Molecular Diagnostics and Genomic Medicine are the most dynamic fields in Pathology, maybe in all of medicine. This also makes it difficult to stay current with new biomarkers, drugs and guidelines.

In the laboratory, technical advancements continue to be a challenge. Selecting an appropriate assay or technology to provide clinically actionable biomarker testing is a multifaceted issue that needs to include current capabilities and future needs. And with these advances come changes in the regulatory environment. The FDA has approached Congress about developing a new regulatory system to allow the FDA to review laboratory developed tests and procedures. The Centers for Medicare and Medicaid Services (CMS) has empowered the MolDx program at Palmetto GBA to review and approve for Medicare reimbursement the molecular assays that cover nearly 70% of the Medicare population. Third party payers continue to struggle with understanding the implications and especially the benefits of molecular and genomic medicine.

Clinical Molecular and Genomic Consulting LLC is available to assist in several of these areas. Expertise in CLIA molecular laboratory operations and experience in clinical assay development for assay vendors. Assistance for third party payers on the continuing growing importance of molecular and genomic analysis for patient care.