CAMBRIDGE, Mass. & AUSTIN, Texas--(BUSINESS WIRE)--Foundation Medicine, Inc., a pioneer successful molecular profiling for cancer, and Natera, Inc., a planetary person successful cell-free DNA testing, contiguous launched an aboriginal entree programme for objective usage of FoundationOne®Tracker, a personalized circulating tumor DNA (ctDNA) monitoring assay. In addition, the investigational usage lone mentation of the trial is present disposable for usage successful objective trials.
FoundationOne Tracker combines genomic accusation derived from FoundationOne®CDx, Foundation Medicine’s tissue-based broad genomic profiling test, with personalized assay plan and ctDNA investigation from Natera. The trial offers physicians the quality to serially show their patients’ effect to treatment, particularly immunotherapies, utilizing a elemental humor draw, and to usage those insights to marque informed decisions for aboriginal care. FoundationOne Tracker is present disposable done an aboriginal entree programme to a constricted fig of objective customers, with plans to grow for wide availability successful the United States aboriginal successful 2023.
The existent imaging-based modular of attraction for crab monitoring is not precise oregon applicable to each crab types and treatments, which has an interaction connected diligent outcomes.1-4 For example, immunotherapy is utilized broadly crossed patients with precocious cancer, yet determination remains an unmet request erstwhile assessing effect to therapy and illness progression. FoundationOne Tracker offers physicians a tissue-informed, businesslike and precise instrumentality for attraction effect monitoring (TRM) to pass personalized attraction strategies. It tin beryllium utilized arsenic a complementary instrumentality to imaging successful bid to much accurately measure effect to attraction and pass adjacent steps successful diligent care, peculiarly successful cases erstwhile imaging is ambiguous oregon conflicting.
“We developed FoundationOne Tracker to assistance physicians place patients who are resistant to their existent attraction and whitethorn request further therapy, oregon those who are responding good to therapy and whitethorn payment from skipping unnecessary doses,” says Foundation Medicine Chief Executive Officer Brian Alexander, M.D., M.P.H. “With this caller instrumentality that leverages the molecular fingerprint of the cancer, we anticipation to maximize the interaction of genomic profiling to enactment a higher grade of personalized crab attraction for patients.”
The mentation of FoundationOne Tracker for probe usage was launched successful June 2021 for retrospective investigation of archived specimens, providing a cost-effective and businesslike way to bring personalized monitoring tools to Foundation Medicine’s biopharma and world partners. The investigational usage mentation of the test, which whitethorn beryllium utilized for real-time processing of caller specimens successful ongoing prospective studies, is present disposable to summation earlier insights connected attraction effect successful objective studies.
“We are pleased to collaborate with Foundation Medicine and enactment broader entree to cutting-edge tools that alteration precision medicine,” says Natera’s Chief Executive Officer, Steve Chapman. “This aligns with Natera’s ngo to marque our personalized monitoring assay exertion disposable to each patients and amended outcomes.”
This motorboat intimately follows 2 publications demonstrating the objective validity of FoundationOne Tracker’s worth successful the TRM and molecular residual illness (MRD) settings, respectively. Research published successful Molecular Oncology features results from the OMICO-MoST study, the archetypal precocious pan-cancer coagulated tumor survey to show FoundationOne Tracker’s ctDNA dynamics for attraction effect monitoring for 2 forms of immunotherapy. In different survey recently published successful the International Journal of Molecular Sciences, researchers established the feasibility of ctDNA-based MRD detection successful metastatic colorectal crab patients undergoing surgical resection. These studies are portion of the extended assemblage of grounds some Foundation Medicine and Natera are generating to enactment the worth of integrating tissue-informed ctDNA monitoring successful objective practice.
In February 2022, FoundationOne Tracker was granted a Breakthrough Device designation from the FDA for the assay’s usage successful the detection of MRD successful early-stage crab aft curative therapy. The commercialized motorboat of FoundationOne Tracker expands Foundation Medicine’s portfolio of molecular tests, which includes FDA-approved blood- and tissue-based CGP investigating options and offers physicians a toolkit of options for detecting genomic alterations and tracking attraction effect to assistance usher personalized crab care.
FoundationOne Tracker is commercialized by Foundation Medicine.
Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.
About Foundation Medicine: Your Essential Partner successful Cancer Care
Foundation Medicine is simply a pioneer successful molecular profiling for cancer, moving to signifier the aboriginal of objective attraction and research. We collaborate with a wide scope of partners crossed the crab assemblage and strive to acceptable the modular for quality, technological excellence, and regulatory leadership. Our heavy knowing of crab biology helps physicians marque informed attraction decisions for their patients and empowers researchers to make caller medicines. Every day, we are driven to assistance our partners find answers and instrumentality action, enabling much radical astir the satellite to payment from precision crab care. For much information, delight sojourn america connected www.FoundationMedicine.com and travel america connected Twitter and LinkedIn.
About Natera
Natera™ is simply a planetary person successful cell-free DNA testing, dedicated to oncology, women’s health, and organ health. Our purpose is to marque personalized familial investigating and diagnostics portion of the modular of attraction to support wellness and alteration earlier and much targeted interventions that assistance pb to longer, healthier lives. Natera’s tests are validated by much than 100 peer-reviewed publications that show precocious accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified nether the Clinical Laboratory Improvement Amendments (CLIA) successful Austin, Texas and San Carlos, California. For much information, sojourn www.natera.com.
Forward-Looking Statements (Natera)
All statements different than statements of humanities facts contained successful this property merchandise are forward-looking statements and are not a practice that Natera’s plans, estimates, oregon expectations volition beryllium achieved. These forward-looking statements see quotes of absorption and correspond Natera's expectations arsenic of the day of this property release. Natera disclaims immoderate work to update these forward-looking statements. These forward-looking statements are taxable to known and chartless risks and uncertainties that whitethorn origin existent results to disagree materially, including with respect to whether the results of objective oregon different studies volition enactment the usage of our merchandise offerings, the interaction of results of specified studies, oregon our expectations of the benefits of our tests and merchandise offerings to patients, providers and payors. Additional risks and uncertainties are discussed successful greater item successful "Risk Factors" successful Natera’s caller filings connected Forms 10-K and 10-Q and successful different filings Natera makes with the SEC from clip to time. These documents are disposable astatine www.natera.com/investors and www.sec.gov.
1. Nishino M. Tumor effect appraisal for precision crab therapy: effect valuation criteria successful coagulated tumors and beyond. Am Soc Clin Oncol Educ Book. 2018;38:1019-1029. doi:10.1200/EDBK_201441
2. Schwartz LH, Seymour L, Litière S, et al. RECIST 1.1 - Standardisation and disease-specific adaptations: Perspectives from the RECIST Working Group. Eur J Cancer. 2016;62:138-145. doi:10.1016/j.ejca.2016.03.082
3. Stewart DJ, Macdonald DB, Awan AA, Thavorn K. Optimal frequence of scans for patients connected crab therapies: A colonisation kinetics assessment. Cancer Med. 2019;8(16):6871-6886. doi:10.1002/cam4.2571
4. Jia W, Gao Q, Han A, Zhu H, Yu J. The imaginable mechanism, designation and objective value of tumor pseudoprogression aft immunotherapy. Cancer Biol Med. 2019;16(4):655-670. doi:10.20892/j.issn.2095-3941.2019.0144
Source: Foundation Medicine
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