A Wearable In-pad Diagnostic for the Detection of Disease Biomarkers in Menstruation Blood

The pain-free regular monitoring of blood-based biomarkers is a highly appealing yet difficult-to-realize approach for the early detection of pathological changes, including cancers, infections, or metabolic diseases, such as diabetes. While a major focus of the research community lies on the investigation of pain-free blood sampling and devices for venous blood analysis, menstruation blood remains a largely ignored sampling source. Growing evidence shows excellent correlation between biomarker levels in menstruation blood and venous blood for an entire clinical panel of analytes. Here, we introduce a wearable, microfluidic diagnostic platform integrated into standard hygiene pads for the electronic-free naked eye-readable direct detection of disease biomarkers in menstruation blood (MenstruAI). We demonstrate semi-quantitative biomarker detection from menstruation using infection and inflammation biomarker C-reactive protein (CRP), gynecological cancer biomarkers (CEA and CA-125), and endometriosis biomarker CA-125 as representative examples of relevant proteinaceous biomarkers. The color-changes induced by the presence of these biomarkers can be read-out by the naked eye as well as by a machine-learning algorithm implemented into a smartphone-app, enabling semi-quantitative analysis. The presented MenstruAI platform has the potential to revolutionize women's health by providing a non-invasive, affordable, and accessible approach to health monitoring, potentially democratizing healthcare by making health services more available and equitable. ### Competing Interest Statement Lucas Dosnon and Inge K. Herrmann declare inventorship on a patent application filed by ETH Zurich and Empa on the in-pad menstruation blood analysis platform (L. Dosnon, I.K. Herrmann, A device for detection of biomarkers, EP23209241). ### Funding Statement This study did not receive any funding ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The collection of venous (BASEC No. 2016-00816) and menstruation blood (BASEC No. 2023-00562) was approved by the cantonal ethics commission of the Canton of St. Gallen, Switzerland. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors