Crescent’s trials have been designed to ensure the results will meet all relevant clinical and regulatory standards in the US and EU. We are currently conducting clinical trials in partnership with leading clinicians, universities and companies both in the US and the EU to further validate BQT® as a screening tool with a view to obtaining CE mark and FDA approval.
Retrospective Cohort Studies
Crescent recently completed a pilot retrospective cohort study in collaboration with a leading US clinic and medical school. This study was equivalent to a 2,500 participant study conducted over a 20-year follow-up period. Archived toenail clippings from postmenopausal women were analyzed for 82 women with a hip fracture up to 20 years after nail collection, as well as 81 age-matched controls. BMI, age, smoker status and hormone use were used as clinical risk factors in the model. The results, which are currently being prepared for publication, were extremely positive and establish the clinical validity of our test.
To provide further evidence and clinical validity, Crescent is currently completing several retrospective cohort studies using bio-banks from Europe and North America. Crescent is also expanding the scope of our clinical research to include male subjects.
Drug Response Studies
Crescent is actively seeking to participate in drug response studies to demonstrate that BQT® fracture risk test is also able to measure changes in nail structure based on exposure to bone active medications.
To find out more about our progress, or to discuss potential collaborative opportunities please contact us.