COMPANY:

Roche

"Point32Health...and Foundation Medicine...entered into a value-based agreement to make FoundationOne®CDx and FoundationOne®Liquid CDx, FDA-approved comprehensive genomic profiling (CGP) tests, available to Point32Health members with advanced cancer, including Medicaid members."

"Roche...announced today the launch of the IDH1 R132H (MRQ-67) Rabbit Monoclonal Primary Antibody and the ATRX Rabbit Polyclonal Antibody to identify mutation status in patients diagnosed with brain cancer....The two tests are now available in the US. They will likely be available in other non-CE markets later this year and in countries that accept the CE mark in 2024."

"Foundation Medicine, Inc...announced today that UnitedHealthcare commercial plans will cover FoundationOne^®CDx as a companion diagnostic in all solid tumors for patients with unresectable or metastatic cancer being considered for treatment with an immune checkpoint inhibitor and meeting coverage criteria. Additionally, FoundationOne^®Liquid CDx will be covered as a companion diagnostic for patients with advanced breast cancer, metastatic non-small cell lung cancer (NSCLC), recurrent ovarian cancer and metastatic castrate-resistant prostate cancer (mCRPC) meeting coverage criteria. Coverage is effective April 1, 2023....UnitedHealthcare’s planned coverage of FoundationOne CDx and FoundationOne Liquid CDx is in addition to coverage that Foundation Medicine already has for these tests from other national and regional commercial providers, as well as by Medicare and Medicare Advantage plans."

"Foundation Medicine, Inc...announced a global collaboration with Boehringer Ingelheim to develop the company’s tissue-based comprehensive genomic profiling test, FoundationOne^®CDx, as a companion diagnostic for Boehringer Ingelheim’s investigational MDM2-p53 antagonist, BI 907828, in the United States, Japan and European Union."

"Today Foundation Medicine, Inc...announced a global collaboration with Karyopharm Therapeutics Inc. to develop FoundationOne^®CDx as a companion diagnostic for selinexor, which is being evaluated as a front-line maintenance therapy following systemic therapy in patients with advanced or recurrent TP53 wild-type endometrial cancer."

"Foundation Medicine, Inc and Natera...launched an early access program for clinical use of FoundationOne^®Tracker, a personalized circulating tumor DNA (ctDNA) monitoring assay. In addition, the investigational use only version of the test is now available for use in clinical trials...FoundationOne Tracker is now available through an early access program to a limited number of clinical customers, with plans to expand for broad availability in the United States later in 2023."

"Foundation Medicine, Inc...announced that the U.S. Food and Drug Administration (FDA) has approved FoundationOne®Liquid CDx to be used as a companion diagnostic to identify patients with ROS1-positive non-small cell lung cancer (NSCLC), or patients with NTRK fusion-positive solid tumors, who do not have a tissue sample available and may be appropriate for treatment with Rozlytrek (entrectinib), a targeted therapy developed by Genentech, a member of the Roche Group."

"Foundation Medicine, Inc...announced that the U.S. Food and Drug Administration (FDA) has approved its FoundationOne^®Liquid CDx as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitutions and are appropriate for treatment with a group of current and future EGFR tyrosine kinase inhibitors (TKI) approved by the FDA for this indication."

"Roche...announced US Food and Drug Administration (FDA) approval of the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the first immunohistochemistry (IHC) companion diagnostic test to aid in identifying epithelial ovarian cancer (EOC) patients who are eligible for targeted treatment with ELAHERE™ (mirvetuximab soravtansine-gynx)....Developed as a predictive biomarker, the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay detects the folate receptor 1 protein (FOLR1 or FRɑ), which is over-expressed in most ovarian cancers. The new test identifies ovarian cancer patients eligible for targeted treatment with ELAHERE....The approval is based on the results of the SORAYA clinical study."

"Positive data on cevostamab will be presented at ASH, including data from the phase I GO39775 study, which suggest that patients with heavily pre-treated multiple myeloma can maintain durable responses with fixed-duration cevostamab. Additionally, phase I data from Roche’s GPRC5DxCD3 T-cell engaging bispecific antibody, RG6234, showing encouraging preliminary activity in people with R/R multiple myeloma, will be presented."

"Roche...announced the launch of Anti-PRAME (EPR 20330) Rabbit Monoclonal Primary Antibody to identify PRAME protein expression in tissue samples from patients with suspected melanoma. Because the PRAME (PReferentially expressed Antigen in MElanoma) protein is expressed in most melanomas, the PRAME (EPR20330) Antibody* is used as an aid to differentiate between benign and malignant lesions to help improve diagnostic decisions. If PRAME expression is detected, this suggests that the lesion is malignant."

"Roche...today that the US Food and Drug Administration (FDA) approved the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify metastatic breast cancer patients with low HER2 expression for whom ENHERTU (fam-trastuzumab deruxtecan-nxki) may be considered as a targeted treatment....The FDA approval of the new HER2 low indication expands on the intended use for Roche’s proven, on-market PATHWAY anti-HER2 (4B5) test, delivering timely, clear and confident results. The launch exemplifies Roche’s commitment to continuing to innovate integrated, high medical value solutions that help to advance personalised healthcare."

"Foundation Medicine, Inc...today announced a collaboration to develop FoundationOne®CDx as a companion diagnostic for Day One’s lead investigational therapy, tovorafenib (DAY101)...Tovorafenib is an investigational, oral, brain-penetrant, highly selective type II pan-RAF kinase inhibitor, which is currentlybeing evaluated in an ongoing pivotal Phase 2 clinical trial (FIREFLY-1) for the treatment of pediatric, adolescent and young adult patients with relapsed pediatric low-grade glioma (pLGG)."

"Roche today announced that it has signed a Memorandum of Understanding (MoU) with the Johns Hopkins Program for International Education in Gynecology and Obstetrics (Jhpiego) to improve cervical and breast cancer outcomes in resource-constrained countries...In the new partnership, Roche and Jhpiego will prioritise low- and middle-income countries in Africa and Asia, where the burden of breast and cervical cancers is highest. The initiative will take a multi-pronged approach to increase access to diagnostics and treatment."

"Today Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, and Relay Therapeutics (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, announced a collaboration to develop FoundationOne^®CDx as a companion diagnostic for RLY-4008, the company’s investigational FGFR2 inhibitor....If the therapy and companion diagnostic are approved, FoundationOne CDx would be used to identify patients with FGFR2 fusions and select rearrangements in CCA who may be appropriate for treatment with RLY-4008."

"The VENTANA PD-L1 (SP263) Assay helps determine which patients with non-small cell lung cancer may be eligible for treatment with Libtayo monotherapy1 based on the results of the Phase III EMPOWER-Lung 1 study. This additional approval will allow more patients with locally advanced and metastatic non-small cell lung cancer broader access to the immunotherapy Libtayo."

"Two studies leveraging Foundation Medicine’s novel homologous recombination deficiency signature (HRDsig) to explore whether this biomarker is associated with FOLFIRINOX benefit in patients with metastatic pancreatic cancer via the Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB), and to understand the prevalence of HRDsig positivity in non-small cell lung cancer using FoundationOne^®CDx....A real-world analysis of 447 men in the CGDB with de novo metastatic prostate cancer treated in standard of care settings, found that the subgroup with SPOP mutations had much more favorable time to castration resistance and overall survival if treated with second generation hormonal agents versus docetaxel. Another study using Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) test found that SPOP mutations occur in a moderate number of Clinically Advanced Prostate Cancer (CAPC) cases..."

"Roche...announced CE label expansion of the VENTANA PD-L1 (SP263) Assay in non-small cell lung cancer (NSCLC) as a companion diagnostic for Tecentriq (atezolizumab). This advances the company's commitment to guide clinical decision making through innovative, high quality assays that improve patient access to personalised healthcare....The VENTANA PD-L1 (SP263) Assay was used in the IMpower010 study sponsored by Genentech, a member of the Roche Group, to identify patients whose tumours expressed the PD-L1 protein."

"Roche...today announced the launch of the Digital LightCyclerⓇ System, Roche’s first digital polymerase chain reaction ( PCR) system. This next-generation system detects disease and is designed to accurately quantify trace amounts of specific DNA and RNA targets not typically detectable by conventional PCR methods....The Digital LightCycler System will allow clinical researchers to divide DNA and RNA from an already extracted clinical sample into as many as 100,000 microscopic individual reactions. The system can then perform PCR and produce highly sophisticated data analysis on the results."

"Amoy Diagnostics and Roche Pharma China reached a strategic cooperation to jointly promote the development of an open, cooperative and innovative medical and health ecosystem and provide patients with more accurate digital medical solutions. This coupled with the July 29th approval of Roche’s Rozlytrek (Entrectinib, a selective tyrosine kinase inhibitor to treat patients with NTRK-fusions positive solid tumours) in China will allow both companies to work jointly to establish a precise and treatment path and maximize the benefits for NTRK-fusion positive patients."

"Roche...announced US Food and Drug Administration (FDA) approval of a label expansion for the VENTANA MMR RxDx Panel. This approval advances the company's commitment to personalised healthcare through tests that determine which patients are most likely to respond to specific and targeted therapies....FDA approval of the label expansion for the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated panel of MMR biomarkers tested by IHC. This label expansion follows the April 2021 FDA approval of the VENTANA MMR RxDx Panel as the first IHC predictive test to identify endometrial carcinoma patients eligible for treatment with the anti-PD1 immunotherapy JEMPERLI (dostarlimab-gxly)."

P4 | N=1,000 | NCT04180176 | Sponsor: Genentech, Inc. | "Foundation Medicine, Inc., Flatiron Health, and Genentech, members of the Roche Group, in partnership with a network of community oncology practices, today announced new research in the Journal of Thoracic Oncology Clinical and Research Reports on tumor profiling results from the ongoing, multicenter Prospective Clinicogenomic (PCG) Study (NCT04180176)....At study enrollment, patients with non-squamous aNSCLC received Foundation Medicine’s liquid biopsy CGP testing, and a subset also received Foundation Medicine tissue testing. Results demonstrate that tissue-based FoundationOne®CDx and blood-based FoundationOne®Liquid CDx both provided superior biomarker detection over more limited tissue testing of up to 5 biomarkers. In particular, Foundation Medicine's liquid biopsy test detected guideline-recommended biomarkers in 48 additional patients who received single biomarker or hotspot testing."

"Medial EarlySign...announced today the signing of a new partnership with Roche, which will focus on innovative, evidence-based solutions for early detection of lung cancer...The goal of this new collaborative effort is to deliver validated clinical machine learning models to advance lung cancer identification which can lead to earlier diagnosis and treatment. Early identification of high-risk individuals has the potential to improve lung cancer survival rates by finding the disease at an earlier stage when it is more likely to be curable."

"Roche...announced the launch of the BenchMark ULTRA PLUS system, its newest advanced tissue staining platform. The system enables quick and accurate test results so clinicians can make timely decisions regarding a patient’s care journey...The new BenchMark ULTRA PLUS system continues the evolution of the BenchMark series, which revolutionised cancer diagnostics by fully automating processes that used to be performed manually, one slide at a time."

"Roche...announced the CE launch of the next-generation VENTANA DP 600 slide scanner (CE-IVD marked). This high-capacity slide scanner produces excellent image quality of stained histology slides from patient tissue samples, while providing ease-of-use and workflow flexibility for the pathology lab."

"Roche...announced the launch of a human papillomavirus (HPV) self sampling solution in countries accepting the CE mark. This new solution enables a patient to privately collect her sample for HPV screening while at a healthcare facility, following instructions provided by a healthcare worker. The clinically-validated vaginal sample is analysed with the Roche cobas® HPV test on a Roche molecular instrument."

"Roche...announced that the United States Food and Drug Administration (U.S. FDA) has approved Foundation Medicine’s FoundationOne®CDx as a companion diagnostic (CDx) for Roche’s Rozlytrek® (entrectinib)....It is the first and only U.S. FDA-approved CDx to identify patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC), or patients with NTRK fusion-positive cancers, for whom treatment with Rozlytrek may be appropriate....The approval is based on data from the phase I ALKA-372-001 (EudraCT 2012-000148-88), phase I STARTRK-1 (NCT02097810) and phase II STARKTRK-2 (NCT02568267) trials."

"Today Foundation Medicine, Inc...announced a collaboration with Arvinas, Inc., to develop FoundationOne®Liquid CDx as a companion diagnostic for use with Arvinas’ bavdegalutamide (ARV-110), an investigational novel PROTAC® protein degrader targeting the androgen receptor (AR). Arvinas’ bavdegalutamide is being developed for the potential treatment of men with metastatic castration resistant prostate cancer (mCRPC) who have progressed on existing therapies."

"Foundation Medicine, Inc...announced its participation in a neoadjuvant screening trial in partnership with the Lung Cancer Research Foundation (LCRF) and Lung Cancer Mutation Consortium (LCMC). This screening trial, entitled 'LCMC4 Evaluation of Actionable Drivers in EaRly Stage Lung Cancer' (LEADER), is the fourth study conducted through the LCMC and is a collaborative effort involving numerous academic study sites and pharmaceutical supporters. Foundation Medicine will be the sole provider of comprehensive genomic profiling (CGP) in the LEADER trial, which will utilize both of Foundation Medicine’s FDA-approved CGP tests: the tissue-based FoundationOne®CDx and the blood-based FoundationOne®Liquid CDx."

"Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) on June 2, 2022, for FoundationOne ®CDx Cancer Genomic Profile to be used as a companion diagnostic (CDx) for non-small cell lung cancer (NSCLC) therapies, a tyrosine kinase inhibitor VIZIMPRO® tablets (generic name: dacomitinib hydrate) and a tyrosine kinase inhibitor ALUNBRIG® tablets (generic name: brigatinib), as well as for malignant melanoma therapies, a BRAF inhibitor BRAFTOVI® capsules (generic name: encorafenib) and a MEK inhibitor MEKTOVI® tablets (generic name: binimetinib)."

"Foundation Medicine, Inc...announced that the company and its collaborators will present a total of 26 abstracts at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting held virtually and in person in Chicago from June 3-7, 2022...Highlights of this data include...Research demonstrating the value of FoundationOne®Liquid CDx blood-based comprehensive genomic profiling (CGP) to support physicians in finding the answers they need to make informed treatment decisions for their patients, such as detecting resistance alterations, and to provide researchers with genomic insights to aid in the discovery and utilization of new biomarkers."

"Roche...announced that new data from clinical trials of 18 approved and investigational medicines across more than 20 cancer types will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held 3-7 June, 2022. Roche and its partners will present clinical studies across medicines, comprehensive genomic tests, and real-world data at this year’s meeting."

"Aadi Bioscience, Inc...announced partnerships with prominent next generation sequencing (NGS) providers and leaders in genomic testing and profiling, including Foundation Medicine, Tempus and others. We expect these collaborations to expedite patient identification for the ongoing PRECISION 1 trial of nab-sirolimus in patients harboring tumors with inactivating alterations in TSC1 or TSC2 genes....'We expect to report preliminary data from this trial in the first half of next year.'"

"Texas Oncology announced...that it has entered into an agreement with Foundation Medicine...to provide Texas Oncology care teams with access to its Food and Drug Administration (FDA)-approved blood-based comprehensive genomic profiling (CGP) test, FoundationOne®Liquid CDx....'At Foundation Medicine, we recognize the critical need for genomic testing options to support treatment planning in each patient's unique circumstance. When tumor tissue is not available or adequate, our liquid biopsy test can provide oncologists with the insights needed to implement precision treatment strategies across all cancer types,' said Geoff Oxnard...'We are committed to expanding precision medicine to cancer patients in the community and are proud to collaborate with Texas Oncology as it works to set the standard around the pathways needed to enable informed decisions about biomarker-driven care.'"

"Texas Oncology announced...that it has entered into an agreement with Foundation Medicine...to provide Texas Oncology care teams with access to its Food and Drug Administration (FDA)-approved blood-based comprehensive genomic profiling (CGP) test, FoundationOne®Liquid CDx."

"The Precision Cancer Consortium (PCC), a group of biopharmaceutical firms collaborating to increase access to genomic testing in oncology, said on Tuesday that it has launched with Bayer, GlaxoSmithKline, Novartis, and Roche as its inaugural members...The PCC said its focus is on increasing patient access to precision diagnostics based on next-generation sequencing and other genomic technologies in both routine care and clinical trials."

"Roche (SIX: RO, ROG;OTCQX: RHHBY) today announced that it will be showcasing next generation diagnostics solutions that will deliver fast and accurate results to help clinicians improve patient care and help reduce the healthcare burden at the 24th IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicines (EuroMedLab) in Munich, Germany (rescheduled dates 10 - 14 April 2022)...An evaluation of the recently launched AVENIO Tumor Tissue Comprehensive Genomic Profiling (CGP) Kit for oncology research will be presented."

"Foundation Medicine, Inc. today announced that the company and its collaborators will present a total of nine studies, including two clinical science symposia presentations and seven poster discussions, at the 2022 American Association for Cancer Research (AACR) Annual Meeting from April 8-13."

"Roche...announced that it has entered into a collaboration with Bristol Myers Squibb to support the advancement of two assays for use in clinical trials with the development and deployment of two new digital pathology algorithms...In the first project under this collaboration, Roche Digital Pathology is creating an AI-based image analysis algorithm to aid pathologists in interpreting the on-market VENTANA PD-L1 (SP142) Assay. Bristol Myers Squibb will use this algorithm to generate biomarker data from clinical trial samples."

"The US Food and Drug Administration...approved Merck's PD-1 inhibitor Keytruda (pembrolizumab) for advanced, previously treated endometrial cancer patients whose tumors express high microsatellite instability (MSI) or harbor DNA mismatch repair deficiencies (dMMR)...The FDA also approved Roche's Ventana MMR RxDx Panel as an immunohistochemistry-based companion diagnostic to select patients with dMMR tumors for Keytruda treatment."

“Foundation Medicine, Inc....announced it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) EGFR exon 19 deletions or exon 21 (L858R) alterations and are appropriate for treatment with EGFR Tyrosine Kinase Inhibitors (TKI) approved by FDA for this indication.”