Visby Medical Sexual Health Test receives FDA 510(k) clearance and CLIA Waiver
Vision Clinical Research (VCR) announces the FDA clearance and CLIA Waiver of the Visby Medical Sexual Health Test. The test incorporates a rapid single-use polymerase chain reaction for simultaneous determination of sexually transmitted infections caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis using samples extracted from self-collected vaginal swabs in females age 14 and above. VCR designed and executed early pilot studies as well as one of two pivotal studies providing evidence of safety and efficacy for the 510(k) clearance and CLIA waiver grants. VCR also provided protocol design, regulatory counsel, and statistical guidance to the second pivotal study executed under a grant from the National Institute of Allergy and Infectious Diseases within the National Institutes of Health.
Vision Clinical Research in Collaboration with Qualigen Therapeutics on QN-247 for Oncologic Indications
Working in collaboration with Qualigen Therapeutics, Inc., Vision Clinical Research is leading the development and pre-clinical efforts on an investigational drug candidate with the potential to treat a variety of different cancer types, including liquid and solid tumors. QN-247 is a DNA aptamer conjugated to a gold nanoparticle, which gives it increased potency and versatility. Preclinical studies in breast cancer with QN-247 showed significant cell inhibition activity. The broader versatility conferred by linking the aptamer to a gold nanoparticle includes such uses as enhanced radiation therapy, tumor imaging, and the delivery of other anti-cancer compounds directly to tumor cells.
KDx Diagnostics, Inc. Receives Breakthrough Status for Investigational URO17® Bladder Cancer Test and Initiates Pivotal Studies with Vision Clinical Research
Working with Vision Clinical Research (VCR) clinical, statistical, and regulatory resources, KDx Diagnostics applied for and received breakthrough status for their URO17 Bladder Cancer Test. The test is intended for use as a noninvasive method for initial diagnosis of bladder cancer in patients with hematuria, and for subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer in conjunction with other clinical diagnostic methods. Working with KDx and clinical advisors, VCR designed and powered pivotal studies in both indications and is in process of executing the studies for eventual regulatory submissions. In collaboration with KDx, VCR has also designed and is in process of executing analytical performance studies of the test to demonstrate method robustness.
Vision Clinical Research in COVID-19 Rapid Test Studies
Vision Clinical Research has worked with multiple sponsors to design, execute, analyze, and report analytical and clinical studies resulting in Emergency Use Authorizations (EUAs) for rapid detection of the SARS-CoV-2 virus responsible for COVID-19. The tests may be used for CLIA moderate and CLIA waived environments including testing at the point of care (POC).
Access Bio, Inc. CareStart™ Flu A&B Plus Rapid Point-of-Care Test FDA 510(k) Clearance
Vision Clinical Research (VCR) announces the FDA clearance of the Access Bio, Inc. CareStart Flu A&B Plus Rapid Point-of-Care test. The CareStart™ Flu A&B Plus is an in vitro rapid immunochromatographic assay for the qualitative detection of influenza virus type A and B nucleoprotein antigens directly from nasopharyngeal swab specimens of symptomatic patients. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and B viral infections. This test is intended to distinguish between influenza type A and/or B virus in a single test. This test is not intended to detect influenza type C viral antigens. Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not be used as the basis for treatment or other patient management decisions.
VCR co-designed the pivotal study protocol and reproducibility protocol, generated clinical study materials, selected and contracted with the investigational sites, developed the electronic data capture (EDC) system, trained and monitored the sites, performed statistical analysis, authored the clinical study report, and corresponded with FDA during the review process as necessary.
Spirosure (now Caire Diagnostics) Fenom Pro™ FDA 510(k) clearance
VCR announces the FDA clearance of the Spirosure Fenom Pro™ medical device. The Fenom Pro nitric oxide test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. FeNO is increased in some airway inflammation processes, such as asthma, and often decreases in response to anti-inflammatory treatment as an indication of therapeutic effect in patients with elevated FeNO levels. FeNO measurements are used as an adjunct to established clinical assessments. Fenom Pro is suitable for children, approximately 7-17 years, and adults 18 years and older. Testing with the Fenom Pro is performed in point-of-care healthcare settings under professional supervision.
VCR co-designed the two pivotal study protocols, generated clinical study materials, selected and contracted with the investigational sites, developed the electronic data capture (EDC) system, trained and monitored the sites, performed statistical analysis, authored the clinical study reports (CSRs) for both studies, and corresponded with FDA during the review process as necessary.
Sandstone Diagnostics Trak® FDA 510(k) clearance
VCR announces the FDA clearance of the Trak® Male Fertility Testing System. The Trak Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration as a factor that could impact a man’s fertility status and time to pregnancy. The device is for over-the-counter home use. VCR designed the pivotal study protocol, generated all study materials, selected and contracted with the investigational sites, developed the data capture forms, trained and monitored the sites, performed statistical analysis, authored the clinical study report (CSR), and corresponded with FDA during the review process as necessary.
EPIC Sciences CTC Liquid Biopsy Blood Collection Kit CE Mark
VCR announces the CE Mark certification of the Epic Sciences CTC Liquid Biopsy Blood Collection Kit for the collection and transportation of whole peripheral blood to be processed for laboratory testing. VCR guided Epic in generation of quality system documentation, authored the Technical File, identified the European Authorized Representative, and represented EPIC as necessary with sub-contractors.