Request Expert / Similar Expert
Click “request expert” for a free initial screening call with this expert or a similar expert regarding your expert consulting needs
Summary
His Molecular Diagnostics expert focuses on analytical and clinical validation, regulatory readiness, and laboratory compliance. He brings over 20 years of experience supporting PCR- and NGS-based diagnostic platforms, including oncology assays and early cancer detection applications.
Anbu has direct experience supporting CLIA-based prostate cancer diagnostic testing programs, as well as leading quality and regulatory functions for high-complexity molecular diagnostics laboratories performing PCR and genomics-based testing at scale.
He specializes in independent oversight of assay development, including evaluation of study design, assessment of assay performance data, and identification of validation gaps to ensure alignment with CLIA/CAP high-complexity laboratory standards and FDA submission expectations. He is particularly effective in early-stage environments, helping organizations developing next-generation assays—such as prostate cancer diagnostics—ensure that their data packages are complete, scientifically defensible, and positioned for both regulatory approval and reimbursement.
Highlights
- Specialized in pressure testing analytical and clinical data packages
- Direct experience in prostate cancer molecular diagnostics (CLIA environment)
- “Hands-on” guidance on validation strategy, study design, and data integrity
- Ensures alignment with CLIA, CAP, FDA, and Medicare expectations
- Bridges R&D, Clinical, and Regulatory teams to accelerate submission readiness
- Molecular Diagnostics: PCR, NGS, Oncology Assays
- Study Design Evaluation & Clinical Validation Strategy
- Analytical Validation: LoD, Precision, Specificity, Reproducibility
- Assay Performance Data Review & Regulatory Defensibility
- Reimbursement & Medicare Alignment
Relevant Accomplishments
- Provided independent oversight of assay development programs, including evaluation of study design and validation strategy for molecular diagnostic assays
-
- Reviewed and assessed analytical and clinical performance data, identifying gaps in LoD, precision, specificity, and reproducibility prior to regulatory submission
- Delivered hands-on guidance to laboratory and R&D teams on required validation work, documentation, and quality controls to meet CLIA/CAP high-complexity testing standards
- Conducted comprehensive data package pressure testing, ensuring completeness, scientific rigor, and regulatory defensibility
- Supported oncology diagnostic programs, including assays relevant to prostate cancer and other solid tumors, across PCR and NGS platforms
- Strengthened alignment between validation data and reimbursement expectations (including Medicare) to support clinical utility and payer acceptance
- Established and optimized CLIA/CAP-compliant laboratory quality systems, ensuring inspection readiness and operational compliance
- Led regulatory and quality strategy for prostate cancer molecular diagnostic testing in a CLIA-certified laboratory environment
- Implemented and maintained FDA QSR/GMP, CLIA, CLEP, ISO 13485, ISO 15189, ISO 14971, ISO 27001, and MDSAP-compliant QMS
- Served as Management Representative for FDA and global regulatory agencies
- Led regulatory submissions including FDA 510(k), De Novo, PMA, and international filings
- Supported commercialization and lifecycle compliance of innovative diagnostic products focused on improving cancer management
- Led Quality and Regulatory Affairs for a CLIA-certified molecular diagnostics laboratory supporting high-throughput PCR and genomics-based testing
- Directed implementation of FDA QSR/GMP, ISO 13485, and CLIA-compliant quality systems across diagnostic platforms
- Supported development and commercialization of PCR- and genomics-based diagnostic assays, including oncology and early disease detection applications
- Provided regulatory and quality oversight for FDA EUA-authorized RT-PCR diagnostic assays, including validation and compliance activities
- Contributed to regulatory alignment and oversight of AI-enabled genomic data analytics platforms, supporting complex diagnostic workflows
Roles
- Independent Fractional VP, Quality and Regulatory Affairs
- Head of Regulatory Affairs & Quality Assurance (CLIA-Based Oncology & Molecular Diagnostics)
- VP, Quality & Regulatory Affairs (CLIA-Based Genomics & Molecular Diagnostics),
- Director, Quality & Regulatory Affairs
- Senior Quality Engineer
- Senior Manufacturing Engineer
Request Expert / Similar Expert
Click “request expert” for a free initial screening call with this expert or a similar expert regarding your expert consulting needs
To apply for this job email your details to haleymmagnani@gmail.com
