New Assay Determines if Bladder Cancer Patients Need Radical Surgery

The majority of patients suffering from muscle-invasive urothelial cancer face a high risk of recurrence, and most undergo cystectomy, resulting in the removal of the bladder. Now, a new assay tested in patients with muscle-invasive bladder cancer immediately following treatment with a combination of the immune checkpoint inhibitors in the neoadjuvant setting has demonstrated clinical potential for helping oncologists determine whether or not the patients need to undergo radical surgery.

The RaDaR assay from NeoGenomics, Inc. (Ft. Myers, FL, USA) 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. The study found that the absence of ctDNA in plasma - as detected by RaDaR - was associated with patient responses to treatment prior to surgery offering the possibility of avoiding aggressive surgery that removes the patient's bladder (also known as a cystectomy).

Image: The RaDaR assay determines whether or not muscle-invasive bladder cancer patients need to undergo radical surgery (Photo courtesy of NeoGenomics)

The RaDaR assay is a personalized, tumor-informed, highly sensitive technology that tracks a set of up to 48 tumor-specific variants in cell-free DNA (cfDNA) within a cancer patient's blood plasma. Built on the InVision platform, the personalized RaDaR assay has been designed to detect MRD following curative intent or definitive treatment, and early signs of relapse, and has been validated for clinical use in breast, colorectal, head and neck, as well as lung cancers. The RaDaR assay is a laboratory developed test (LDT) which has been granted Breakthrough Device Designation by the US FDA for use in the detection of MRD in early-stage cancer patients and has received the CE mark for the detection of MRD and recurrence.

"Although cisplatin-based chemotherapy plus radical cystectomy remains the currently recommended treatment for muscle-invasive bladder cancer, there are some patients who are not eligible to receive chemotherapy and the prognosis for this patient population is poor," said Shashikant Kulkarni, Chief Scientific Officer, NeoGenomics. "The findings from the NABUCCO trial offer initial evidence in hopefully improving the outlook for these patients. Importantly, the research shows that the RaDaR assay can be used successfully to guide decision-making and help oncologists personalize patient care based on their risk of recurrence."

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NeoGenomics, Inc.