Since 2006, KCAS has provided analytical support to companies developing treatments for menorrhagia (heavy menstrual bleeding), using the alkaline hematin assay. Clinical trials for drug therapies or surgical techniques treating menorrhagia, uterine fibroids (leiomyoma), or adenomyosis, often require reduction of menstrual blood loss (MBL) measured during or post-treatment, vs baseline at screening, as an endpoint. Unique in this field, in the past 12 years, KCAS has determined blood loss in more than 29000 menstrual cycles collected in support of Phase II and III clinical trials, leading to FDA approval of drug and device submissions that included Alkaline Hematin MBL data.
Using a rapid spectrophotometric technique, the KCAS alkaline hematin assay quantitates MBL on feminine hygiene products and offers an objective measure of blood loss compared to the highly subjective, inaccurate menstrual pictogram or PBLAC used in the past. The alkaline hematin assay was validated at KCAS to the principles of the current FDA Guidance on Bioanalytical Method Validation. Two assay LLOQs (low limit of quantitation) are offered:
- 1.0 mL, typically preferred when MBL must be reported for each day of bleeding as well as for the cycle as a whole
- 2.5 mL, preferable when reporting daily MBL is and only the total for the full cycle is reported.
The method involves pummeling used feminine hygiene products in extraction matrix and measuring the resulting alkaline hematin absorbance against a calibration curve prepared from the patient’s blood. Three levels of quality control sample are processed with each cycle and must meet typical bioanalytical method acceptance criteria as laid out in the FDA guidance on Method Validation. To facilitate rapid turnaround on results, Hamilton Liquid Handlers were introduced in 2016 for calibration curve preparation and plating.
Sanitary product samples have been demonstrated stable for up to 56 days under ambient conditions. They are accessioned, barcoded, tracked and reported in a validated database. Multiple reporting options include single Patient Cycle pdf file reports provided to the originating clinical site, data exports to Excel, and/or custom-defined export files uploaded into our customer’s data management system. Separate options exist for reporting of screening data, typically reported to the clinician and client, while not reporting treatment data, to blinded parties.
The KCAS Clinical Sample Kit (CSK) team provides complete collection kits internationally for alkaline hematin studies, including the validated sanitary product brands, containers and pre-labeled bags for collecting & storing used sanitary product, venipuncture supplies, detailed draft patient instructions ready to be submitted to IRB, a laboratory manual for the clinician and shipping labels, boxes and documentation. Click here for more information on kits for the alkaline hematin assay.
The Alkaline Hematin assay is acknowledged as the definitive MBL efficacy biomarker by regulatory agencies and recognized experts in the women’s health field and KCAS is the worldwide leading provider of this assay. KCAS offers a full service solution for the Alkaline Hematin Endpoint in clinical trials supporting menorrhagia treatments.
Be sure to contact us if you have a novel use for this assay that we can investigate together.