COMPANY:

Myriad Genetics

"Myriad Genetics, Inc...will hold its third quarter earnings conference call on Thursday, November 7, 2024 at 4:30 pm ET. The company’s quarterly earnings will be released the same day after the market closes. During the call, Myriad management will provide a financial overview and business update of the company’s performance for the third quarter 2024."

"Myriad Genetics Inc...announced a strategic partnership with jscreen™, a national organization that delivers education and access to preventative genetic testing with a focus on high-risk populations...The collaboration combines the strengths of Myriad’s high-quality hereditary cancer and reproductive genetics products, MyRisk® with RiskScore® and Foresight® - Carrier Screen, with jscreen’s trusted education and genetic care navigation program."

"Myriad Genetics, Inc...announced a collaboration with Flatiron Health...This collaboration allows physicians to order Myriad’s MyRisk® Hereditary Cancer Test and view the results of the test directly in Flatiron’s cloud-based Electronic Medical Record (EMR) platform, OncoEMR®. MyRisk is the first hereditary cancer test to be incorporated into Flatiron’s OncoEMR."

"Myriad Genetics, Inc...announced a series of ongoing research collaborations to study the use of molecular residual disease (MRD) testing in breast cancer using Myriad’s Precise® MRD test."

"Myriad Genetics, Inc...and Ultima Genomics, Inc...today announced a joint effort to explore Ultima’s UG 100 sequencing platform and its ppmSeq technology to advance Myriad’s ability to offer groundbreaking clinical tests. Myriad has purchased a new UG 100 that will soon join other leading sequencing platforms in its new Lab of the Future facility in South San Francisco...The low-cost and low-error sequencing achievable on the UG 100 may benefit several of Myriad’s emerging products that require large amounts of high-fidelity sequencing data....With Ultima’s support, Myriad will explore the potential for the Precise MRD test to improve in both performance and cost with ppmSeq on the UG 100. In the reproductive-health space, Myriad is expected to launch its FirstGene Multiple Prenatal Screen, which will run the content of multiple prenatal screens via a single sequencing workflow."

"Myriad Genetics...announced that the United States Patent and Trademark Office has issued a third patent that will strengthen its ability to deliver a tumor-informed, high-definition, molecular residual disease (MRD) assay to market. U.S. patent no. 12,104,212, entitled 'Personalized Methods for Detecting Circulating Tumor DNA,' demonstrates Myriad’s continued efforts to advance its MRD strategy on multiple fronts. The claims of the patent cover proprietary methods that generate ultra-sensitive detection of tumor-specific mutations in circulating tumor DNA (ctDNA)....Myriad continues to develop its Precise MRD assay to meet the needs of cancer patients, academic partners, and biopharma companies."

"Myriad Genetics, Inc...announced it will showcase 10 studies highlighting its advancements in oncology and reproductive genetic testing at the National Society of Genetic Counselors (NSGC) 43rd Annual Conference, which will take place from Sept. 17-21, 2024, in New Orleans, LA. The research will highlight the value of genetic and genomic testing in patient care and will cover the company’s MyRisk Hereditary Cancer Test, FirstGene Multiple Prenatal Screen, Prequel Prenatal Screen and Foresight Carrier Screen....Myriad will also have a virtual presentation, Characteristics and Cancer Incidence in MITF p.E318K Carriers, available for viewing on the NSGC online experience platform. This study shows that MITF carriers have an increased risk of melanoma, but not renal cancer, as several other studies have suggested."

"Eurobio Scientific...announces the finalisation of its agreement with Myriad Genetics to acquire the EndoPredict genomic test. As part of the agreement announced on 7 May 2024...on 1 August 2024 the Group has completed the acquisition of the second-generation genomic test EndoPredict for breast cancer and the license agreement to distribute the second-generation genomic test Prolaris for prostate cancer from Myriad Genetics. Revenues from these two activities are around €8m on an annual basis, with EBITDA levels in the short and medium term diluting the Group's performance."

"Myriad Genetics, Inc...announced that they have entered into an agreement to cross-license patent estates covering tumor-informed approaches to detect minimal residual disease (MRD). The agreement helps solidify each company’s freedom to operate in the MRD market and broadens patient access to the benefits of MRD testing."

"Myriad Genetics, Inc...announced that the United States Patent and Trademark Office has issued a second patent that will strengthen its ability to deliver a tumor-informed, high-definition, molecular residual disease (MRD) assay to market."

"Myriad Genetics, Inc...announced a collaboration with GSK aimed at improving access to homologous recombination deficiency (HRD) diagnostic testing for high-grade serous ovarian cancer (HGSOC) patients. A new sponsored testing program leveraging Myriad’s MyChoice HRD Plus and MyChoice CDx Plus Tests (collectively referred to as Myriad’s MyChoice Tests) is now available in Argentina, Brazil, Chile, Colombia, Egypt, Netherlands, Saudia Arabia, Singapore, and United Arab Emirates."

" Myriad Genetics, Inc...announced that Genetics in Medicine, an official journal of the American College of Medical Genetics and Genomics (ACMG), published a new study validating RiskScore®, Myriad’s breast cancer risk assessment tool integrated into its MyRisk® Hereditary Cancer Test. RiskScore combines a polygenic risk score (PRS) validated for all ancestries with the Tyrer-Cuzick model, a widely used breast cancer risk assessment calculator."

"QIAGEN...and Myriad Genetics...announced they will develop a globally distributable kit-based test for analyzing Homologous Recombination Deficiency (HRD) status. This next-generation sequencing (NGS) test aims to support research into personalized medicine in multiple solid tumor types, including ovarian cancer and is expected to enhance decentralized testing capacities once a regulated product is developed with pharmaceutical partners. The project builds on the recently announced master collaboration agreement between the two companies."

"Myriad Genetics...and its collaborators will share data from seven studies at the 2024 ASCO Annual Meeting. Three studies led by Myriad focus on breast cancer risk assessment, and four additional studies will be shared by collaborators that will cover the company’s Precise™ MRD Test, MyChoice® CDx HRD Companion Diagnostic Test, and the Myriad Collaborative Research Registry™ (MCRR)."

"Myriad Genetics...announced that JCO Precision Oncology has published a study showing a clinical cell-cycle risk (CCR) score can accurately predict the benefit of adding androgen deprivation therapy (ADT) to radiation therapy (RT) in men with localized prostate cancer."

"The UK National Institute for Health and Care Excellence (NICE)...recommended three prognostic gene expression tests as tools for guiding adjuvant chemotherapy treatment decisions in an expanded population of early breast cancer patients...In a final guidance, NICE said Myriad Genetics' EndoPredict (which is being sold to Eurobio), Veracyte's Prosigna, and Exact Sciences' Oncotype DX can be used within the National Health Service (NHS) to guide adjuvant treatment for postmenopausal women or men with estrogen receptor-positive, HER2-negative early breast cancer and one to three positive lymph nodes."

"Myriad Genetics, Inc...announced the reorganization of its European operations to better align company resources to its domestic opportunities while continuing to serve key biopharma partners and patients outside the United States."

"Leading commercial organizations and patient advocacy groups in the field of cancer genetics...announced the founding of the Inter-Organization Cancer Genetics Clinical Evidence Coalition (INTERACT), a coalition whose mission is to increase evidence-based access to genetic testing for people with or at risk of hereditary cancers...The coalition seeks to provide a collective voice in support of the progression of medical professional and industry guidelines for genetic testing for inherited mutations that increase cancer risk."

"Myriad Genetics...announced that the United States Patent and Trademark Office has issued a patent that will strengthen its ability to deliver a tumor-informed, high-definition, molecular residual disease (MRD) assay to market."

"Myriad Genetics, Inc...today announced a research collaboration with the National Cancer Center Hospital East (NCCHE) in Japan to study the prognostic and predictive value of molecular residual disease (MRD) testing. The SCRUM-MONSTAR-SCREEN-3 study will use Myriad’s ultra-sensitive MRD test, Precise MRD, to monitor circulating tumor DNA (ctDNA) over time in patients diagnosed with a wide array of solid tumor and hematological cancers...The SCRUM-MONSTAR-SCREEN-3 study, led by Dr. Takayuki Yoshino of the NCCHE, will explore how multi-omic profiling can be used to develop more personalized treatment and therapeutic strategies in three study cohorts."

"Myriad Genetics...announced it has completed the acquisition from Intermountain Health of select assets from its Intermountain Precision Genomics (IPG) laboratory business, including the Precise™ Tumor Test, the Precise Liquid Test, and IPG’s CLIA-certified laboratory in St. George, Utah."

"Myriad Genetics...announced it has entered into a definitive agreement to acquire select assets from Intermountain Precision Genomics’ (IPG) laboratory business, including the Precise™ Tumor Test, the Precise Liquid Test, and IPG’s CLIA-certified laboratory in St. George, Utah where the Precise Tumor Test is currently performed."

"Myriad Genetics...announced its support for the American Society of Clinical Oncology (ASCO)-Society of Surgical Oncology (SSO) guideline for germline testing in patients with breast cancer. The new guideline offers multi-pronged, evidence-based clinical practice recommendations. Among the guidance includes: (i) All patients with a current or previous diagnosis of invasive breast cancer ≤ 65 years should be offered BRCA1/2 testing; (ii) All patients with a current or previous diagnosis of invasive breast cancer > 65 years should be offered BRCA1/2 testing if personal or family history suggests the possibility of a pathogenic variant or are candidates for a PARP inhibitor therapy."

"Myriad Genetics, Inc...announced the launch of the Myriad Collaborative Research Registry (MCRR). Formerly known as the Precise Treatment Registry, the MCRR includes new data across germline and tumor testing results from Myriad’s cancer products on more than one million patients."

"Myriad Genetics, Inc...and Personalis, Inc...announced a non-exclusive collaboration through which Myriad will market the Personalis®ImmunoID NeXT ultra-comprehensive biomarker discovery platform to its pharmaceutical partners who use the MyRisk® Hereditary Cancer Test, BRACAnalysis CDx® and/or MyChoice® CDx cancer tests."

"QIAGEN...and Myriad Genetics...announced a new master collaboration agreement to develop companion diagnostic tests in the field of cancer...The partnership aims to deliver innovative services and products to pharmaceutical companies, enabling the development and commercialization of proprietary cancer tests for the U.S. clinical market, and providing distributable companion diagnostic test kits for the global market."

"Myriad Genetics, Inc...today announced two key milestones in its strategic partnership with Illumina Inc...to advance and support clinical research for gene-based, targeted therapies....Under the strategic partnership, Myriad and Illumina are working together to advance comprehensive genomic profiling plus homologous recombination deficiency (HRD) testing using the globally distributed Illumina TruSight Oncology 500 (TSO 500) assay, which enables comprehensive genomic profiling by analyzing 523 genes across DNA and RNA variants."

"Myriad Genetics, Inc...announced a collaboration with Memorial Sloan Kettering Cancer Center (MSK) to study the use of minimal residual disease (MRD) testing in breast cancer. The research project will use Myriad’s MRD testing platform, a tumor-informed high-definition assay that uses whole-genome sequencing to achieve high sensitivity and specificity for circulating tumor DNA (ctDNA)."

"Myriad Genetics, Inc...and Onsite Women’s Health, a leading national provider of breast health services...announced the launch of a new breast cancer risk assessment program to help more women understand their breast cancer risk."

"Myriad Genetics, Inc...announced the integration of Absolute Risk Reduction (ARR) into the Prolaris^® Prostate Cancer Prognostic Test to help patients and providers make personalized treatment decisions regarding hormone therapy. Prolaris is the only biomarker test to quantify the benefits of adding androgen deprivation therapy (ADT) to radiation therapy (RT)."

"Myriad Genetics, Inc...and Intermountain Precision Genomics, part of the Intermountain Health system, will begin providing oncology test results that allow access to the ComboMATCH trials. ComboMATCH is a coordinated platform of clinical oncology trials sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health."

"Myriad Genetics, Inc...announced its MyRisk^® Hereditary Cancer Test with RiskScore^® now incorporates breast density using Tyrer-Cuzick version 8 (TCv8) to provide patients and providers with a more comprehensive look at their five-year and remaining lifetime risk for breast cancer....The Federal Drug Administration recently updated mammography regulations requiring mammography facilities to notify patients about the density of their breasts by September 2024."

"Myriad Genetics, Inc...announced an agreement with The University of Texas MD Anderson Cancer Center to support research focused on metastatic renal cell carcinoma treatment selection and response. The project will use Myriad’s minimal residual disease (MRD) testing platform, a tumor-informed high-definition assay that detects circulating tumor DNA (ctDNA)....The research team will investigate the use of Myriad’s MRD testing platform as a non-invasive tool to inform treatment selection, surveillance, and radiotherapy treatment response in individuals with metastatic renal cell carcinoma (RCC)....The goal of this research is to determine if patients with RCC will benefit from a comprehensive genome-wide approach to MRD with this platform."

"Myriad Genetics, Inc...announced the addition of Folate Receptor Alpha (FRα) to its Precise Oncology Solutions portfolio. The new biomarker adds another companion diagnostic option for providers to help guide treatment decisions for patients with ovarian cancer."

"Myriad Genetics, Inc...and Intermountain Precision Genomics, a service of Intermountain Health, are now certified to offer solid tumor testing to patients in all 50 U.S. states after receiving the New York State Clinical Laboratory Permit."

"Myriad Genetics, Inc...and SimonMed Imaging, one of the largest independent outpatient medical imaging providers and physician radiology practices in the United States, today announced the planned launch of a new hereditary cancer assessment program that combines diagnostic imaging, genetic risk assessment utilizing MyRisk® with RiskScore® and patient education."

"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."