Abstract - TBD

Abstract - TBD

Abstract - TBD

In this session, we will discuss the current status of reimbursement for liquid biopsy technologies in the US with a focus on coverage, coding, and payment for NGS biomarker panels.  This will include a review of recent changes to Medicare coverage both within and outside of the Mol Dx program.  We will also examine novel CPT coding options including Cat I and PLA and their associated payment rates on the clinical lab fee schedule. Finally, we will describe the possible future of reimbursement for liquid biopsy tools and touch on how reimbursement may evolve for emerging technologies such as MRD and early cancer detection tools.

Abstract - TBD

Abstract TBD

Abstract - TBD

Abstract - TBD

It has already been established that it is now possible to produce a comprehensive genomic profile for myeloid malignancies in as little as 24 hours using the Myeloid Gx assay run on the Genexus Integrated Sequencer. I will present data to demonstrate how it is now also possible to produce a comprehensive genomic DNA profile for lymphoid malignancies using the Liverpool Lymphoma Network Ampliseq Community Panel run on the Genexus Integrated Sequencer. I will also present data showing how the Oncomine Childhood Cancer Research Assay might be used to produce a rapid genomic DNA and RNA profile for high grade lymphoid malignancies such as B-ALL, T-ALL and DLBCL.

Mucosa-associated lymphoid tissue (MALT) lymphomas are slow-growing B-cell lymphomas mainly diagnosed in the stomach and termed gastric MALT lymphoma (G-MALT). Despite histological evaluation, immunostaining, and additional B-cell clonality analysis by fragment analysis, a clear-cut diagnosis is not feasible in all cases, especially for clinical follow-up of patients after treatment. We examined clonally rearranged immunoglobulin heavy- and light-chain gene sequences of 36 genomic DNA samples from six different patients obtained at different time points over the course of several years using a B-cell receptor pan-clonality next-generation sequencing (NGS) assay. Each case consisted of samples diagnosed with G-MALT and samples without evidence of lymphoma, based on histological examinations. We show a robust correlation (100%) of the results between the applied NGS method and histology-diagnosed G-MALT-positive patients. We also detected malignant clonotypes in samples where histology assessment failed to provide clear evidence of G-MALT (15 out of 19 samples). Furthermore, this method revealed malignant clonotypes much earlier in the disease course, with NGS of the immunoglobulin light chain being crucial in complementing immunoglobulin heavy-chain analysis. Hence, the value of NGS in routine lymphoma diagnostics is greatly significant and can be explored in order to provide better diagnoses and proffer the early detection of lymphoma relapse.