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 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 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 |