CERVICAL CANCER MARKET

Cervical cancer is one of the most common cancers among women in the world. If detected early, cervical cancer precursors can be treated effectively. The Pap test (also called Pap smear or cervical cytology screening) is the primary screening test for the detection of cervical cancer precursors. This test can identify morphologically abnormal cells of the cervix (cervical cells that have abnormal shape, size, or characteristics). Abnormal cells may be dysplastic precancerous lesions or cancer cells. A lesion is called precancerous when there is a high, yet not mandatory risk of progression to cancer if left untreated.

Primary Cervical Cancer Screening

Each year 110 million Pap tests are performed worldwide, with approximately half being performed in the United States. Widespread adoption of the Pap test by the medical community in the US has dramatically reduced the incidence of cervical cancer by 75% over the last 50 years. Despite its success as a public health measure, a Pap testing is relatively insensitive, poorly reproducible and frequently yields equivocal results. Inadequate sampling, the scarcity of aberrant cells in some samples and the subjectivity of morphologic interpretation are recognized limitations of cytology. In addition, equivocal and mild cytological abnormalities are extremely common in young women, but most of these lesions regress spontaneously. These difficulties cause physicians to struggle with a range of patient management and care decisions. Pap tests are repeated frequently in order to overcome the test's high rate of false negative results (low sensitivity). Improved versions of the Pap test have been developed in an effort to reduce the rate of false negatives by better distributing the cervical cells for analysis, but these liquid-based cytology (LBC) tests perform only slightly better, despite their widespread adoption. Therefore, a market opportunity exists to develop and provide diagnostic tests that detect genetic markers associated with cancer development.

Secondary Cervical Cancer Testing

When abnormal or aberrant results are returned from diagnostic tests, the patients' samples are reflexively tested by other methods to confirm the results and provide more detailed medical information. Approximately 7% of Pap tests are diagnosed with abnormal cells (atypical squamous cells of undetermined significance or ASCUS) and require secondary, or 'reflex', testing. The diagnosis of ASCUS is poorly reproducible. , In addition, about 10% of patients diagnosed with ASCUS have undetected cancer.

For cervical cancer the reflex test is determining whether the sample has been infected with specific strains of human papillomavirus (HPV) that have been linked to the development of cancer. Epidemiological studies have implicated the infection of cervical cells by specific strains of HPV to be necessary for the development of cervical cancer. However, the research has also demonstrated that an HPV infection is not sufficient to develop cancer. This lack of sufficiency means that other factors and/or changes in the cervical cells must occur for cancer to develop. This provides the physicians with a difficult medical scenario. Patients who have abnormal Pap tests and are negative by HPV testing will likely not develop cervical cancer, but are still monitored more closely. Patients who have abnormal Pap tests and are positive by HPV testing could develop cervical cancer, but many do not. These patients are referred for colposcopy, a technique that enables physicians to microscopically evaluate the surface of the cervix for abnormalities. If any lesions are found a biopsy is taken and analyzed. Patients with abnormal cervical lesions are then surgically treated using a variety of methods depending on the severity of their condition.

Approximately 7% of women have abnormal or aberrant Pap test results each year. Of these 3.5 Million women, 60% are tested for HPV infection. Because HPV infects about 90% of the population, the vast majority of these tests return positive results. This leads to very high, greater then 55%, referral rates to colposcopy. However, only about 20% of referred patients have cervical lesions identified by colposcopy. Of the approximately 1.5 Million women referred for colposcopy about 300,000 of them have identifiable cervical lesions and require further treatment. The great disparity between the referral rate and the disease rate is primarily due to the lack of relevant diagnostic tests to triage patients. NeoDiagnostix anticipates filling this market opportunity by offering tests that analyze the cervical cell's genetic structure.