About
Bay Area Biostatistics Associates have experience working on more than 30 approved FDA and CE mark assays
Medical Statisticians with more than a decades experience.
Experience working with assays and systems at Roche Molecular Diagnostics, Roche Sequencing Solutions, BD Diagnostics, Novartis Diagnostics, Applied Biosystems and other clients.
Recent Work
- Coronavirus disease (COVID-19) assays for both high throughput labs and CLIA waived tests for point-of-care (POC) instruments located in doctors offices, emergency rooms, drive-through testing sites, and Pharmacies.
- Sequencing Assays for tumor tissues using next generation sequencing on the illumina Platform.
- Emergency Use Authorization (EUA) for an FDA Center for Biologics Evaluation and Research (CBER) approved zika virus assay for US blood screening; When a potential emerging outbreak appeared in Florida putting pregnant women at risk.