New guidance from the National Institute for Health and Care Excellence (NICE)¹

The National Institute for Health and Care Excellence (NICE) in the UK has issued a new guidance, endorsing the use of EndoPredict^®, a cutting-edge diagnostic tool to support healthcare providers to make decisions on the use of chemotherapy in patients with lymph node positive early ER+ HER2- breast cancer.

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. “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:
  • They have an intermediate risk of distant recurrence using a validated tool.
  • 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 Myriad Genetics, 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 check the white paper.

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. Clin. Cancer Res. 2011
3. Sestak I. et al. Breast Cancer Res Treat. 2019
4. Filipits M. et al. Clin Cancer Res. 2019