MolDX Expands Medicare Coverage of NeoGenomics RaDaR ST to Immunotherapy Monitoring

NeoGenomics said on Wednesday that Medicare's Molecular Diagnostic Services Program (MolDX) has expanded coverage of its RaDaR ST molecular residual disease (MRD) blood test to include monitoring how patients with late-stage solid tumors respond to immune checkpoint inhibitor therapy.

According to the company's announcement, distributed by Business Wire, it is the third Medicare-covered indication for RaDaR ST. The test was already covered for HPV-negative head and neck squamous cell carcinoma and for a subset of hormone receptor-positive, HER2-negative breast cancer. The company said it has two more RaDaR ST submissions pending with MolDX.

Coverage route

NeoGenomics said the coverage is provided under the MolDX local coverage determination "Plasma-Based Genomic Profiling in Solid Tumors" (L38043). The LCD, posted on CMS's Medicare Coverage Database, is a limited coverage policy for next-generation sequencing tests performed on cell-free DNA in plasma, which it calls liquid biopsies. It lists Palmetto GBA among the Medicare Administrative Contractors that apply it.

The company did not disclose a price or the Medicare payment rate for the test in the announcement, and did not say which further indications are under review.

The test and the company's case

RaDaR ST is tumor-informed: it uses whole-exome sequencing of a patient's tumor to pick up to 48 patient-specific variants, then looks for those variants as circulating tumor DNA (ctDNA) in blood. NeoGenomics says the test supports recurrence-risk assessment after curative-intent surgery, recurrence monitoring during surveillance, and treatment-response monitoring during systemic therapy. The company reports a 95 percent limit of detection at 11 parts per million and detection down to 1 part per million under study-specific conditions, citing its own data on file.

In its announcement, NeoGenomics argued that imaging alone often cannot reliably separate true response from treatment-related inflammation, known as pseudoprogression, during immunotherapy, and said repeated molecular testing may help identify early signs of progression. It cited published studies of the test in melanoma, head and neck, breast and bladder cancers, including a head and neck cancer study in which it said ctDNA dynamics tracked with survival and response to immune checkpoint blockade.

"We view this coverage determination as a cornerstone of our launch of RaDaR ST," Chief Executive Tony Zook said in the release. He added that the company continues "to anticipate further reimbursement decisions to support growth in the coming years."

Clinical Lab Products reported the coverage expansion on August 27, describing it as covering monitoring of response to immune checkpoint inhibitor therapy and noting the two pending submissions.