Delphi Diagnostics

Delphi Diagnostics guides personalized breast cancer therapy decisions with SET.

Home » Our Technology » Breast Cancer Diagnostic Tests

Breast Cancer Diagnostic Tests

SETER/PR Index is an endocrine-related transcriptional gene signature. This is our core technology.

  • Selected genes representing endocrine-receptors activity are measured in a breast cancer sample (Symmans et al. 2010) to yield the SETER/PR index score.
  • Routinely preserved clinical tumor samples from core biopsy, fine-needle aspirate, or surgical resection can be used.
  • Provides independent prognostic information in patients treated with adjuvant hormone therapies.
  • A high SET score is associated with good prognosis on endocrine therapies.

SET2,3 Test

SET2,3 breast cancer test

SET2,3 is an assay that provides therapeutic insights on Stage II-III invasive breast cancer with nodal involvement.

  • SETER/PR is determined from the tumor sample and the index score is adjusted for baseline prognosis using clinical factors (tumor size, nodal status) and molecular subtype genes (RNA4).
  • SET2/3 provides prognostic information independent of adjuvant and neoadjuvant chemotherapy response (Du et al. 2021).
  • Currently implemented on a highly reproducible multiplex platform, validated across multiple laboratories (Bossuyt et al. 2021).

SET4 Test

SET4 breast cancer test

SET4 is an assay that employs SETER/PR in the metastatic setting and is one of the only gene signatures that has shown prognostic efficacy in Stage IV breast cancers.

  • Higher SETER/PR score was associated with longer progression-free and overall survival in Stage IV patients treated with endocrine therapy (Sinn et al. 2019).
  • Implementation with advanced design on next generation RNAseq (Fu et al. 2021) allows interrogation of relevant mutational hotspots. 
  • SET4 is in the process of completing pre-clinical validation.

Patents

The following Delphi Diagnostics, Inc. products may be covered by one or more patents as indicated below:

Notice is hereby provided under 35 U.S.C. §287(a) for the following products:

SETER/PRTM The listed products and their use are the subject of US Patent Nos.:
US 11,459,617
SET2,3 TM The listed products and their use are the subject of US Patent Nos.:
US 11,459,617