Product Development
CERVICAL DIAGNOSTICS
Grant is developing blood based screening tests to screen woman for cervical cancer and pre-cancerous conditions. Our tests detect the presence of certain antibodies that appear only when cervical cancer or certain pre-cancerous conditions are present in the body evidenced by certain proteins which facilitate cervical cancer development.
CERVICAL CANCER
Invasive cervical cancer affects over 500,000 women worldwide annually, and approximately 300,000 women die each year from this disease. Cervical cancer is the second highest cause of cancer death among women. In the United States, Western Europe and other countries where there is widespread screening and a well developed testing or diagnostic infrastructure, invasive cervical cancer is less prevalent. In China, India and many other countries, there is a much higher incidence of invasive cervical cancer because of the lack of testing or limited diagnostic testing infrastructure.
CURRENT TESTING
Pap tests have been the most prevalent cervical cancer screening method for more than 50 years. Recent improvements include the liquid based pap tests. Today, approximately 60 million pap tests are performed annually in the United States, and an additional 60 million pap tests are performed annually in the rest of the world, mainly in Canada, Western Europe and Japan. It is estimated that outside of the United States, Canada, Western Europe and Japan, approximately 1.7 billion women do not undergo regular cervical cancer testing. In many cases, this scarcity of testing is the result of a lack of economic resources, as well as social, cultural and/or religious factors which may contribute to women not undergoing cervical cancer screening. Under these circumstances, in some nations, the mortality rate of cervical cancer approaches 100%. Grant will seek to market its cervical cancer test in major countries such as China, India, Mexico and Canada as well as in the United States. In the United States alone, approximately $4 Billion is spent by women on pap tests.
HPV CAUSE
Virtually all-cervical cancer is caused by human papillomavirus or HPV. However, of the more than 100 specific types of HPV, the scientific community believes only 7 to 15 are positively correlated with most cervical cancers. In recent years, gene- or DNA-based HPV tests have been introduced as an adjunct to the pap test. These test detect the presence of the virus, HPV presence alone does not mean disease.
GRANT LIFE SCIENCE’S TEST
Our tests are performed by analyzing a small amount of the patient’s blood. In one version of our test (the AbReact) the blood sample is analyzed in a clinical setting using standard laboratory equipment (ELISA) and analytic software, which generally can produce completed results in about 2 hours. Our rapid test (QuickStrip) provides easy-to-read results in approximately 15 minutes and is designed to be administered by a health professional in a doctor’s office, hospital, and clinic or even at home. We believe that a sensitive, reliable, non-invasive point-of-care test for cervical cancer will enhance the prospects for wider use by women worldwide and result in better and earlier detection of cervical disease.
ADDITIONAL PRODUCTS AND TECHNOLOGY
Purchase of AccudX Corporation
Grant Life Sciences has shipped its first order of Malaria rapid diagnostic tests to India. This product, along with rapid tests for Dengue Fever, HIV-1 and HIV-2, among others, was licensed earlier this year from AccuDx Corp. AccuDx is a biotechnology company based in La Jolla, Calif., founded by Ravi Pottahil, Ph.D., one of the world’s leading authorities in the field of HIV/AIDS diagnostics and therapeutics. Grant Life Sciences owns the exclusive rights to AccuDx’s rapid tests.
While this initial order totaling $75,000 is admittedly small, nonetheless it is evidence that we are executing our strategy to revitalize AccuDx’s distributor networks in overseas markets. While we expect revenues to continue to increase, seasonal fluctuations due to the nature of specific diseases will affect monthly sales. For example, Malaria and Dengue Fever are highly seasonal diseases. However, to offset seasonal fluctuations, we plan on broadening our family of diagnostic tests utilized at both the point-of-care as well as in the laboratory setting.
The Company’s goal is to have a global distributorship network in place, along with the requisite manufacturing capacity, so that we can begin selling our core product, the immunological serum-based test for detecting Cervical Cancer and its precursors, as soon as it is ready for commercialization.
In-Licensing of Technology Sponsored by The United States Government Bio-Industry Initiative
Grant Life Sciences Inc. has signed a Memorandum of Understanding (MOU) with Dr. Peter Sveshnikov and Dr. Vsevolod Kiselev of the Russian Republic for the in-licensing of certain of their technologies that are highly complementary to Grant’s antibody-based test for detecting cervical cancer. The Sveshnikov/Kiselev technology comes to Grant from the U.S. State Department through its Bio-Industry Initiative (BII) program. The BII is designed to foster medical and other biological research and development in the former Soviet Union by converting former bio-warfare scientists to productive peacetime activities.
Sveshnikov/Kiselev have developed an Enzyme-Linked Immunosorbent Assay (ELISA) to detect specific cancer-causing proteins from the human papillomavirus (HPV) — the obligate cause of cervical cancer — in the cervical mucous and cells (which make up liquid-based pap samples). The test utilizes certain monoclonal antibodies against these cancer-causing HPV proteins for detection. Thus far, the test is designed to detect cancer-causing proteins from HPV types 16 and 18 which, collectively, are responsible for most cervical disease. This type-specific antigen test, once fully validated and expanded to include additional types of HPV associated with cervical dysplasia and cancer, would be a very synergistic and complementary test to existing Pap technology. It will provide for very low-cost HPV testing as currently performed in Western countries, without the need for additional cervical specimens beyond what is now taken. In addition, large capital outlays would not be required, since most laboratories can readily do ELISA testing.
Sveshnidov/Kiselev have already tested their technology with 1000 Russian samples to confirm the potential of this technology. Grant will be further validating with more specimens from Russia and via the many cervical specimens obtained in the United States under its Institutional Review Board (IRB) approval in controlled clinical settings.
Together, when validated, Grant will have two complementary cervical dysplasia or cancer diagnostic tests that will work on blood serum or cervical mucous and cells. A blood-based test is eminently suitable for the 1.7 billion women worldwide who currently are not tested by Pap smear cytology. This inadequacy results in over 300,000 deaths per year. Meanwhile, a test employing cervical mucous or cells is readily fitting for Western medical venues, and has the potential of reducing costs dramatically when compared against those for current HPV DNA-testing. Furthermore, it could significantly reduce expenditures for follow-up referral procedures that turn out to be overwhelmingly negative, with billions of dollars per year in unnecessary medical expenses saved as a consequence.
