Accreditations

Boca Bio completed a targeted prospective Graves disease collection, recruiting 10 qualified donors and delivering high-viability PBMCs with detailed clinical data to support targeted HLA research.

Boca Bio supported a prospective longitudinal muscle-invasive bladder cancer (MIBC) study involving 45 participants, matched tissue and blood-based specimens, multiple collection timepoints, and fresh international specimen logistics.

Boca Bio completed a targeted prospective serum collection for rheumatic heart disease research in approximately two months—nearly one month ahead of schedule. The study included a highly defined RHD cohort and age- and sex-matched healthy controls, supported by detailed demographic and clinical data, including vaccination status.

Learn how Boca Bio successfully completed a prospective collection of 500 plasma specimens from healthy adults aged 60+ across six U.S. clinical sites. Discover how standardized plasma processing, multi-site clinical operations, and sponsor-specific protocols supported high-quality biospecimens for biomarker research.

Learn how Boca Bio helped a drug discovery company complete a chronic migraine biomarker study within two months through high-quality biospecimen procurement, multi-site patient recruitment, and precise sample handling that preserved biomarker integrity and improved operational efficiency.

Boca Biolistics supported a small biotech company in achieving FDA 510(k) clearance and CLIA waiver designation for a novel point-of-care diagnostic device targeting respiratory infections. Through a prospective comparative study conducted across six clinical sites, Boca managed both investigational product (IP) testing and predicate device validation within a unified workflow. The study enrolled 700 subjects […]

Boca Biolistics enabled rapid serum sample procurement for a global biopharmaceutical company conducting a vaccine trial, collecting 300 clinically annotated serum samples from immunized adults within four months across three U.S. sites. The study focused on subjects vaccinated within a 1–6 month window to capture critical immune response biomarkers, including cytokines and interferons. Leveraging prospective […]

This case study highlights how a global diagnostics company accelerated its clinical development program by partnering with Boca Bio to overcome operational bottlenecks. Facing delays from slow vendors, limited sample access, and rigid processes, the company required faster, more flexible clinical operations to meet critical FDA timelines. Boca Bio delivered rapid sample procurement, efficient laboratory […]

This case study highlights how a global top-three diagnostics company successfully scaled biospecimen access by partnering with Boca Bio. Facing challenges with inconsistent sample quality, delays, and limited access to rare disease specimens, the company needed a reliable solution to support assay development and regulatory submissions. Boca Bio leveraged its global biorepository and clinical network […]

This case study highlights the benchmarking of a respiratory PCR panel to support FDA submission by comparing its performance against an FDA-cleared reference assay. The study focused on key validation metrics, including limit of detection (LOD), sensitivity, specificity, and false positive/negative rates under real clinical conditions. Results demonstrated strong agreement with the reference method, confirming […]