PRODUCTS
The CerMap Cervical Specimen Collection and Mapping System provides a unique simplified, low-cost alternative to the Pap test collection with enhanced sample quality leading to improved diagnostic value. CerMap not only can be marketed as a stand alone product that improves the sample collected for Pap smears, but also is the front-end specimen collection device for CerMed’s Cervical Cancer Screening Test System. CerMap is a single use, disposable device intended for a 360-degree collection of material from the entire cervix (endocervix, transitional zone and ectocervix). This includes a tip with an inflation device to allow collection and then cell transfer to a slide, while preserving the spatial relationship of the cervical sample collected. This allows any areas of concern (pre-cancer or cancer) to be easily located on the cervix by the physician. In addition to providing a more complete sample and mapping, the sample collected is: 1) collected with less mucous and blood providing a cleaner sample to the lab, 2) a more concentrated sample that allows the lab to increase the number of slides reviewed by expensive technicians (more cost effective), and 3) has been shown to be a more comfortable sample collection. Each of these features provides improved diagnostic quality and value.
Cervical Cancer Screening Test System**
MEMS Cartridge
The cartridge detection system is based on identifying multiple markers within whole cells collected from the cervix. The sample is initially collect with CerMap, and after stamping a slide, the remaining cells will be introduced into a liquid preservative and then into the cartridge and flowed through the MEMS chip. Multiple markers will be employed to detect both viral and mammalian proteins reflective of cervical cancer originating from HPV infection. Determining the presence of multiple markers simultaneousy, with the potential of employing disease algorithms will increase the clinical relevance of the test. Thus, false positives are reduced and the predictive value of the test increased.
The instrument will be small, portable and battery operated to support field use. The instrument will be a simple test processor/ reader for assessing the signal provided by each biomarker. The test system is simply designed so that non-technical personnel will be able to use the system and obtain accurate results. The instrument will read each cell looking for the various targeted biomolecules, which will fluoresce at specific and distinct wavelengths if the targeted biomolecules are present. The instrument will analyze the signal and determine via proprietary algorithms which, if any, of the various biomolecules are present. The various combinations of positive results will be interpreted for the user into simple to understand results on an optional printout and on the instrument screen. It is anticipated that the entire test process will take 10 – 15 minutes.
CerCap™ HIV**
Cervical type caps
The CerCap HIV is a disposable, woman-controlled, cervical cap embedded with an anti-HIV to provide contraception and help prevent infection from HIV. A cervical cap is a latex or silicon thimble-shaped device that is inserted in the vagina and fits snugly over the cervix. Suction keeps the cap in place. A cervical cap provides a barrier to block sperm from entering the uterus and prevents fertilization; it also provides protection from many sexually transmitted diseases (STDs). Because it is made of silicon, CerCap HIV adheres to the cervix and offers a better fit with more comfort, cleanliness and convenience than the latex caps. Its thinness and flexibility is considerate of a couple’s intimate moments; when properly in place, it is not felt by the woman or the man during sexual relations. The silicon biomaterial used is nonallergenic and biocompatible. It is made of the same material as heart valves and coat pacemakers. Because it can be left in place from 72 hours up to 21 days, it offers women the prospect of real spontaneity in sexual relations.
PRODUCT NOTES:
* - Not available in the U.S.
** - Under development