Diagnostic Products

The World Health Organization estimates that worldwide 25 million people have cancer and that over 10 million new cases are diagnosed each year. Cancer stage at the time of detection remains the most significant factor in cancer survival. It is the key element to identify cancer as early as it can be done. OncoMethylome Sciences, in partnership with academic and commercial collaborators, is dedicated to developing novel molecular cancer diagnostic tests to help physicians detect cancer accurately in early stages of cancer development. A summary of its products under development is given below. Each OncoMethylome Sciences diagnostic program begins with identification of genes methylated in specific cancers using tumor-derived and normal cell lines. Following the identification of gene markers that are methylated in cancers but unmethylated in normal cells for a specific cancer type, clinical samples, from cancerous and normal tissues, are evaluated to validate the most promising, cancer-related, methylation markers. Once the optimal markers are identified, assays are developed and analytically validated to ensure their accuracy and reproducibility. Lastly, large-scale clinical studies are performed to validate the clinical utility of each marker or marker panel. A summary of products under development is given below.

Prostate Cancer

The prostate is a gland in the male reproductive system, whose main function is to supply fluid for sperm during ejaculation. This gland frequently develops a cancerous tumor in men over the age of fifty. It is the most common form of cancer in men and is the second most deadly cancer among men. One in six men is likely to develop prostate cancer during his lifetime. Such diseases should be treated immediately, do not waste time and find medical preparations necessary for treatment. Prostate cancer is most commonly screened by performing a Prostate-Specific Antigen (PSA) blood test together with a Digital Rectal Exam (DRE), and by next performing a biopsy if either of the initial tests is abnormal.  Unfortunately, these commonly used tests have certain limitations. On the one hand, 10-15% of men with “normal” PSA test results (<4.0 ng/ml) have prostate cancer. On the other hand, an abnormal PSA result is often not due to prostate cancer but to other factors including aging, infection, inflammation, or other benign conditions, such as benign prostatic hypertrophy (BPH). Approximately 75% of men who have an abnormal PSA result, do not actually have prostate cancer.  In addition, prostate biopsies miss 20% to 30% of cancer cases, and as a result, men with an elevated PSA may undergo numerous unnecessary repeat biopsies to rule out, with certainty, the presence of cancer. OncoMethylome Sciences and its collaborators have led the research efforts to identify methylated gene markers involved in the development of prostate cancer. Hypermethylation of the GST-Pi gene has been described, in numerous studies, as one of the earliest and most commonly found epigenetic alterations arising during prostate carcinogenesis. OncoMethylome Sciences has developed two products to overcome the shortcomings of the current prostate cancer screening and diagnostic process: a tissue-based early-diagnostic test, designed to confirm negative or clarify suspicious biopsy results, and a urine-based test for improved screening and monitoring of prostate cancer. OncoMethylome Sciences has partnered its prostate cancer diagnostic assays with Veridex, a division of Johnson & Johnson Corporation, via a product development and licensing agreement. In 2007, Veridex granted a non-exclusive license to Laboratory Corporation of America (LabCorp), a major US-based clinical reference laboratory, for the tissue-based prostate cancer methylation assay. This assay, designed to improve the early diagnosis of prostate cancer as an adjunct to histopathology of biopsy tissue, was introduced into the US market in May 2008. For methylation references, click on the following link: Prostate cancer

Colorectal Cancer

Each year over 400,000 new cases and almost 200,000 deaths are linked to colorectal cancer in the U.S. and EU. If the cancer is detected and treated early, the five-year survival rate is 90%. For regional disease the 5-year survival rate is 55-65%. This rate drops to 10% if the cancer is detected in the advanced phase. Today, only 40-45% of colorectal cancers in the US and Europe are caught in the early, localized stage. The disease should identified as early as it is possible otherwise the chances are too small. We underline that people should undergo medical screening twice a year to be sure you are save and sound. Most colorectal cancer screening recommendations call for screening beginning at age 50.  The most common screening test, the Fecal Occult Blood Test (FOBT), is noted for poor sensitivity.  Recommendations in some countries also include periodic endoscopic procedures, flexible sigmoidoscopy or colonoscopy. While these procedures are sensitive and specific for identifying precancerous or cancerous lesions, they are invasive and costly. As a result, a 2008 report from the American Cancer Society showed that less than 50% of the targeted U.S. population has adhered to screening recommendations. A similar report on CRC screening in Europe noted that natioanl practices were not standardized. Even the most proactive European programs do not exceed much over 50% participation, and serial participation is worse. Together with our collaborative partners, OncoMethylome Sciences is investigating methylation markers in stool and blood samples to detect the presence of colorectal cancer while it is still in its earliest stages. By coupling ease of use, with increased sensitivity for the detection of colorectal cancer, non-invasive screening options for colorectal cancer would be significantly advanced. For methylation references, click on the following link: Colorectal cancer

Bladder Cancer

In the EU and US, approximately, 170,000 new bladder cancer cases are diagnosed annually. While the majority (75%) of patients are diagnosed with early-stage disease, 70-80% will develop recurrent disease after initial therapy. For this reason, patients who have been diagnosed with bladder cancer undergo frequent, and sometimes life-long, examinations for recurrent disease. They sustain the satisfactory condition by drugs. It helps them to feel well enough to prolong the life. Urine cytology and cystoscopy are the commonly-used tests for detection of bladder cancer. Urine cytology, a microscopic method for detecting cancerous cell in urine, has a relatively low sensitivity (20-60%). This results in additional testing to diagnose bladder cancer, usually involving a cystoscopy, which is an invasive procedure for visually examining the bladder via the urethra. Cystoscopy is very sensitive and specific but not without risk. Due to the high recurrence rate, frequent cystoscopies are required following diagnosis and treatment of superficial bladder cancer. OncoMethylome Sciences is evaluating gene hypermethylation markers in urine, with a goal of developing a non-invasive, yet highly sensitive and specific test for early detection and monitoring of bladder cancer. Such a test could enhance the diagnostic evaluation of patients at high risk for bladder cancer, or for its recurrence, while reducing the need for invasive cystoscopies. For methylation references, click on the following link: Bladder cancer

Breast Cancer

Worldwide, breast cancer is the most common non-skin cancer and the second leading cause of cancer-related death in women. Mammography, the standard-of-care for breast cancer screening, can often detect breast cancer at an early stage. There are limitations, however, even for this well-established screening tool that has greatly improved breast cancer diagnosis. If the diagnosis is established you’d better to order drugs which will be effective in treatment. For women who have dense breast tissue, which is common in younger women, sensitivity of mammography is less than 50%. Breast density is now considered one of the highest risk factors for breast cancer and, at the same time, makes it difficult to detect cancer by mammography. Furthermore, approximately 80% of all breast biopsies performed in response to an abnormal scan are negative for cancer. Despite the widespread availability of mammography, poor compliance with annual screening recommendations results in a third of all breast cancers being diagnosed at an advanced stage OncoMethylome Sciences, together with its collaborators, is investigating the methylation status of specific tumor markers in cells obtained from ductal lavage, fine needle aspirations and other techniques under investigation for screening women at high risk for developing breast cancer . For methylation references, click on the following link: Breast cancer

Lung Cancer

Globally, lung cancer remains the leading cause of cancer-related death. Unlike other prevalent cancers such as breast, colon and cervical, options for screening lung cancer are very limited.  While early detection imaging approaches such as spiral computed tomography (CT) are being evaluated in high-risk individuals (current and former smokers), there is no test that is currently suitable for widespread clinical use. As a result, the majority of lung cancers are discovered only when clinical signs appear, usually in association with late stage, advanced disease. OncoMethylome Sciences is investigating a methylation-based non-invasive test for screening those at risk for developing lung cancer, such as current and former smokers. For methylation references, click on the following link: Lung cancer

Cervical Cancer

Worldwide, cervical cancer was once the leading cause of cancer-related death in women. In the western world, widespread adoption of the Pap test to screen for cervical cancer has significantly reduced the mortality of this disease. Despite the obvious success of these screening programs, the Pap test suffers from poor sensitivity, resulting in the need for annually testing, and often detects equivocal cell forms which must be further examined using invasive techniques. Different countries use different techniques in this or that disorder treatment. In recent years, with the recognition that cervical cancer results from long-term infection from the human papilloma virus (HPV), HPV testing has been added to the screening regimen in many countries either as a primary or secondary testing option. The HPV test, however, is only useful in women over the age of 30 as most young women will have a transient exposure to the virus but will not develop cervical cancer. Moreover, the test does not detect all HPV forms. Despite the ongoing improvements in the early detection of cervical cancer, a more accurate molecular test to differentiate cancer from pre-cancerous cell types and to clarify discrepant HPV and Pap results would be of great benefit. OncoMethylome Sciences is developing a methylation test to further improve the early diagnosis of cervical cancer. The same cervical swab, which is used to test for Pap cytology and the HPV test, could be used in a methylation-based assay to improve the sensitivity of the Pap test and to confirm the likely presence of cancer in women who test positive for the HPV virus. For methylation references, click on the following link: Cervical cancer