Clinical trials for drug therapies or surgical techniques treating menorrhagia, endometriosis, uterine fibroids, or adenomyosis, often require menstrual blood loss (MBL) measured at screening and post-treatment endpoints as an efficacy marker. KCAS has validated the alkaline hematin biomarker, a rapid spectrophotometric assay, acknowledged as the definitive MBL efficacy biomarker by regulatory agencies and recognized experts in the women’s health field.
The method involves pummeling used feminine hygiene products in a solution and measuring the resulting hematin absorbance against calibration curves. To allow us to rapidly reports results, the historic method was re-tooled and validated in accordance with current FDA Guidance for Method Validations. Please view the alkaline hematin assay performance sheet for additional information on the method type, analytical range and stability data.
We performed side-by-side comparisons to determine the accuracy of pictograms (e.g., PBAC) 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 alkaline hematin technique deﬁnitively and quantiﬁably determines MBL, and is commonly used for women’s health clinical trials as an MBL endpoint for:
- Uterine Fibroids
Our Clinical Sample Logistics team facilitates all aspects of the alkaline hematin project, including:
- Generating a custom laboratory manual and patient instructions
- Presenting site training at investigator meetings
- Creating sample collection kits
- Providing storage containers, shipping containers and shipping materials to clinical sites
- Coordinating re-orders and available for on-demand clinical site support
We utilize a custom Access/SQL database for data management and reporting that incorporates the unique aspects of multi-site AH clinical trials. The database’s specific report format and frequency is tailored to the client’s specific study design and needs.
Why Choose KCAS?
- Experience: Since 2006, KCAS has measured more than 137,000 samples from more than 10,000 menstrual cycles. Our method is validated to FDA Guidance for Validations standards, has been audited by both device and pharma clients.
- Logistics: No other lab has the know-how to help you design and facilitate the collection of AH samples across multiple domestic or international clinical sites.
- Proven Record: Our alkaline hematin data has been a part of multiple NDA submissions that met FDA approval. KCAS has supported several programs for drugs and devices and our data complies with FDA expectations.
KCAS continues to explore our proprietary techniques’ application in other areas. Be sure to contact us if you have a novel use for this assay that we can investigate together.
Interested in learning more about KCAS’ alkaline hematin assay? Fill out the form below and we’ll be in touch shortly!