Message #15 From:
Stock News Bot Date: October 11, 2005 04:52:00 AM
MCDG News Molecular Diagnostics Congratulates Merck Scientists on the Advancement of Their New HPV Vaccine
CHICAGO--(BUSINESS WIRE)--Oct. 11, 2005--The head of Molecular Diagnostics, Inc. (OTCBB: MCDG.OB) Medical Advisory committee, Dr. George Gorodeski, M.D., Ph.D., Professor, Department of Reproductive Biology, Case Western Reserve University commented: "The news released on Thursday October 6th, by Merck Co. Inc. (NYSE: MRK) of a new anti HPV vaccine that could potentially prevent uterine cervical HPV infections in women is truly exciting. As a Physician dedicated to women's reproductive health issues, this is an important incremental step forward in the efforts to provide new solutions to this very treatable disease.
"However, before drawing any practical conclusions we need to wait for peer-reviewed and routine clinical data. It remains to be seen when the product is available for women in the US, whether the preliminary data reported in the Press Release translates into routine clinical practice and results. The premise that the vaccine may be effective only if administered to HPV non-infected women could be a drawback because sexually active women acquire HPV early on in life, and it is not clear to what degree adults (both women and men) would be willing to engage in the vaccination program. Ultimately, the vaccine's utilization and effectiveness may be shaped primarily by economic and societal forces.
"However, the emergence of this new class of vaccines should help draw and focus attention on this very treatable cancer and killer of women. Screening for cervical cancer is likely to continue even if vaccinations are introduced into clinical practice because the relatively simple and cost-effective testing (e.g. pap smears or its replacement procedure) will still be required by the vast majority of women. On a world-wide basis, only a very small percentage of young women may be able or willing to take this vaccine. In view of emerging new medical technologies and preventive modalities, one of the important challenges our profession faces is the need to improve and upgrade the current methods for screening women at risk of developing cervical cancer, hopefully making the screening process faster, more accurate, and less expensive. This is especially true for the developing economies where women do not have access or the resources to pay for our levels of medical technology."
Molecular Diagnostics, committed to improving cervical cancer screening with its InPath System, is going to bring cervical cancer screening into the 21st. Century.
MDI's CEO Dr. David Weissberg stated: "We are very pleased to see this new vaccine announced, because it helps focus attention on the need for better solutions to this disease, the second leading killer of women world-wide. This vaccine will not supplant the necessity for a PAP test, but rather, we see it as a complement to the existing testing procedures and another step in the development of preventative healthcare solutions to address this disease.
"At Molecular, we are bringing together a set of unique technologies to produce a breakthrough in cervical cancer screening with our InPath System. It is designed to improve, strengthen and streamline the traditional PAP cancer screening capabilities in a fraction of the time and cost. Each of the three components of the InPath System dramatically improves upon its current PAP test counterpart.
"First, the FDA approved e2 Collector is a substantial improvement on the spatula/brush cell collection methodology. The e2 Collector mirrors the upper cervical surface including the upper canal, thereby providing a thorough cell sampling on the Collector's surface in one brief exam. The Collector has proven to be much quicker, more comfortable for the woman, and delivers a more thorough cell collection which produces greater sensitivity and specificity for the cervical screen process.
"Second, the CVX cocktail is a complex set of bio-markers that tests for the presence of proteins expressed when cells reach the cancerous stage. These cells through a technology called proteomics are turned fluorescent, which is a very direct and unambiguous method of identifying these cells. In our Phase I testing, the cocktail demonstrated significant improvement over the parallel PAP test. It produced much greater sensitivity and specificity of damaged cells with a minimum of false positives.
"The final component to the system is the AIPS automated microscopy platform. This platform automatically scans the treated slides looking for the presence of fluorescence. If the software finds these types of cells, it guides the physician or specialist to examine the cells in question and make the diagnosis.
"MDI has brought a number of new medical technologies to bear in the development of this product. The combination of a new cell collector, a cutting edge bio-tech cocktail for highly accurate identification of cancerous cells, and our image identification software driven automated screening platform consistently identifies the marked cells for the physician to diagnose.
"The InPath System offers a true breakthrough in cervical cancer screening by improving the accuracy and consistency of the screening while dramatically reducing the time and the cost of the test. Maybe most importantly, this System will allow for the test to be given by the Doctor at the point of service (the Doctor's office, Clinic, Hospital or Lab) with the test results available right there in minutes, all for a few dollars cost. I believe the capabilities our System offers will be especially attractive to the HMO's and major Hospitals that process their own tests, because of the improved accuracy, consistency and cost structure of the InPath Test, that's a total of 180 million cervical cancer screening tests that will continue to be done annually in the US, Europe and Japan. Given the litigious society we as physicians find ourselves in, it is important for us to be able to screen our patients and get them the appropriate diagnosis before they are lost to follow up and later return as a liability.
"The lack of such a specific type of cervical cancer screening capability leads to 300,000 women world wide dying needlessly every year. The female population group that needs to be tested is approximately 1.2-1.4 billion women. This is the technology which will make cervical cancer screening available to the vast majority of women world-wide that have never had such a test."
About Molecular Diagnostics, Inc.
Molecular Diagnostics develops cost-effective cancer screening systems, which can be utilized in a laboratory or at the point-of-care, to assist in the early detection of cervical, gastrointestinal, and other cancers. The InPath(TM) System is being developed to provide medical practitioners with a highly accurate, low-cost, cervical cancer screening system that can be integrated into existing medical models or at the point-of-care.
Certain statements in this release are forward-looking. These statements are based on Molecular Diagnostics' current expectations and involve many risks and uncertainties, such as the company's inability to obtain sufficient financing, the possibility that clinical trials will not substantiate Molecular Diagnostics' expectations with respect to the InPath(TM) System, and other factors set forth in reports and documents filed by Molecular Diagnostics with the Securities and Exchange Commission. Actual results may differ materially from Molecular Diagnostic's current expectations depending upon a number of factors affecting the Company's business. These factors include, among others, risks and uncertainties detailed in the Company's periodic public filings with the Securities and Exchange Commission, including but not limited to the Company's Annual Report on Form 10-KSB for the year ended December 31, 2004 and its Quarterly Reports on Form 10-QSB for the quarters ended March 31, 2005 and June 30, 2005. Except as expressly required by law, Molecular Diagnostics undertakes no obligation to publicly update or revise any forward-looking statements contained herein.
