Articles from Foundation Medicine

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Day One Biopharmaceuticals’ OJEMDA, a type II RAF inhibitor, for the treatment of patients six months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. FoundationOne CDx is the first and only companion diagnostic for OJEMDA.

Foundation Medicine, Inc. today announced it has awarded two grants to organizations working to address disparities in biomarker testing for breast and prostate cancer following its open call for grants in April 2024. Foundation Medicine requested proposals that included collaboration between two separate organizations, recognizing that addressing disparities in oncology care requires multi-stakeholder partnerships.

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for TEPMETKO® (tepotinib) developed by EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada. TEPMETKO received accelerated approval from the FDA in February 2021 and traditional approval in February 2024 for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations (METex14).1 FoundationOne Liquid CDx is the first FDA-approved companion diagnostic to identify patients who may be eligible for TEPMETKO.

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for Itovebi™ (inavolisib) in combination with palbociclib (Ibrance®) and fulvestrant, a therapy developed by Genentech, a member of the Roche group, which has been contemporaneously approved for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.

Foundation Medicine, Inc. today announced it was awarded its second consecutive, five-year contract by the U.S. Department of Veterans Affairs (VA) to provide tumor molecular profiling tests and services to eligible Veterans living with cancer as part of the VA’s National Precision Oncology Program. The national contract covers Foundation Medicine’s tissue-based test FoundationOne®CDx, liquid-based test FoundationOne®Liquid CDx, tissue-based RNA sequencing test FoundationOne®RNA and FoundationOne®Heme for hematologic malignancies.

Foundation Medicine, Inc. today announced a collaboration with Syndax Pharmaceuticals (Nasdaq: SNDX) to develop a companion diagnostic for the identification of acute myeloid leukemia (AML) patients harboring an NPM1 mutation. As part of the collaboration, Syndax will also support Foundation Medicine’s efforts to pursue regulatory approval of an assay based on the FoundationOne®Heme platform.

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx and FoundationOne®Liquid CDx to be used as companion diagnostics for AstraZeneca’s and Merck’s (known as MSD outside of the United States and Canada) Lynparza® (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). This decision from the FDA follows the approval of FoundationOne CDx for Lynparza to identify mCRPC patients with homologous recombination repair (HRR) gene alterations and the approval of FoundationOne Liquid CDx for Lynparza to identify patients with BRCA1, BRCA2 and/or ATM alterations in mCRPC.

Foundation Medicine, Inc. today announced a collaboration to develop Foundation Medicine’s RNA platform as a companion diagnostic for Merus N.V.’s (Nasdaq: MRUS) bispecific antibody zenocutuzumab (Zeno) to treat patients with neuregulin 1 fusion (NRG1+) cancer.

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for AKEEGA® (niraparib and abiraterone acetate) from Janssen Biotech, Inc, a Johnson & Johnson company, the first and only FDA-approved dual-action tablet combining PARP inhibition and hormone therapy for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).1 This decision from the FDA follows the approval of FoundationOne®CDx, Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) test, for the same therapy and indication in August 2023.

Foundation Medicine, Inc., today announced that it has formed a collaboration with Repare Therapeutics, a leading clinical-stage precision oncology company, to provide prospective genomic profiling to patients in Repare’s ongoing Phase I/Ib MYTHIC study (NCT04855656) of lunresertib alone or in combinations in genomically-defined patient populations. The companies are also exploring opportunities to develop FoundationOne®CDx, a tissue-based comprehensive genomic profiling test, as a companion diagnostic for the lunresertib program.

Foundation Medicine, Inc. and PMV Pharmaceuticals, Inc. (NASDAQ: PMVP; “PMV Pharma”) today announced a partnership to develop Foundation Medicine’s tissue-based comprehensive genomic profiling test, FoundationOne®CDx, as a companion diagnostic for PMV Pharma’s rezatapopt, a first-in-class, investigational therapy for patients with locally advanced or metastatic solid tumors that have a TP53 Y220C mutation.

Foundation Medicine, Inc., today announced that 22 new pieces of research from its robust oncology diagnostics portfolio will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting from May 31 to June 4 in Chicago.

Foundation Medicine, Inc., today announced the U.S. launch of FoundationOne®RNA, a tissue-based RNA sequencing test for the detection of cancer-related fusions across 318 genes. FoundationOne RNA enables reporting of fusions in all solid tumors and may be valuable for detecting fusions in certain cancers, such as non-small cell lung cancer (NSCLC), pancreatic cancer, cholangiocarcinoma, sarcoma, thyroid cancer and bladder cancer. This test was made available to researchers in September 2023 for research and for investigational use, and today is being launched for clinical use.

Foundation Medicine, Inc., a genomics company dedicated to transforming cancer care, today announced that research from its robust oncology diagnostics portfolio will be presented at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, California April 5-10, 2024.

Foundation Medicine, Inc., today announced the appointment of Roche executive, Dan Malarek, as Chief Executive Officer (CEO). Malarek succeeds Brian Alexander, M.D., who will take on a senior leadership role in Roche’s Pharma Research and Development based in Boston.

Foundation Medicine Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for AstraZeneca’s Truqap™ (capivasertib) in combination with Faslodex® (fulvestrant) which has been contemporaneously approved for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

Foundation Medicine, Inc., and Pierre Fabre Laboratories today announced a collaboration to develop Foundation Medicine’s high-quality genomic tests, FoundationOne®CDx and FoundationOne®Liquid CDx, as companion diagnostics for new targeted therapies to treat patients with non-small cell lung cancer (NSCLC). The companies will work collaboratively to seek the regulatory approval for Foundation Medicine assays which detect mutations including BRAFV600E to identify patients for potential treatment with Pierre Fabre Laboratories’s BRAF/MEK inhibitor combination regimen, BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib), in the European Union. This combination therapy is currently under evaluation by the European Medicines Agency for patients with BRAFV600-mutant advanced NSCLC and was evaluated in a clinical trial sponsored by Pfizer and supported by Pierre Fabre.

Foundation Medicine, Inc., today announced its participation in the National Cancer Institute’s (NCI) Combination Therapy Platform Trial with Molecular Analysis for Therapy Choice (ComboMATCH) initiative to test new therapy combinations in select groups of adults and children with cancer. NCI is part of the National Institutes of Health. Foundation Medicine is one of nearly 40 participating Designated Laboratories, meaning that oncologists at participating ComboMATCH clinical sites may utilize their patients' FoundationOne®CDx commercial testing results to help determine their eligibility for ComboMATCH treatment trials.

Foundation Medicine, Inc., today announced that it has expanded its partnership with Sequanta Technologies Co., Ltd. (“Sequanta”) to provide genomic profiling services to support clinical research and the development of oncology therapies in China. Foundation Medicine has a long-standing partnership with Sequanta as its in-house laboratory in China since 2014 with FoundationOne® and FoundationOne®CDx launches in 2015 and 2018, respectively. With this expanded partnership, Foundation Medicine will conduct a tech transfer of its genomic profiling tests technologies for research and investigational uses starting with FoundationOne®Liquid CDx, a blood-based comprehensive genomic profiling test in November 2023, and a transfer of FoundationOne CDx, a tissue-based comprehensive genomic profiling test, in March 2024.

Foundation Medicine Inc. and Roche today announced that they will present the results from a randomized, global precision oncology study designed to prospectively assess the efficacy and safety of molecularly-guided therapy for patients with unfavorable subset cancer of unknown primary (CUP). The results will be presented as a late breaking abstract on Saturday, October 21 at the European Society for Medical Oncology (ESMO) Annual Meeting in Madrid, Spain.

Foundation Medicine, Inc., today announced that the company will present 11 abstracts demonstrating the value of high-quality biomarker tests to inform cancer care at the 2023 European Society for Medical Oncology (ESMO) Annual Meeting from October 20-24 in Madrid, Spain.

Foundation Medicine Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx and FoundationOne®Liquid CDx to be used as companion diagnostics for Pfizer’s BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation.

Foundation Medicine, Inc., and Natera, Inc., today announced the broad clinical launch of FoundationOne®Tracker, a personalized tissue-informed circulating tumor DNA (ctDNA) test to monitor cancer patients’ response to therapy. FoundationOne Tracker is now available to all U.S. healthcare providers for treatment response monitoring (TRM).

Foundation Medicine Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Eli Lilly and Company’s Retevmo (selpercatinib), which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

Foundation Medicine Inc., today announced the launch of the research use and investigational use versions of FoundationOne®RNA, its broad tissue-based RNA test. While DNA sequencing with optimized targeting can detect most fusions, FoundationOne RNA can provide another layer of sophisticated fusion detection in 318 genes through RNA sequencing.

Foundation Medicine Inc., today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Janssen Biotech, Inc. (Janssen’s) AKEEGA™ (niraparib and abiraterone acetate Dual Action Tablet), which was approved by the FDA for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced a grant to Moffitt Cancer Center (Moffitt) and LUNGevity Foundation to help fund their COMPASS initiative. COMPASS, which stands for Community Outreach to Empower Black Patients with Non-Small Cell Lung Cancer (NSCLC) to Improve Engagement and Awareness, is a patient education program that will operate within a clinical trial designed to assess circulating tumor DNA (ctDNA) dynamics in Black patients with NSCLC.

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, announced today organizational changes to the executive leadership team to position the company for continued growth and usher in the next era of cancer care.

Foundation Medicine Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for BRAFTOVI® (encorafenib) in combination with cetuximab which is currently FDA-approved for adult patients with previously treated metastatic colorectal cancer (mCRC) harboring a BRAF V600E alteration. This now makes FoundationOne Liquid CDx the only comprehensive genomic profiling (CGP) test FDA-approved to identify patients with BRAF V600E alterations in mCRC who may be appropriate for treatment with BRAFTOVI in combination with cetuximab.

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced that it has entered a strategic collaboration with Merck KGaA, Darmstadt, Germany to develop FoundationOne®Liquid CDx and FoundationOne®CDx as companion diagnostics in the U.S. market for selected marketed and pipeline treatments. This new agreement builds on the data solutions partnership Merck KGaA, Darmstadt, Germany and Foundation Medicine entered in 2020 to help accelerate the development of novel targeted therapies, individually and in combination.

Foundation Medicine, Inc., today announced the launch of its tissue-naïve circulating tumor DNA (ctDNA) monitoring assay, FoundationOne®Monitor, for research use in retrospective studies. Currently available for biopharma customers, FoundationOne Monitor provides unique access to Foundation Medicine’s ctDNA tumor fraction biomarker that incorporates information to improve sensitivity and maintain high specificity to monitor ctDNA levels.

Foundation Medicine, Inc., a leader in molecular profiling for cancer, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for EXKIVITY® (mobocertinib), which is currently FDA-approved for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. For full Indication, Important Safety Information and link to the Prescribing Information, please see ‘About Exkivity’ below. FoundationOne Liquid CDx is the only blood-based comprehensive genomic profiling (CGP) test that is FDA-approved to detect EGFR exon 20 insertion mutations to identify patients who may be appropriate for treatment with EXKIVITY.

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer announced today, an expanded collaboration with Bristol Myers Squibb (NYSEBMY) to develop Foundation Medicine’s tissue-based test, FoundationOne®CDx as a companion diagnostic for Bristol Myers Squibb’s investigational tyrosine kinase inhibitor, repotrectinib.

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced that the company and its collaborators will present a total of 10 studies at the 2023 American Association for Cancer Research (AACR) Annual Meeting from April 14-19 in Orlando, Florida.

Point32Health, the parent company of Harvard Pilgrim Health Care and Tufts Health Plan, and Foundation Medicine, a pioneer in molecular profiling for cancer, have 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.

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, 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. FoundationOne CDx, a tissue-based comprehensive genomic profiling (CGP) test, and FoundationOne Liquid CDx, a CGP liquid biopsy test, are used to identify patients who may benefit from treatment with specific FDA-approved targeted therapies.

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today 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., a pioneer in molecular profiling for cancer, 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., a pioneer in molecular profiling for cancer, and Natera, Inc., a global leader in cell-free DNA testing, today 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.

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today 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. FoundationOne Liquid CDx is the first and only blood-based companion diagnostic approved for Rozlytrek (entrectinib). This decision from the FDA follows the approval of Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) test, FoundationOne®CDx, for the same therapy last year.

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today 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. Group approvals are granted when evidence is sufficient to conclude that a companion diagnostic is appropriate for use with a specific group of therapies, rather than specific products.1

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced the launch of FoundationReport+, a new interactive digital report to enhance the useability of comprehensive genomic profiling (CGP) results. The digital view of the Foundation Medicine report provides physicians with an adaptable experience to view genomic insights and supports more efficient and streamlined treatment decisions for their patients.

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, and Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced a collaboration to develop FoundationOne®CDx as a companion diagnostic for Day One’s lead investigational therapy, tovorafenib (DAY101).

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.

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced that the company and its collaborators will present 14 abstracts at the 2022 European Society for Medical Oncology Congress being held virtually and in person in Paris from September 9-13, 2022.

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). In this investigation, researchers compared the ability of FoundationOne®CDx and FoundationOne®Liquid CDx comprehensive genomic profiling (CGP) to limited tissue testing in detecting actionable, guideline-recommended biomarkers for targeted treatment planning in patients with advanced non-squamous non-small cell lung cancer (aNSCLC).

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for the two indications of Rozlytrek® (entrectinib), a targeted therapy developed by Genentech, a member of the Roche Group. As a companion diagnostic, FoundationOne CDx can be used to identify patients with ROS1-positive non-small cell lung cancer (NSCLC), or patients with Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion-positive solid tumors who may be appropriate for treatment with Rozlytrek (entrectinib).

Today Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, 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., a pioneer in molecular profiling for cancer, today 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.

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today 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.

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.

Foundation Medicine, Inc. a pioneer in molecular profiling for cancer, today 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.

Foundation Medicine, Inc. today announced that it 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 Microsatellite Instability High (MSI-H) status solid tumors who may be appropriate for treatment with Merck’s KEYTRUDA® (pembrolizumab). FoundationOne CDx is the first and only FDA-approved companion diagnostic to aid in identifying patients with MSI-H solid tumors for whom treatment with KEYTRUDA may be appropriate.

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device designation for its circulating tumor DNA (ctDNA) detection and molecular monitoring assay, FoundationOne®Tracker. The assay uses optimized algorithms for identifying patient-specific variants and a personalized assay design that allows for the detection of ctDNA in plasma. The Breakthrough Device designation was granted for the assay’s use in the detection of molecular residual disease, commonly known as MRD, in early-stage cancer after curative therapy. This molecular detection can help guide further therapy decisions depending on MRD status and an individual’s risk of relapse.

Foundation Medicine, Inc. today announced a collaboration with Eli Lilly and Company (Lilly) for the development of Foundation Medicine’s tissue- and blood-based assays as companion diagnostics for RETEVMO® and other therapies in Loxo Oncology at Lilly’s pipeline. The partnership will initially explore the use of FoundationOne®CDx for adult patients with metastatic rearranged transfection (RET) fusion across tumor types who may be eligible for Lilly’s RET inhibitor, RETEVMO in the United States and European Union.

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for two groups of current and future FDA-approved therapeutics in melanoma, which includes BRAF inhibitor monotherapies targeting BRAFV600E and BRAF/MEK inhibitor combination therapies targeting BRAFV600E or V600K mutations. This approval makes FoundationOne®CDx the only comprehensive genomic profiling (CGP) test approved as a companion diagnostic across two groups of targeted therapies, representing an important step toward simplifying decision making for oncologists.

Foundation Medicine, Inc. today announced that the company has signed agreements for in-network provider status with Humana Military and Health Net Federal Services, which administer the TRICARE health program for military members, retirees and their families (TRICARE).1,2 TRICARE is one of the largest health plans in the United States with 9.6 million beneficiaries. Under the new agreements, TRICARE beneficiaries now have improved access to Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) tests, FoundationOne®CDx and FoundationOne®Liquid CDx, in accordance with their approved indications for all solid tumors.

Foundation Medicine, Inc. today announced the appointment of Dymeka Harrison, MBA, as its Chief Commercial Officer. In this role, Harrison will develop and execute global clinical commercial strategy, champion a broader understanding of comprehensive genomic profiling (CGP) and promote Foundation Medicine’s proven portfolio of testing services.

Foundation Medicine, Inc. today announced the appointment of Mia Levy, MD, PhD, as its Chief Medical Officer. Dr. Levy is a practicing medical oncologist specializing in the treatment of breast cancer and a nationally recognized leader in biomedical informatics. She joins Foundation Medicine following an accomplished tenure as Director of the Cancer Center at Rush University Medical Center in Chicago.

Science 37 and Foundation Medicine today announced a collaboration to enable decentralized clinical research in oncology that will optimize recruitment and enrollment, improve patient retention, and expand access to precision cancer care.

Foundation Medicine, Inc. today announced a partnership to integrate its comprehensive genomic profiling (CGP) and other testing services with Epic’s electronic medical record (EMR) system. Once completed, all providers who use Foundation Medicine’s instance of Epic will be able to electronically order Foundation Medicine tests within the Epic network. The integration is designed to support oncology practices, academic medical centers and other health systems by providing easy access to clinical and genomic information in one place to better enable more streamlined clinical decision making. This integration is one of many updates Foundation Medicine is making across its portfolio to help expand precision oncology through efficient and high-quality, data-driven insights.

Foundation Medicine, Inc. today announced the appointment of Sanket Agrawal as its Chief BioPharma Business Officer. Drawing on his deep biotech experience, he will lead and expand the company’s large and growing set of collaborations with biotech and pharmaceutical partners to support the development of innovative cancer treatments. Foundation Medicine currently works with more than 65 BioPharma companies who leverage Foundation Medicine’s genomic insights to support therapeutic discovery, development, and commercialization. This includes helping them to uncover promising avenues of research for new targeted therapies, designing more efficient clinical trials, identifying patients who may be eligible for those trials and companion diagnostic development.

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic to aid in identifying patients with MET exon 14 skipping (METex14) in metastatic non-small cell lung cancer (NSCLC) for whom treatment with TABRECTA® (capmatinib) may be appropriate. TABRECTA® is the first therapy approved by the FDA for adult patients with metastatic NSCLC whose tumors have an alteration that leads to METex14. FoundationOne Liquid CDx analyzes the largest genomic region of any FDA-approved comprehensive liquid biopsy test and was approved by the FDA in August 2020 to report genomic alteration results for patients with any solid tumor.

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for ALUNBRIG® (brigatinib), which is currently FDA-approved for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. FoundationOne CDx, the only FDA-approved tissue-based comprehensive genomic profiling (CGP) test, is now able to detect ALK+ mNSCLC and identify patients who may be appropriate for treatment with ALUNBRIG which is approved as a first-line or later-line therapy.

Oncology practices will now be able to order and track Foundation Medicine, Inc.’s comprehensive genomic profiling (CGP) tests for their patients without leaving Flatiron Health’s OncoEMR® platform, the two companies announced today.

Foundation Medicine, Inc. and its collaborators today announced results from a Dana-Farber Cancer Institute-led study that used genomic testing, including Foundation Medicine’s liquid-based comprehensive genomic profiling (CGP) test, FoundationOne®Liquid CDx, among several assays, to investigate resistance mechanisms in 38 patients with cancer treated with a KRAS G12C inhibitor. The study found a complex landscape of acquired resistance mechanisms, with putative resistance mechanisms identified in 45% of patients. These mechanisms were diverse, and some patients (18%) had multiple resistance alterations. Study findings support the need for development of additional KRAS inhibitors and combination treatment strategies and reinforce the utility of liquid biopsy assays in evaluating resistance. The study, “Acquired Resistance to KRAS G12C Inhibition in Cancer,” was published yesterday in The New England Journal of Medicine.

Foundation Medicine, Inc. and Natera, Inc. (NASDAQNTRA), today announced the launch of the research use version of FoundationOne®Tracker, Foundation Medicine’s personalized circulating tumor DNA (ctDNA) monitoring assay. FoundationOne Tracker uniquely combines Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) platform with Natera’s expertise in ctDNA monitoring.

Foundation Medicine, Inc. and its collaborators announced today the presentation of new data analyzing the genomic landscape, comprehensive genomic profiling (CGP) utilization and treatment patterns among more than 11,000 men with advanced prostate cancer, including 12% with a predicted African genomic ancestry. In what is believed to be the largest known cohort of its kind, researchers found that despite similar rates of actionable gene alterations between men of European and African ancestry, men of African ancestry were less likely to receive CGP early in their treatment course and less likely to be enrolled in clinical trials. These findings highlight the importance of additional factors, beyond inherent differences in disease biology, in potentially driving disparities in outcomes. They also underscore the need to expand access to precision medicine and clinical trial enrollment. Data will be presented during an oral presentation on June 8 at the 2021 American Society of Clinical Oncology Virtual Scientific Program (ASCO21).

Foundation Medicine, Inc. today announced that the company and its collaborators will present a total of 29 studies, including two clinical science symposia presentations and two poster discussions, at the 2021 American Society of Clinical Oncology Virtual Scientific Program (ASCO21) from June 4-8. Among the presentations are data reinforcing the role of comprehensive genomic profiling (CGP) in increasing equitable patient access to precision medicine tools, as well as studies highlighting the clinical utility of CGP and the power of real-world data to inform treatment decisions and better understand disparities in care.