NeoGenomics, Inc. ( NASDAQ: NEO ) fell 7% Friday morning after the cancer-focused lab operator announced that additional clinical data would be required to secure Medicare coverage for its RaDaR assay as a diagnostic test for colorectal cancer (CRC).
RaDaR is a laboratory-developed test (LDT) designed to detect minimal residual disease (MRD) and cancer recurrence using a patient's blood plasma.
According to the company, following discussions, MolDX cited the requirement for additional clinical data late last week, specifically pointing to a direct comparison with other MRD tests or a full clinical trial.
Due to robust published data, in the wake of the update, NeoGenomics ( NEO ) has decided to target its efforts on commercialization and reimbursement for RaDaR in breast cancer.
The company expects to seek an accelerated commercial launch of RaDaR for breast cancer in Q1 2023 and launch the test for CRC in the first quarter while broadening the clinical studies to support Medicare and other reimbursements.
We "look forward to promoting the assay through a controlled launch for both breast and colorectal cancer early next year," Chief Executive Chris Smith remarked.
Seeking Alpha contributor Hummingbird Insights LP reiterated the Hold rating on NeoGenomics ( NEO ) in September, noting that the ~75% YTD loss in its shares price justifies the lack of clarity in its outlook.
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NeoGenomics falls after update on Medicare coverage for cancer test