Point-of-Care Cervical Cancer Screening Device
CerMark™ is a rapid, self-contained, point-of-care cervical cancer screening system designed to detect proteins indicative of HPV as well as cellular changes resulting from HPV integration into the host cell genome associated with transformation. The complete system consists of a patient-sample-preprocessing (PSP) unit for rapid sample preparation, integrated with a disposable, point-of-care, microfluidic cartridge employing an array of carbon nanotube electrodes. The cartridge is used in conjunction with a battery driven, multi-cartridge, portable instrument designed to support cartridge function, quantitatively analyze signals produced on the array, and interpret results through an embedded algorithm providing the user with a simple output reflecting cervical screening status.
This device detects multiple, unique biomarkers associated with cervical disease and infection at different states of progression in minutes. The quantitative, multiplex detection of biomarkers interpreted by the CerMark™ system leads to a higher level of sensitivity and specificity than occurs with a single biomarker. The system is used at the point of care and is applicable in developing countries around the world that may be deficient in laboratory infrastructure or trained personnel typically required for Pap screens. The separation of the patient, sample and test is minimal and the patient does not need to return for the results optimizing appropriate and timely progress through the medical system.
Target biomarkers chosen for inclusion in CerMed’s screen have been repeatedly proven to correlate very highly with the presence of high risk cervical lesions resulting from HPV infection. CerMed is advancing development of its protocol for cervical screening from the macroscopic level to the micro fluidic CNT-array cartridge. Nanosensors employed by CerMed have been shown in other applications to provide superior performance compared to laboratory-based instrumentation. In the context of CerMark, these nanosensors will aid in the rapid, quantitative immunodetection of proteins critical in ascertaining cervical cancer risk particularly in areas of the world where the needed is greatest but which lack normal screening practices.
CerMark Cervical Cancer Screening System advantages over the standard cervical cancer screening (Pap) process:
- Detects both HPV presence AND HPV induced cellular changes.
- Detects presence of proteins expressed when cells show rapid proliferations as found in cervical cancer cells.
- Detects the presence of proteins indicative of a block in apoptosis, a normal processes for removing altered or damaged cells.
- Improved sensitivity and specificity.
- Immediate results for diagnosis and treatment in one visit.
- Easy to use instrument system can be used by non-technical personnel.
- Reduces patient anxiety.
- Lower cost makes it affordable to women worldwide.
CerMark™ is a trademark of CerMed Corporation.