Prosigna‌™ test for breast cancer Israeli Laboratory of Experimental Medicine (LEM) has begun conducting a one-of-a-kind molecular analysis called Prosigna‌™ test, the purpose of which is to evaluate the likelihood of cancer recurrence. It is based on an algorithm, which is calculated accordance to following criteria:

 

  • Gene signature (PAM50)
  • Biologic subtype of tumour
  • Tumour size
  • Lymph node involvement
  • Assessment of tumour development

Multiple studies, clinical trials' results and publications in scientific journals support the importance of gene expression analysis for the purpose of classifying breast cancer, in order to determine prognosis and optimal course of treatment in early-stage breast cancer patients.

The Prosigna‌™ Technology

The test is performed using the advanced nCounter system, manufactured by Seattle-based NanoString Technology, a company that specializes in development of molecular-genetic tests and diagnostics tools.

Advantages

The Prosigna‌™ test is considered to have the following advantages over other prognostic tests for breast cancers:

  • Approved by both the FDA and CE
  • Assesses likelihood (in %) of recurrence in patients with early-stage breast cancer within 10 years of diagnosis
  • Accuracy clinically proven
  • Only test capable of determining a cancer's molecular subtype (luminal A, luminal B, basal-like, HER2)
  • The Prosigna‌™ assay divides patients into three risk groups: low, intermediate and high
  • Patients are referred by their treating oncologist or surgeon for the purpose of determining optimal medical treatment. The test will tell whether chemotherapy (in addition to hormonal therapy) is needed

It is important to note that:

  1. Results are available within 4 days
  2. The testing is performed on tumour tissue obtained during surgery; it takes place at LEM Laboratories in Israel. LEM has been certified to perform this test by Israel’s Ministry of Health

Indications

The Prosigna‌™ test is intended for female patients, who were diagnosed with early-stage receptor-positive breast cancer and had undergone either a mastectomy or an organ-sparing operation (lumpectomy).