It can often be difficult for women to make reliable judgements in estimating their menstrual blood loss. In addition, feminine hygiene products have dramatically changed to wick blood away from the surface, obscuring visual assessments. Both of these factors have a large impact in clinical trials, where menstrual blood loss is the primary efficacy endpoint.
KCAS’ validated Alkaline Hematin method provides a scientifically based, quantitative measurement of blood loss for statistical comparison to standard of care. This lower sensitivity assay was established at the request of our sponsors needing to measure smaller amounts of blood representative of spotting. We performed side-by-side comparisons to determine the accuracy of pictograms (e.g., PBAC / PBLAC) for products currently on the market and our research found that pictograms are not only inaccurate, but lead to false conclusions regarding the inclusion or exclusion of subjects into a clinical study.
The assay involves placing samples into an alkaline extraction media and liberation of the heme moiety from hemoglobin with pummeling. The assay, referred to as Alkaline Hemtatin, has been automated with use of robotic systems and the use of 96-well assay format.
The importance of these assays is to objectively assess the efficacy of pharmaceutical and device treatments for reducing bleeding associated with idiopathic mennoraghia, fibroids, endometriosis and adenomyosis. This key clinical endpoint assay has been reviewed by the FDA and available under their master file.
KCAS presented the higher sensitivity Alkaline Hematin assay at the World Congress on Endometriosis (Vancouver, BC) on May 17-18th.
KCAS also attended American College of OB/Gyn (San Diego, CA) May 6-8.