TECHNOLOGY & PATENTS
CerMed’s three initial products are based on four core technologies, three of which are essential to the development of the proprietary platform test system which provides a highly sensitive, rapid, easy to use, point of care diagnostic tool. The first product will screen cervical cells for cancer using a combination of four biomarkers in conjunction with a MEMS chip on a flow cytometric cartridge.
CerMed has a strong technology and patent position through its own efforts as well as through in-licensed technology and OEM product development agreements. In total, CerMed products will be protected by at least 11 patents: 4 patents issued, 4 patents pending, and 3 under preparation. It is anticipated that additional patents will be applied for as the novel products are finalized and then expanded to include additional applications.
The CerMap Cervical Specimen Collection and Mapping System is proprietary and unique, providing for improved collection of cervical specimens and mapping of the same sample for easier more focused follow-up by the clinician, thereby eliminating unnecessary biopsies is areas not indicated. 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.
The CerMap system is protected under its own patent applications as a result of its own design, development and testing. In addition, although CerMed has a license agreement, that has yet to be acted upon by the parties, CerMed has not only filed its own patents, but has commenced manufacturing and testing of its own system outside the elements of the license agreement.
CerMed has additional patents in process to protect this unique cervical mapping and collection system and has additional patents under development.
CerCap™ HIV
None of the current contraceptive devices, with the exception of the condom, prevent sexually transmitted diseases (STDs), including HIV. Although most STDs are treatable, the viral diseases such as HPV, HIV and Herpes Simplex Virus are not. The incorporation of an anti-viral into barrier contraceptives under the control of the woman is of considerable interest and value. This would allow the woman to not only use a contraceptive device without the man’s knowledge, but to also ensure she is safer from HIV.
CerMed is working with the world’s leading experts in the development of drug elution barrier contraception. The CerCap HIV is a drug-eluting, cervical barrier cap that provide the dual benefits of contraception and prevention of HIV. An anti-HIV drug is released over time while the cervical cap is in place, reducing the risk of acquiring an HIV infection while in place. The CerCap is being tested to allow it to remain in place for up to 28 days.
CerMed has developed a patent under preparation for CerCap HIV. The patent covers improvement in cervical cap design that provides a replaceable and/or integrated polymer ring for elution of compounds to prevent pregnancy and/or microbicides to inhibit HIV infection. Future claims could include dispensing compounds for treatment of gonorrhea, Chlamydia, and other common vaginal infections.
Cervical Cancer Screening Test System
CerMed’s technology strategy requires the efficient design/development of a MEMS-based flow device to support a flow cytometric protocol for cervical cancer detection. Protocol and biomarker validation are critical since the developed protocol will serve as the basis of cervical cancer detection on the proposed MEMS device. Immunodetection of cellular proteins is commonly achieved with flow cytometry and in itself represents a low risk event. With the aid of strategic collaborators, CerMed is adapting its protocol for cervical screening from the macroscopic level to the micro fluidic level and early efforts will ensure specificity and sensitivity of the assay prior to reduction to the MEMS platform. Target biomarker specific clones chosen for inclusion in CerMed’s screen have been repeatedly shown in the literature to correlate very highly with the presence of cervical lesions resulting from HPV infection. It is CerMed’s intent to adapt the use of such markers to a point-of-care flow cytometric platform rather then employ them in labor intensive immunocytology practices. CerMed has data validating it approach with flow cytomertry and the selection of biomarkers for the detection of cervical cancer in a screening environment.
A brief outline of partnerships, their contributing roles, and IP is provided below:
Partnerships
a. Duke: Leader in women’s health care (oncology/gynecology) Proven antibody clones for cervical biomarker detection Strong clinical resources and research network Focus on protocol development and clinical validation
b. IMT: Extensive IP in MEMS product development Prior development success in MEMS flow devices Leading MEMS manufacturer Innovative and talented team Development of MEMS cartridge for flow detection
CerMed has filed a provisional patent application to protect its intellectual property related to the cervical screening disposable and instrument under development: Cervical Cancer Screening by Molecular Detection of Human Papillomavirus-Induced Neoplasma USPTO 61/260,829
Intellectual property held by Innovative Micro Technology, Santa Barbara, CA USA and under license to CerMed for use in the products developed include:
Method and Apparatus for Sorting Biological Cells with a MEMS Device; US Patent #6,838,056 & US Patent #7,264,972
Method and Apparatus for Sorting Particles with a MEMS Device; US Patent #7,220,594
MEMS Actuator and Method of Manufacture for MEMS Particle Sorting Device US Patent #7,229,838
Intellectual property held by Duke University for their antibodies and under exclusive licenses to CerMed for this product are in progress.