NeoGenomics, Inc. announced that new data, being presented at the 45th Annual San Antonio Breast Cancer Symposium (SABCS) taking place on December 6-10, support the use of the RaDaR®Assay across all types of early breast cancer in both the adjuvant and surveillance settings. RaDaR is a personalized, highly-sensitive sequencing test for the detection of minimal residual disease (MRD) and recurrence. MRD is the trace amounts of circulating tumor DNA (ctDNA) that remain after surgery or other cancer treatment.

One study being presented is the c-TRAK TN trial, which compared the use of RaDaR to digital PCR (dPCR) in the surveillance setting in 161 patients with early-stage triple negative breast cancer (TNBC). Among ctDNA-positive patients, more than half (55.2%) were first detected by RaDaR versus 5.2% by dPCR. The use of RaDaR also was associated with a longer time between ctDNA detection and relapse (median lead time of 7.1 months with RaDaR vs 5.7 months with dPCR).

The c-TRAK TN study was selected as a spotlight poster presentation (Poster #PD5-03) and is being presented on December 7. Data presented in poster will be updated with analysis of additional patients from the study cohort. The second study includes preliminary data from a long-term prospective cohort study called TRACER, investigating the use of RaDaR in patients with early breast cancer across multiple subtypes. Samples were measured at baseline, during neoadjuvant chemotherapy, during surgery, and during post-surgical follow up.

Among the first 43 of 145 patients enrolled, RaDaR was highly sensitive, detecting ctDNA in 88% (38/43) of patients prior to them receiving neoadjuvant therapy and allowing for monitoring ctDNA dynamics during treatment and surgical periods as well as identifying patients with persistent ctDNA after receiving curative-intent therapy. During neoadjuvant therapy, the majority of patients experienced a rapid decline in ctDNA levels from baseline to cycles 4 or 5. In the surgical period, 94% (17/18) of patients with available specimens prior to surgery and 96% (27/28) with available samples post-surgery demonstrated ctDNA clearance. The TRACER study (poster #P6-01-16) will be presented on December 9 and will include data from additional patients in the cohort.