mutated (gBRCAm) and HER2-negative high-risk recurrent breast cancer who may benefit from Lynparza (olaparib)."

"Clarified Precision Medicine said Wednesday that it is partnering with Myriad Genetics to make it easier for oncologists using Myriad's suite of cancer genetic tests to access expert interpretation of results through a newly formed molecular tumor board."

"Myriad Genetics, Inc...announced two partnerships with the Institut für Hämopathologie Hamburg (HPH) in Hamburg, Germany and the Centre Georges-Francois LeClerc (CGFL) in Dijon, France to expand access to MyChoice® CDx Plus testing. HPH and CGFL join Myriad’s network of partner laboratories to help support equitable patient access to genetic testing in key European markets."

"Myriad Genetics, Inc...announced a partnership with Epic, the industry leading healthcare software company, to integrate Myriad’s full line of genetic tests with Epic’s expansive network of 600,000 physicians and more than 250 million patients."

"Myriad Genetics, Inc...will present multiple studies at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, highlighting the value of genetic insights to guide and clarify cancer treatment and risk assessment...The presentations underscore Myriad’s commitment to partnering with oncologists and other healthcare partners to support health equity and provide data-driven insights to help guide clinical care and improve outcomes. They follow the recent launch of Precise™ Oncology Solutions, a comprehensive suite of solutions offering germline testing, tumor profiling, and companion diagnostic options, including evaluation for homologous recombination deficiency (HRD)."

Myriad Genetics, Inc...announced the expansion of its strategic partnership with Intermountain Precision Genomics, a service of Intermountain Healthcare, to add a new liquid biopsy therapy selection test to its growing oncology portfolio...The collaboration and platform established for Myriad’s recently launched Precise™ Tumor Molecular Profile Test leverages the strengths of Myriad’s hereditary cancer and companion diagnostic tests with Intermountain’s world-class laboratory services."

"Myriad Genetics, Inc...announced the launch of Precise™ Oncology Solutions, a comprehensive offering designed to help oncologists determine effective and personalized treatment plans for individual patients. The new suite provides physicians with streamlined testing that combines germline testing, tumor profiling and companion diagnostic options including evaluation for Homologous Recombination Deficiency (HRD), an important cancer repair pathway...Precise Oncology Solutions includes Myriad’s new Precise™ Tumor Molecular Profile Test, developed in collaboration with Intermountain Precision Genomics, leading healthcare providers, and industry partners."

"Myriad Genetics...announced the U.S. Food and Drug Administration (FDA) has approved Myriad’s BRACAnalysis® CDx test for use as a companion diagnostic to identify patients with germline BRCA-mutated (gRBCAm) HER2 negative, high-risk early-stage breast cancer who may benefit from Lynparza (olaparib)....BRACAnalysis CDx is intended to detect and interpret germline BRCA1 and BRCA2 variants. The test identifies deleterious or suspected deleterious germline BRCA variants in patients with HER2 negative high-risk early breast cancer."

"Myriad Genetics, Inc...two upcoming poster presentations at the 2021 San Antonio Breast Cancer Symposium (SABCS) that showcase the importance of genetic testing and precision medicine as integral components of both breast cancer treatment recommendations and risk assessment."

"Medical technology firm Noviscend said on Monday that it has signed an agreement to exclusively distribute certain of Myriad Genetics' genetic tests in Canada...According to Ontario-based Noviscend, the deal covers the EndoPredict breast cancer recurrence test; myRisk and myRisk – Hereditary and Single Gene Panel for hereditary cancer risk; myChoiceCDx test for homologous recombination deficiency status in ovarian cancer patients; the GeneSight pharmacogenomic test for patients with depression; and Prolaris for evaluating prostate cancer aggressiveness."

"Myriad Genetics, Inc...launched a new version of its market-leading MyRisk Hereditary Cancer Test. For the first time, women of all ancestries can now receive a personalized polygenic breast cancer risk assessment together with the market’s most accurate hereditary cancer test...MyRisk with RiskScore offers a breast cancer risk assessment designed to improve patient outcomes and help minimize healthcare disparities. RiskScore results are informed by a combination of genetic markers, clinical and biological variables, personal and family history, and ancestry-specific data. RiskScore is available at no additional cost to women who take the MyRisk test."

"Myriad Genetics, Inc...announced that it has completed the sale of its wholly-owned subsidiary, Myriad RBM, Inc. to Q2 Solutions...Myriad RBM, which specializes in laboratory services for clinical research for the pharmaceutical industry, will be added to the overall Q2 Solutions menu and offerings."

"PierianDx...today announced that it will work with existing partner, Intermountain Healthcare, to support Myriad Genetics’ comprehensive germline and somatic tumor testing service. The PierianDx support will enable Myriad to expand access to the highest quality somatic testing for patients in the U.S. and around the world. Somatic tumor tests performed using Intermountain Healthcare’s TheraMap® test will be analyzed and interpreted using the PierianDx Clinical Genomic Workspace™ and then combined with Myriad’s existing germline and companion diagnostic tests, providing a holistic and integrated view for all oncologists."

"On May 28, 2021, Myriad Genetics, Inc...completed the sale of its wholly-owned subsidiary, Myriad myPath, LLC, which owns the laboratory that offers the myPath Melanoma test, to Castle Biosciences, Inc for $32.5 million in cash."

"Myriad Genetics, Inc...today announced it has signed a definitive agreement to sell Myriad RBM, Inc. to Q2 Solutions...'The divestiture of Myriad RBM, along with other announced divestitures, allows us to accelerate the execution of our transformation plan and focus on advancing our core businesses in Women’s Health, Oncology and Mental Health.'"

"Castle Biosciences, Inc...today announced it has signed a definitive agreement to acquire all of the equity of Myriad myPath, LLC (Myriad myPath Laboratory), from Myriad Genetics. Myriad myPath Laboratory is a CLIA-certified laboratory in Salt Lake City, where the myPath Melanoma 23-gene expression profile (GEP) test was developed and is currently owned and offered. Castle is acquiring Myriad myPath Laboratory for $32.5 million. Castle will finance the acquisition price with cash and cash equivalents on hand. The transaction is expected to close approximately four weeks post signing, at which time Castle will be the successor owner of Myriad myPath Laboratory. The transaction is subject to customary conditions to closing."

"Biodesix, Inc...has announced their plan to add a blood-based 52-gene next generation sequencing (NGS) test to their portfolio of molecular testing based on a recent publication. Of critical importance, the publication, 'argeted Next-Generation Sequencing of Liquid Biopsy Samples from Patients with NSCLC,' in Diagnostics showed that the rapid liquid biopsy testing was able to detect actionable genomic alterations in patients with non-small cell lung cancer (NSCLC) with an unmatched turnaround time of only 72 hours."

"Myriad Genetics...announced that it has received additional reimbursement for its myChoice® Diagnostic System in Japan. The Myriad myChoice test is the most comprehensive tumor test for determining homologous recombination deficiency (HRD) status caused by a range of mutations in genes such as BRCA1 and BRCA2. It enables healthcare professionals to identify patients with advanced ovarian cancer who are eligible for first-line maintenance treatment with Lynparza (olaparib)."

"Myriad Genetics, Inc...today announced a new strategic precision oncology collaboration with Intermountain Precision Genomics, a service of Intermountain Healthcare. This collaboration creates a comprehensive germline genetic testing and somatic tumor offering that combines Myriad’s advanced hereditary cancer and companion diagnostic tests with Intermountain Precision Genomics’ world-class laboratory services, utilizing the TheraMap® test—powered by the TruSight™ Oncology 500 (TSO 500) next-generation sequencing test from Illumina, Inc. (NASDAQ: ILMN)."

Second Quarter Fiscal 2021 Financial Results Conference Call

"Myriad Genetics, Inc...announced today additional data further validating the prognostic power of its Prolaris® test and its ability to help accurately predict which men with more aggressive prostate cancer will benefit from intensification of therapy and which patients may safely avoid such treatments. This second validation study was presented during an oral presentation at the American Society of Clinical Oncology Genitourinary Cancer Symposium (ASCO-GU)..."

“Patients with Prostate or Pancreatic Cancer to Benefit from Treatment with Lynparza…In an announcement that will help more people with advanced prostate and pancreatic cancers in Japan, Myriad Genetics, Inc…will receive reimbursement for its BRACAnalysis® Diagnostic System, which helps physicians determine whether certain patients will qualify and potentially benefit from treatment with the PARP inhibitor, Lynparza (olaparib). BRACAnalysis was approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) in October 2020 as a companion diagnostic for these indications and the reimbursement decision is now in effect.”

"Myriad Genetics, Inc…today announced a strategic collaboration with Illumina, Inc…for Illumina to create a kit-based version of the myChoice® companion diagnostic (CDx) test for international markets...The strategic partnership with Myriad and Illumina consists of a time-limited exclusive agreement for Illumina to provide a kit-based version of the myChoice CDx test for international markets. Illumina will leverage its sequencing instrument install base and knowledge from increasing market adoption of its TruSight™ Oncology 500 next-generation sequencing assay to develop and commercialize distributed kits globally for the assessment of homologous recombination deficiency (HRD) along with other proprietary biomarkers while Myriad expands access and extends the reach of myChoice® CDx through Myriad’s services offering."

"With genetic sequencing at the forefront of precision medicine, Illumina...is pleased to announce a portfolio of new and expanded oncology partnerships that further the company’s commitment to develop standardized, globally distributable tools for precision oncology...Illumina is leveraging the content of its TSO 500 assay to develop companion diagnostics (CDx). The following partnerships demonstrate Illumina’s commitment to collaborating with industry leaders on cancer diagnostics and the advancement of precision oncology: BRISTOL MYERS SQUIBB...KURA ONCOLOGY...MYRIAD GENETICS...MERCK..."

"Myriad Genetics, Inc...announced today that it received its first reimbursement decision for the Myriad myChoice® Diagnostic System, which helps determine if women with ovarian cancer will benefit from the PARP inhibitor, Zejula® (niraparib)...Myriad has partnered with SRL Inc., a subsidiary of the H.U. Group Holdings, Inc., to commercialize the myChoice Diagnostic System in Japan."

"Myriad Genetics, Inc…announced today the expansion of Myriad myChoice® tumor testing in several European markets and China…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."

"Myriad Genetics, Inc…announced that the U.S. Food and Drug Administration (FDA) approved the BRACAnalysis CDx® test for use as a companion diagnostic by healthcare professionals to identify men with metastatic castration-resistant prostate cancer (mCRPC) who are eligible for treatment with Lynparza® (olaparib). Lynparza is approved for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone."

"Myriad Genetics, Inc…announced that the U.S. Food and Drug Administration (FDA) approved the myChoice CDx® test for use as a companion diagnostic by healthcare professionals to identify advanced ovarian cancer patients with positive homologous recombination deficiency (HRD) status, who are eligible or may become eligible, for first-line maintenance treatment with Lynparza (olaparib) in combination with bevacizumab."

“Myriad Genetics, Inc…announced that it has received reimbursement and launched the BRACAnalysis® Diagnostic System (i.e., ‘BRACAnalysis’) in Japan to help physicians determine which people affected with breast and ovarian cancer have Hereditary Breast and Ovarian Cancer (HBOC) syndrome and qualify for additional diagnostic and medical management…Myriad estimates that more than 25,000 people in Japan currently meet the testing criteria, and the company has partnered with SRL Inc., a subsidiary of Miraca Group, to commercialize the BRACAnalysis Diagnostic System in Japan.”

“Myriad Genetics, Inc…announced it has submitted a supplementary application with the Japanese Ministry of Health Labour and Welfare for its BRACAnalysis® Diagnostic System (i.e., ‘BRACAnalysis’) to be used as a companion diagnostic to help to identify people with metastatic pancreatic or metastatic castration-resistant prostate cancer who have germline BRCA1 and BRCA2 mutations and may be candidates for targeted therapy with the PARP inhibitor, Lynparza® (olaparib), subject to regulatory approval.”

“Myriad Genetics, Inc…announced that it has submitted a supplementary premarket approval (sPMA) application to the U.S. Food and Drug Administration (FDA) for its myChoice® CDx test to help identify women with advanced ovarian cancer who are potential candidates for maintenance therapy with Lynparza® (olaparib) in combination with bevacizumab. Myriad’s filing is based on the positive results from the Phase 3 PAOLA-1 trial of Lynparza...”

“Myriad Genetics, Inc….announced today that it has submitted a supplementary premarket approval (sPMA) application to the U.S. Food and Drug Administration (FDA) for its BRACAnalysis® CDx test as a companion diagnostic to AstraZeneca’s…and Merck’s PARP inhibitor Lynparza® (olaparib) for men with metastatic castration-resistant prostate cancer….Myriad’s filing for BRACAnalysis CDx is based on the positive clinical results from the PROfound study…”