Breaking News

NEW!! VBC is delighted to announce the FDA 510(k) Clearance of the Sandstone Diagnostics TRAK Male Fertility Testing System for home use. Vision Clinical Research (CRO subsidiary of VBC) co-authored the protocol (including generation of all statistical analysis methods and powering), designed CRFs and all other study-related documents, trained, managed, and monitored clinical study sites, analyzed the clinical study data and wrote the Clinical Study Report, guided analytical performance testing, and responded to requests for additional information from FDA.

NEW!! VBC is delighted to announce the FDA 510(k) Clearance of the Qualigen FastPack High-Sensitivity C-Reactive Protein Immunoassay for the assessment of inflammation in otherwise healthy individuals. VBC performed statistical analyses, authored the submission, and responded to requests for additional information from FDA.

NEW!! VBC is delighted to announce the FDA 510(k) Clearance of the Sequenom/Agena MassArray instrument and Factor II/Factor V Leiden genotyping test for thrombophilia. VBC performed statistical analyses, authored submission sections, guided the company project team regarding regulatory considerations, and responded to requests for additional information from FDA.

NEW!! VBC is delighted to announce the FDA 510(k) Clearance of the Qualigen FastPack Vitamin D Immunoassay for the assessment of Vitamin D sufficiency in adults. VBC performed statistical analyses, authored the submission, and responded to requests for additional information from FDA.

NEW!! VBC is delighted to announce the FDA 510(k) Clearance of the Qualigen Multi-Analyte Control for the verification of accuracy and precision of FastPack assays for Free Thyroxine, Human Chorionic Gonadotropin, Testosterone, Total Prostate Specific Antigen, and Thyroid Stimulating Hormone. VBC authored the submission and responded to requests for additional information from FDA.

NEW!! VBC is delighted to announce the FDA Pre-Market Approval (PMA) of the Gen-Probe PROGENSA PCA3 molecular urine test indicated for use along with other patient information to assist in the decision for repeat prostate biopsy in men aged 50 or older who have had one or more previous negative biopsies. VBC guided the regulatory pathway, collaborated on design of the pivotal prospective clinical study, performed sample size analysis and guided the statistical analysis plan, authored the clinical study report, and interacted with the Agency during several pre-IDE meetings.

NEW!! VBC is also delighted to announce the FDA 510(k) Clearance of the Iris Molecular Diagnostics ProsVue test to be used as a prognostic marker in conjunction with clinical evaluation as an aid in identifying those patients at reduced risk for recurrence of prostate cancer for the eight year period following prostatectomy. VBC collaborated on design of clinical and analytical studies, performed all statistical analyses, authored the clinical study report and sections of the regulatory submission, interacted with the Agency during several face-to-face and teleconference meetings, and responded as necessary during the review period.

VBC is also proud to announce the FDA approval of Cadence Pharmaceuticals OFIRMEV (acetaminophen injection) for pain management; the FDA clearances of the Qualigen FastPack TSH and Testosterone tests; the European Medicinal Agency approval of Ceplene (histamine dihydrochloride) for acute myelogenous leukemia; the 510(k) Clearances of new rapid tests for C-Reactive Protein, and Magnesium; the FDA 510(k) Clearance of the Qualigen FastPack beta-hCG Test for early detection of pregnancy; the 510(k) Clearances for the immuno- and turbidimetric inhibition assays of the diaDexus Plac Test for lipoprotein-associated phospholipase A2 to be used as a risk factor for cardiovascular disease and ischemic stroke; the FDA Approval for the Santarus Omeprazole/Sodium Bicarbonate Drug Product, Zegerid, for treatment of active duodenal ulcer, gastroesophageal reflux, upper gastrointestinal bleeding, and erosive esophagitis; the IND Approval for the OncRes organ rescue agent (1% Uracil Ointment) for patients with Breast Cancer; the 510(k) Clearance for the Applied Imaging Her-2/neu FISH assay; the 510(k) Clearance and CLIA Waiver for the ReliaLAB Lithium assay; AND the 510(k) clearance and CE Mark certification for the Toyota Tsusho America GlycoMark test for 1,5-anhydroglucitol to be used in intermediate term monitoring of glycemia.

About Us

Vision Biotechnology Consulting is a premiere biotechnology consulting firm. Our mission is to assist pharmaceutical, device, and diagnostic firms in product design, development, clinical trials, regulatory affairs, biostatistical analysis, manufacturing, and patent application drafting and prosecution. VBC's staff has brought 42 products (8 drugs, 34 in vitro diagnostic tests) successfully to market approval or clearance in the oncology, cardiovascular, diabetes, endocrine, infectious disease, rheumatology, urology, gastroenterology, metabolic bone disease, and reproductive hormone fields. VBC has also achieved CE Mark certification for two in vitro diagnostic products.

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