Breast Cancer LDT Test

Risk stratification of early-stage breast cancer is an active area of research and several commercially available products that are based on genotypic classification. A vexing issue in breast cancer is carcinoma in situ – which has no metastatic potential. There are two sub types – Ductal Carcinoma in Situ (DCIS) and Lobular Carcinoma in Situ (LCIS). The incidence of these entities is rising dramatically in the U.S. due to widespread mammography and the adoption of MRI which has led to dramatic increase in the incidence rates of carcinoma in situ.

Using its live tumor cell platform, Cellanyx has conducted an evaluation of approximately 60 breast cancer samples obtained from patients undergoing radical surgery (either mastectomy or lumpectomy). This initial clinical study has established analytical performance metrics for a live cell LDT for breast cancer patients. The Cellanyx breast LDT is intended to help stratify patients with DCIS or LCIS, who may not need aggressive surgical and/or radiation treatment and has potential to augment the standard pathology tests to improve risk stratification of the cancer aggressiveness.

Other Tumor Types

The Company has also generated preliminary clinical proof-of-concept data in tumor samples obtained at the time of radical surgeries in patients with renal, bladder and non-small cell lung cancers. These data support the potential for additional laboratory developed tests (LDTs) for these cancers following additional clinical studies.