Supporting tailored therapy for more patients to optimize outcomes

 

El National Institute for Health and Care Excellence (NICE) del Reino Unido ha publicado una nueva guía en la que respalda el uso de EndoPredict, una herramienta de diagnóstico de vanguardia que ayuda a los profesionales sanitarios a tomar decisiones sobre el uso de la quimioterapia en pacientes con cáncer de mama precoz ER+ HER2- con ganglios linfáticos positivos.¹

The newly released guidance specifically targets postmenopausal early breast cancer patients with 1-3 positive lymph nodes, aiming to guide adjuvant chemotherapy decisions. This update is a further testimony of the continuous evolution of patient care, with a focus on personalized and targeted approaches to improve patient outcomes.

EndoPredict has been a trusted genomic signature since its initial endorsement by NICE in 2018 for lymph node negative and micrometastatic early breast cancer cases. The extended recommendation confirms EndoPredict as a reliable and accurate molecular diagnostic tool, offering healthcare professionals valuable and fast insights into tailoring treatment plans for their patients.

“We are honored by the NICE’s latest recommendation for EndoPredict®, underscoring our commitment to advancing patient care through innovative diagnostic solutions,” said Apostolos Siscoglou, General Manager EU and LATAM at Myriad Genetics (Note: EndoPredict® is now part of Eurobio Scientific). “This guidance reaffirms the accuracy and cost efficacy of EndoPredict®, in guiding treatment decisions and reflects our dedication to supporting healthcare professionals in their mission to provide the highest quality care to patients.“

 

Summary of NICE recommendations concerning EndoPredict

Lymph node positive early breast cancer

 

Can be used

• Use as options alongside consideration of clinical risk factors to guide adjuvant chemotherapy decisions for ER- or PR-positive, HER2-negative early breast cancer with 1 to 3 positive lymph nodes.
• Applicable to postmenopausal women, men, and trans, non-binary, or intersex individuals based on their hormonal profile.

Should not be used

• Should not be used to guide adjuvant chemotherapy decisions for premenopausal women with ER- or PR-positive, HER2-negative early breast cancer with 1 to 3 positive lymph nodes.

Lymph Node-Negative and Micrometastatic Early Breast Cancer

Can be used with evidence generation

• Can be used in the NHS to guide adjuvant chemotherapy decisions for ER- or PR-positive, HER2-negative, and lymph node (LN)-negative (including micrometastatic disease) early breast cancer, only if:

1. They have an intermediate risk of distant recurrence using a validated tool.
2. Clinicians and companies provide timely, complete, and linkable record-level test data to the National Cancer Registration and Analysis Service.

Conditions for use

Use to guide adjuvant chemotherapy decisions for ER- or PR-positive, HER2-negative early breast cancer only if:

• The person having the test will use the results to help them choose, with their healthcare professional, whether or not to have adjuvant chemotherapy.
• The tests are used within their intended purpose.
• Use the test and results alongside NICE’s guideline on shared decision-making.

The committee emphasized shared decision-making, considered turnaround time, discussed prognostic and predictive abilities, and addressed economic considerations for each test.

You can find the full recommendations here. 

 

What is EndoPredict?

EndoPredict is a prognostic and predictive test combining molecular and clinical factors that provides individualized results, allowing you to make confident decisions about adjuvant chemotherapy and the possibility to stop endocrine therapy after 5 years in ER+/HER2-early-stage breast cancer.

EndoPredict gives clear results and actionable insights for treatment decisions:

• Distant recurrence risk within years 0–10²
• Absolute individualized chemotherapy benefit at 10 years³
• Late distant recurrence risk up to 15 years⁴

Gain timely access to genomic insights fostering a pathway to better patient outcomes.

EndoPredict is provided by Eurobio Scientific, committed to improving timely access to genomic insights, through local testing, education and partnerships.

For more information about EndoPredict and its impact on tailored treatment decisions, please wisit the EndoPredict webpage. Link to EndoPredict EndoPredict® – Breast Cancer Diagnostic Test | Eurobio-Scientific

 

Eurobio Scientific

Eurobio Scientific is a global company with a mission to improve patients’ quality of life through specialty diagnostics. Our vision is to become a leading global specialty diagnostics company by offering highly innovative solutions to healthcare professionals to serve this purpose.

Con más de 370 empleados en todo el mundo, Eurobio Scientific se dedica a proporcionar apoyo local a través de nuestros cuatro centros de fabricación, tres centros de investigación y oficinas locales en Francia, Países Bajos, Alemania, Italia, Suiza, Reino Unido y Estados Unidos.

Nuestro experto equipo de I+D reúne años de experiencia en el desarrollo de pruebas avanzadas de diagnóstico molecular en los campos de los trasplantes, la oncología y las enfermedades infecciosas.

 

References:

1. National Institute for Health and Care Excellence (2024). Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer (Diagnostics guidance [DG58])
2. Filipits M. et al.: A New Molecular Predictor of Distant Recurrence in ER-Positive, HER2-Negative Breast Cancer Adds Independent Information to Conventional Clinical Risk Factors. Clin. Cancer Res. 2011
3. Sestak I. et al.: Prediction of chemotherapy benefit by EndoPredict in patients with breast cancer who received adjuvant endocrine therapy plus chemotherapy or endocrine therapy alone. Breast Cancer Res Treat. 2019
4. Filipits M. et al.: Prediction of Distant Recurrence using EndoPredict among Women with ER+, HER2- Node- Positive and Node-Negative Breast Cancer Treated with Endocrine Therapy Only. Clin Cancer Res. 2019