NeoGenomics has received expanded Medicare coverage for its RaDaR® ST molecular residual disease (MRD) assay to include monitoring of treatment response to immune checkpoint inhibitor therapy in patients with late-stage solid tumours.

The coverage was granted through the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostic Services Program (MolDX). It represents the third Medicare-covered indication for RaDaR ST, which is also covered for patients with HPV-negative head and neck squamous cell carcinoma and a subset of hormone receptor-positive (HR+), HER2-negative breast cancer.

Immunotherapy is widely used to treat solid tumours including lung cancer, melanoma, bladder cancer and renal cell carcinoma. However, imaging can sometimes make it difficult to distinguish treatment response from inflammation-related changes known as pseudoprogression. Longitudinal molecular testing can provide additional information on disease progression and treatment response during therapy.

RaDaR ST uses a personalised, tumour-informed approach to analyse up to 48 patient-specific variants identified through whole-exome sequencing. The assay is designed to detect circulating tumour DNA (ctDNA) at very low levels and can be used for recurrence-risk assessment, disease monitoring after treatment and tracking response during systemic therapy.

Evidence supporting the use of RaDaR ST for immunotherapy monitoring has been reported across several cancer types, including melanoma, head and neck, breast and bladder cancers. Studies have also shown associations between ctDNA changes and treatment response and survival in patients with advanced head and neck cancer receiving immune checkpoint therapy.

NeoGenomics has two additional RaDaR ST submissions currently pending review under the MolDX programme.

 

Source: businesswire.com

Report Abuse