Breast Cancer Recurrence Risk Assessment

Transcriptome Gene Expression Testing for Breast Cancer

Background

U.S. Success Story
In 2005, Genomic Health introduced the 21-gene breast cancer recurrence score test.
  • The test has served 2 million patients with HR+, HER2-, N0 early breast cancer in the United States.
  • Approximately 600,000 (30%) low-risk patients were identified through screening to avoid ineffective chemotherapy.
  • The reported savings in chemotherapy drug costs for the healthcare system were RMB 300 billion.
Recommended by Guidelines
  • The NCCN breast cancer treatment guidelines list the 21-gene test as a recommended molecular test.
  • Ten-year follow-up data show that the recurrence score of 21-gene testing has been extremely successful.
Rapid Growth

Other similar products such as 70-gene, 50-gene and 12-gene have been clinically applied in western developed countries, and some of them have been introduced to China through agents.

Clinical need

Luwei aims to address the gap in products for Asian populations through clinical validation and wider adoption.

Product Line

1. RNA expression detection in hormone receptor-positive early-stage breast cancer patients
The tests help determine whether patients with HR+, HER2-, N0 early breast cancer need chemotherapy and how they may respond to chemotherapy or endocrine therapy.

a. Recurrence score (21 genes)

b. Chemotherapy response score (20 genes)

c. Endocrine therapy response score (23 genes)

2. RNA expression detection in patients with triple negative breast cancer (TNBC)
The tests help assess whether patients with triple-negative breast cancer need chemotherapy and how they may respond.

a. Recurrence score (16 genes)

b. Chemotherapy response score (19 genes)

Technical advantages

  • The technical lead is a core member of Genomic Health’s U.S. 21-gene breast cancer recurrence score team. Independent research and development took more than four years, with a number of invention patents.
  • The original model based on the re-optimization of the Asian population applies the latest scientific research results in the field of breast cancer molecules.
  • Based on NGS sequencing, the number of modeling samples is larger, and the gene screening and modeling algorithm of independent patent is used.

Tests and performance

Cancer type Prognosis Specificity Sensitivity AUC 5-year survival rate Use
Low risk
HR+, HER2-, N0 Recurrence score (RS) 79% 78% 0.85 97% Low-risk patients avoid chemotherapy.
Response to chemotherapy 89% 88% 0.94 90% Chemotherapy for patients with high response scores.
Response to endocrine therapy 89% 85% 0.93 85% Endocrine therapy for patients with high response scores.
Triple-negative breast cancer (TNBC) Recurrence score (RS) 91% 95% 0.96 90% Aggressive treatment for high-risk patients, such as high-dose chemotherapy; Low-risk patients are treated conservatively.
Response to chemotherapy 94% 95% 0.98 88% Chemotherapy or high-dose chemotherapy for patients with high response scores; For patients with low response scores other treatment options, chemotherapy regimens should be used with caution.
Single gene or combination gene expression PARP1, ATR, ATM, ER, PGR, HER2, MKI67, BRCA; PI3K, AKT, mTOR, PI3KCA; CDK4, CDK6; VEGF, TACSTD2, PD-1, PD-L1 etc. Medication guidance