Natera Announces Innovation Roadmap, with Advancements in MRD and Early Cancer Detection
Natera (NASDAQ: NTRA) announced updates to its oncology innovation roadmap at the 43rd Annual J.P. Morgan Healthcare Conference. The company introduced three key developments:
1. A new version of Signatera leveraging whole genome sequencing (WGS), now available for research and clinical use, detecting down to low single-digit parts per million.
2. A novel tissue-free molecular residual disease (MRD) capability, with first launch expected in mid-2025 for colorectal cancer (CRC), utilizing methylation-based technologies.
3. Preliminary data for their Early Cancer Detection (ECD) assay, showing 92% detection of stage 1 CRC and 95% detection overall, with 91% specificity. The company plans to present additional data from the PROCEED-CRC cohort later this year, followed by an FDA-grade validation study if results are positive.
Natera (NASDAQ: NTRA) ha annunciato aggiornamenti sulla sua roadmap per l'innovazione oncologica durante il 43° Annual J.P. Morgan Healthcare Conference. L'azienda ha presentato tre sviluppi chiave:
1. Una nuova versione di Signatera che utilizza il sequenziamento dell'intero genoma (WGS), ora disponibile per la ricerca e l'uso clinico, in grado di rilevare fino a bassi livelli di parti per milione.
2. Una nuova capacità di malattia residua molecolare (MRD) senza necessità di tessuto, con il primo lancio previsto per metà 2025 per il cancro colorettale (CRC), utilizzando tecnologie basate sulla metilazione.
3. Dati preliminari per il loro test di Rilevamento Precoce del Cancro (ECD), che mostrano il 92% di rilevamento per il CRC di stadio 1 e il 95% di rilevamento complessivo, con una specificità del 91%. L'azienda prevede di presentare ulteriori dati dal coorte PROCEED-CRC entro la fine dell'anno, seguiti da uno studio di validazione di grado FDA se i risultati saranno positivi.
Natera (NASDAQ: NTRA) anunció actualizaciones en su hoja de ruta para la innovación oncológica en la 43ª Conferencia Anual de Salud de J.P. Morgan. La empresa introdujo tres desarrollos clave:
1. Una nueva versión de Signatera que utiliza la secuenciación del genoma completo (WGS), ahora disponible para investigación y uso clínico, capaz de detectar hasta bajos niveles en partes por millón.
2. Una nueva capacidad de enfermedad residual molecular (MRD) sin necesidad de tejido, con el primer lanzamiento previsto para mediados de 2025 para el cáncer colorrectal (CRC), utilizando tecnologías basadas en la metilación.
3. Datos preliminares para su prueba de Detección Temprana de Cáncer (ECD), mostrando un 92% de detección en el CRC en estadio 1 y un 95% de detección en general, con una especificidad del 91%. La empresa planea presentar datos adicionales del cohorte PROCEED-CRC más adelante este año, seguido de un estudio de validación de grado FDA si los resultados son positivos.
네이타라(NASDAQ: NTRA)는 제43회 JP모건 헬스케어 컨퍼런스에서 자신의 종양학 혁신 로드맵 업데이트를 발표했습니다. 회사는 세 가지 주요 개발 사항을 소개했습니다:
1. 전장 유전체 서열 분석(WGS)을 활용한 새로운 버전의 Signatera로, 현재 연구 및 임상 사용을 위해 제공되며, 백만 분의 1 수준의 낮은 농도까지 검출할 수 있습니다.
2. 조직이 필요 없는 분자 잔여 질병(MRD)의 새로운 기능으로, 최초 출시가 2025년 중반으로 예상되는 대장암(CRC)을 위해 메틸화 기반 기술을 활용할 것입니다.
3. 조기 암 발견(ECD) 검사에 대한 초기 데이터로, 1기 CRC에서 92%의 발견률과 95%의 전체 발견률, 91%의 특이를 보여줍니다. 회사는 올해 말 PROCEED-CRC 코호트의 추가 데이터를 발표할 계획이며, 결과가 긍정적일 경우 FDA 규격의 검증 연구를 진행할 것입니다.
Natera (NASDAQ: NTRA) a annoncé des mises à jour de sa feuille de route pour l'innovation oncologique lors de la 43e Conférence Annuelle sur la Santé de J.P. Morgan. L'entreprise a présenté trois développements clés :
1. Une nouvelle version de Signatera utilisant le séquençage génomique complet (WGS), désormais disponible pour la recherche et l'utilisation clinique, capable de détecter des niveaux aussi bas que quelques parties par million.
2. Une nouvelle capacité de maladie résiduelle moléculaire (MRD) sans besoin de tissu, avec un premier lancement prévu pour la mi-2025 pour le cancer colorectal (CRC), utilisant des technologies basées sur la méthylation.
3. Des données préliminaires pour leur test de Détection Précoce du Cancer (ECD), montrant 92 % de détection du CRC au stade 1 et 95 % de détection globale, avec une spécificité de 91 %. L'entreprise prévoit de présenter des données supplémentaires du cohorte PROCEED-CRC plus tard cette année, suivies d'une étude de validation de niveau FDA si les résultats sont positifs.
Natera (NASDAQ: NTRA) gab auf der 43. jährlichen J.P. Morgan Healthcare Conference Updates zu seiner Innovations-Roadmap in der Onkologie bekannt. Das Unternehmen stellte drei wichtige Entwicklungen vor:
1. Eine neue Version von Signatera, die die gesamte Genom-Sequenzierung (WGS) nutzt und jetzt für Forschungs- und klinische Zwecke verfügbar ist, und die bis zu niedrige einstellige Teile pro Million nachweisen kann.
2. Eine neuartige gewebefreie molekulare Restkrankheit (MRD) -Funktion, deren erste Markteinführung für Mitte 2025 für kolorektalen Krebs (CRC) erwartet wird, unter Verwendung von methylierungsbasierten Technologien.
3. Vorläufige Daten für ihren Früherkennungstest bei Krebs (ECD), der 92 % Nachweisrate für Stadium 1 CRC und 95 % Gesamt-Nachweisrate bei 91 % Spezifität zeigt. Das Unternehmen plant, später in diesem Jahr weitere Daten aus der PROCEED-CRC-Kohorte zu präsentieren, gefolgt von einer FDA-konformen Validierungsstudie, wenn die Ergebnisse positiv sind.
- Launch of new Signatera genome assay with enhanced WGS capabilities
- Development of innovative tissue-free MRD testing launching mid-2025
- Strong preliminary ECD assay performance with 92% stage 1 CRC detection
- Extensive validation with over 100 published ctDNA monitoring studies
- None.
Insights
The announcement of Natera's innovation roadmap represents a significant technological leap in oncology diagnostics. The introduction of Signatera genome assay using whole genome sequencing marks a substantial advancement over the existing exome-based version, potentially offering enhanced sensitivity in detecting molecular residual disease. The capability to detect cancer signatures down to single-digit parts per million demonstrates remarkable precision.
The upcoming tissue-free MRD test for colorectal cancer is particularly noteworthy - it eliminates the need for tumor tissue samples, potentially expanding the addressable market significantly. Early cancer detection data showing
The strategic timing of this announcement at the JP Morgan Healthcare Conference maximizes visibility among institutional investors and industry stakeholders. The three-pronged approach - enhanced Signatera, tissue-free MRD and early cancer detection - creates multiple revenue streams and market opportunities. The colorectal cancer diagnostic market alone is projected to reach
With preliminary financial results already strong for 2024, these product launches represent potential catalysts for revenue growth in 2025-2026. The company's extensive clinical validation database, with over 100 published studies, provides a competitive moat and supports reimbursement discussions with payers.
The technical specifications of these new assays suggest breakthrough potential in cancer diagnostics. The integration of methylation-based technologies for tissue-free testing represents a paradigm shift in MRD monitoring. The preliminary performance metrics for early cancer detection are particularly impressive -
The PROCEED-CRC study results and pending advanced adenoma data will be important for FDA validation. If the advanced adenoma detection rates show similar robustness, this could revolutionize colorectal cancer screening protocols. The combination of presurgical samples and intended use samples from PROCEED-CRC provides a unique development advantage that could accelerate clinical adoption.
Company to provide comprehensive update in a presentation delivered today at the 43rd Annual J.P. Morgan Healthcare Conference
Presentation outlines strength of existing oncology portfolio, along with pipeline of new products and data readouts
“Building on our strong preliminary financial results in 2024, we are poised for an exciting year with multiple potential catalysts,” said Steve Chapman, CEO. “Since launching the oncology business, we have focused on innovating the field of molecular residual disease testing to improve outcomes for patients. Today's announcement extends that commitment with promising new products and technologies in cancer testing.”
Launch of SignateraTM, Designed on Genome
Building on the success of Natera’s exome-based Signatera assay, which has been extensively validated and widely adopted, Natera is pleased to introduce a new version of Signatera leveraging the genome. The test, which is now available for research and clinical use, enables bespoke assay design from a whole genome sequence (WGS) of a patient’s tumor.
The Signatera genome assay benefits from Natera’s patented multiplex polymerase chain reaction (PCR) next generation sequencing (NGS) methodology. The test detects down to low single-digit parts per million (PPM) and leverages Natera’s clinical data leadership from over 100 published studies on circulating tumor DNA (ctDNA) monitoring.
Tissue-free MRD
Natera is pleased to unveil a new tissue-free molecular residual disease (MRD) capability, which is the result of growing expertise in methylation-based technologies and dovetails with its research in early cancer detection. The first launch is expected in mid-2025 in colorectal cancer (CRC), with additional tumor indications to follow. The preliminary data for the CRC assay will be presented at the American Society of Clinical Oncology (ASCO) GI symposium, which takes place Jan. 23-25, 2025.
The Signatera genome assay and the tissue-free MRD assay will be offered alongside the Signatera exome assay, as part of Natera’s portfolio of MRD assays.
Early Cancer Detection (ECD)
The company will also provide the first performance data for its ECD assay, based on the detection of cancer-specific DNA methylation signatures. Natera brings a unique competitive advantage to its ECD program, with access to an extensive amount of early-stage and presurgical tumor samples for use in development, combined with intended use samples from its PROCEED-CRC study. Prospective case-control data to be presented at ASCO GI demonstrated
Presentation and Webcast Details
A presentation outlining the details of this business update will be posted to the Investor Relations (IR) section of Natera’s website at www.investor.natera.com. A webcast will also be broadcast and available on the IR site, beginning at 12:00 pm ET | 9:00 am PT, with a replay available shortly thereafter.
About Natera
Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties that could affect our financial results are discussed in greater detail in the sections titled "Risk Factors" and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our most recent filings on Forms 10-K and 10-Q and in other filings that we make with the SEC from time to time. These documents are available at www.investor.natera.com and on the SEC’s website at www.sec.gov.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250115920690/en/
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090, investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com
Source: Natera, Inc.
FAQ
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