Myriad Genetics Announces Third Patent Granted for Molecular Residual Disease (MRD) with Early Priority Date
Myriad Genetics (NASDAQ: MYGN) has been granted a third patent by the U.S. Patent and Trademark Office, strengthening its position in delivering a tumor-informed, high-definition, molecular residual disease (MRD) assay. The new patent, U.S. patent no. 12,104,212, covers proprietary methods for ultra-sensitive detection of tumor-specific mutations in circulating tumor DNA (ctDNA).
This patent complements two earlier patents related to MRD technology and cell-free DNA preparation methods. Myriad's Precise® MRD assay can track up to thousands of tumor-specific variants, potentially detecting ctDNA at lower levels than other products currently available. The company is leveraging its existing technology, including the FDA-approved MyChoice® CDx companion diagnostic and FirstGeneTM platforms, to develop and commercialize Precise MRD.
Myriad is currently conducting several high-impact studies for its Precise MRD assay, including collaborations with Memorial Sloan Kettering, The University of Texas MD Anderson Cancer Center, and the National Cancer Center Hospital East in Japan. The test is available for use in research studies pursued jointly by Myriad and academic or pharmaceutical investigators.
Myriad Genetics (NASDAQ: MYGN) ha ricevuto un terzo brevetto dall'Ufficio Brevetti e Marchi degli Stati Uniti, rafforzando la sua posizione nel fornire un analisi della malattia residua molecolare (MRD) informata sul tumore e ad alta definizione. Il nuovo brevetto, brevetto statunitense n. 12,104,212, copre metodi esclusivi per la rilevazione ultra-sensibile delle mutazioni specifiche del tumore nel DNA tumorale circolante (ctDNA).
Questo brevetto completa due brevetti precedenti relativi alla tecnologia MRD e ai metodi di preparazione del DNA libero. L'analisi MRD Precise® di Myriad può monitorare fino a migliaia di varianti specifiche del tumore, potenzialmente rilevando ctDNA a livelli più bassi rispetto ad altri prodotti attualmente disponibili. L'azienda sta sfruttando la sua tecnologia esistente, inclusi i dispositivi diagnostici MyChoice® CDx approvati dalla FDA e le piattaforme FirstGeneTM, per sviluppare e commercializzare Precise MRD.
Attualmente, Myriad sta conducendo diversi studi ad alto impatto per il suo analisi MRD Precise, comprese collaborazioni con Memorial Sloan Kettering, The University of Texas MD Anderson Cancer Center, e il National Cancer Center Hospital East in Giappone. Il test è disponibile per l'uso in studi di ricerca condotti congiuntamente da Myriad e ricercatori accademici o farmaceutici.
Myriad Genetics (NASDAQ: MYGN) ha recibido una tercera patente por parte de la Oficina de Patentes y Marcas de EE. UU., fortaleciendo su posición en la entrega de un ensayo de enfermedad residual molecular (MRD) informado por tumor y de alta definición. La nueva patente, la patente estadounidense n. 12,104,212, cubre métodos patentados para la detección ultra-sensible de mutaciones específicas del tumor en ADN tumoral circulante (ctDNA).
Esta patente complementa dos patentes anteriores relacionadas con la tecnología MRD y métodos de preparación de ADN libre. El ensayo MRD Precise® de Myriad puede rastrear hasta miles de variantes específicas del tumor, detectando potencialmente ctDNA a niveles más bajos que otros productos actualmente disponibles. La empresa está aprovechando su tecnología existente, que incluye el diagnóstico complementario MyChoice® CDx aprobado por la FDA y las plataformas FirstGeneTM, para desarrollar y comercializar Precise MRD.
Myriad está llevando a cabo varios estudios de alto impacto para su ensayo MRD Precise, incluyendo colaboraciones con Memorial Sloan Kettering, The University of Texas MD Anderson Cancer Center, y el National Cancer Center Hospital East en Japón. La prueba está disponible para su uso en estudios de investigación llevados a cabo conjuntamente por Myriad e investigadores académicos o farmacéuticos.
Myriad Genetics (NASDAQ: MYGN)는 미국 특허청에서 세 번째 특허를 받았으며, 이는 종양 정보 기반의 고해상도 분자 잔여 질병(MRD) 분석을 제공하는 데 있어 회사의 입지를 강화합니다. 새로운 특허인 미국 특허 번호 12,104,212는 순환 종양 DNA(ctDNA)에서의 종양 특이적 변이를 초민감도로 검출하는 독점 방법을 다룹니다.
이 특허는 MRD 기술 및 세포 자유 DNA 준비 방법과 관련된 두 개의 이전 특허를 보완합니다. Myriad의 Precise® MRD 분석은 수천 개의 종양 특이적 변이를 추적할 수 있으며, 현재 사용 가능한 다른 제품보다 낮은 수준의 ctDNA를 탐지할 수 있습니다. 이 회사는 FDA 승인된 MyChoice® CDx 동반 진단 및 FirstGeneTM 플랫폼을 포함하여 기존 기술을 활용하여 Precise MRD를 개발 및 상용화하고 있습니다.
현재 Myriad는 Memorial Sloan Kettering, The University of Texas MD Anderson Cancer Center, 그리고 일본의 National Cancer Center Hospital East와의 협력을 포함하여 Precise MRD 분석을 위한 여러 고임팩트 연구를 진행하고 있습니다. 이 테스트는 Myriad와 학계 또는 제약 연구자들이 공동으로 진행하는 연구 프로젝트에서 사용 가능합니다.
Myriad Genetics (NASDAQ: MYGN) a reçu un troisième brevet de l'Office américain des brevets et des marques, renforçant sa position dans la fourniture d'un essai de maladie résiduelle moléculaire (MRD) informé par les tumeurs et haute définition. Le nouveau brevet, n° 12,104,212, couvre des méthodes exclusives pour la detection ultra-sensible des mutations spécifiques aux tumeurs dans l'ADN tumoral circulant (ctDNA).
Ce brevet complète deux brevets antérieurs liés à la technologie MRD et aux méthodes de préparation de l'ADN libre. L'essai MRD Précis® de Myriad peut suivre jusqu'à des milliers de variantes spécifiques aux tumeurs, détectant potentiellement ctDNA à des niveaux inférieurs à ceux d'autres produits actuellement disponibles. L'entreprise exploite sa technologie existante, incluant le diagnostic compagnon MyChoice® CDx approuvé par la FDA et les plateformes FirstGeneTM, pour développer et commercialiser Precise MRD.
Myriad réalise actuellement plusieurs études à fort impact pour son essai MRD Précis, y compris des collaborations avec Memorial Sloan Kettering, l'Université du Texas MD Anderson Cancer Center, et le National Cancer Center Hospital East au Japon. Le test est disponible pour une utilisation dans des études de recherche menées conjointement par Myriad et des chercheurs académiques ou pharmaceutiques.
Myriad Genetics (NASDAQ: MYGN) hat vom US-Patent- und Markenamt ein drittes Patent erhalten, das seine Position bei der Bereitstellung eines tumorinformierten, hochauflösenden molekularen Restkrankheits-Assays (MRD) stärkt. Das neue Patent, US-Patent Nr. 12,104,212, umfasst proprietäre Methoden zur ultrasensitiven Erkennung von tumor-spezifischen Mutationen in zirkulierender TumordNA (ctDNA).
Dieses Patent ergänzt zwei frühere Patente im Zusammenhang mit MRD-Technologie und Methoden zur Vorbereitung von zellfreier DNA. Der Precise® MRD-Assay von Myriad kann bis zu tausende tumor-spezifische Varianten verfolgen und ctDNA möglicherweise in geringeren Konzentrationen als andere derzeit verfügbare Produkte nachweisen. Das Unternehmen nutzt seine bestehende Technologie, einschließlich des von der FDA genehmigten MyChoice® CDx Begleitdiagnosetests und der FirstGeneTM-Plattformen, um Precise MRD zu entwickeln und zu vermarkten.
Myriad führt derzeit mehrere hochwirksame Studien zu seinem Precise MRD-Assay durch, einschließlich Kooperationen mit Memorial Sloan Kettering, dem University of Texas MD Anderson Cancer Center und dem National Cancer Center Hospital East in Japan. Der Test ist für die Verwendung in Forschungsstudien verfügbar, die gemeinsam von Myriad und akademischen oder pharmazeutischen Forschern durchgeführt werden.
- Granted third patent for molecular residual disease (MRD) technology
- Precise® MRD assay can detect ctDNA at potentially lower levels than competitors
- Leveraging existing FDA-approved technology for MRD assay development
- Multiple ongoing high-impact studies and collaborations with prestigious institutions
- None.
Insights
The grant of this third patent for Molecular Residual Disease (MRD) technology significantly bolsters Myriad Genetics' intellectual property portfolio in the growing field of cancer diagnostics. This patent, focusing on ultra-sensitive detection of tumor-specific mutations in circulating tumor DNA (ctDNA), complements two earlier patents and strengthens Myriad's position in the competitive MRD market.
The Precise® MRD assay, capable of tracking up to thousands of tumor-specific variants, potentially offers superior sensitivity compared to existing products. This could translate to earlier detection of cancer recurrence and more precise monitoring of treatment efficacy, which are important for improving patient outcomes in oncology.
Myriad's strategic approach of leveraging existing FDA-approved platforms like MyChoice® CDx and FirstGene™ for Precise MRD development may accelerate its path to market. The ongoing high-impact studies and collaborations with prestigious institutions like Memorial Sloan Kettering and MD Anderson Cancer Center add credibility and could provide valuable data for future regulatory submissions and market adoption.
While the MRD market is promising, it's important to note that Myriad faces stiff competition from established players. The company's ability to successfully commercialize Precise MRD and capture market share will depend on clinical performance, cost-effectiveness and reimbursement strategies.
The expansion of Myriad Genetics' patent portfolio in the MRD space is a positive development for the company's long-term growth prospects. The MRD market is projected to grow significantly, with some estimates suggesting a CAGR of over
Financially, the successful commercialization of Precise MRD could diversify Myriad's revenue streams and potentially improve its profit margins. The company's statement about profitable commercialization suggests confidence in the test's economic viability. However, investors should consider the substantial R&D and marketing investments required to bring Precise MRD to market and achieve widespread adoption.
Myriad's market cap of
While this patent news is positive, it's important to note that Myriad's stock performance will also depend on the performance of its existing product lines and overall market conditions in the diagnostics sector.
SALT LAKE CITY, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today 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).
Earlier this year, Myriad Genetics announced the grant of two complementary patents related to foundational platform MRD technology and cell-free DNA preparation methods that each enable highly sensitive and specific tumor-informed, sequencing-based MRD assays such as Precise® MRD.
“The issuance of this third MRD patent supports Myriad’s efforts to establish a proprietary and differentiated MRD assay that tracks up to thousands of tumor-specific variants, making it capable of detecting ctDNA at lower levels than other products in the market today,” said Paul J. Diaz, President and CEO, Myriad Genetics. “We have developed our Precise MRD assay by leveraging Myriad’s existing technology and building upon our FDA-approved MyChoice® CDx companion diagnostic and FirstGeneTM platforms. We believe that our unique set of capabilities will enable us to profitably commercialize Precise MRD, advancing oncology care for patients in this emerging and under-penetrated market.”
Myriad continues to develop its Precise MRD assay to meet the needs of cancer patients, academic partners, and biopharma companies. The test is currently undergoing several high-impact studies while also transitioning to the company’s state-of-the-art laboratory facility in Salt Lake City. Myriad has announced several MRD collaborations, including a metastatic breast cancer study with researchers at Memorial Sloan Kettering, a metastatic renal cell carcinoma study with clinicians at The University of Texas MD Anderson Cancer Center, and a prospective pan-cancer study led by researchers at the National Cancer Center Hospital East in Japan.
Precise MRD is available for use in research studies pursued jointly by Myriad and academic or pharmaceutical investigators.
About Myriad Genetics
Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com.
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including that issuance of a patent will strengthen Myriad’s ability to deliver a tumor-informed, high-definition, MRD assay to market and support Myriad’s efforts to establish a proprietary and differentiated MRD assay, and that Myriad’s unique set of capabilities will enable it to profitably commercialize Precise MRD, advancing oncology care for patients in this emerging and under-penetrated market. These “forward-looking statements” are management’s expectations of future events as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. Such factors include those risks described in the company’s filings with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K filed on February 28, 2024, as well as any updates to those risk factors filed from time to time in the company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. Myriad is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law.
Investor Contact
Matt Scalo
(801) 584-3532
IR@myriad.com
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PR@myriad.com
FAQ
What is the new patent granted to Myriad Genetics (MYGN) for MRD technology?
How many tumor-specific variants can Myriad's Precise MRD assay track?
What existing technologies is Myriad Genetics (MYGN) leveraging for its MRD assay?
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