CANCER OVERVIEW

The Diagnosis of Cancer - Current Practice

Cancer is the number one killer of people in the prime of life. The medical community is desperately searching for better ways to detect, diagnose, and treat this disease.

Treatment of cancer with curative intent requires the early detection of pre-malignant and malignant lesions. When diagnosis is delayed until the appearance of overt clinical symptoms, such as weight loss, pain, or bleeding, the prognosis is significantly worse. Therefore, screening programs for early detection of cancer and pre-malignant disease are highly desirable. Specific examples of routine screening tests include Pap test screening for cervical cancer, PSA testing for prostate cancer, and mammography for breast cancer.

The diagnosis of potential tumor samples accrued by such screening methods still rely almost exclusively on a morphological assessment of cells - that is, by looking at the shape of cells and making a subjective prediction as to malignancy. Morphological assessment of patient samples has three critical limitations:

1. Prevalence of False Negative Test Results.

The earlier the lesions (both cancer and pre-malignant lesions) are detected, the more difficult it is to arrive at a definitive diagnosis because the crude morphological changes that define cancer cells are not yet present. Therefore, many dysplastic lesions and early cancers are not detected. This low sensitivity is the reason that Pap smears must be repeated at regular intervals.

2. Lack of Predictive Information.

Morphological assessment is limited to the status of the sample at the time of analysis and cannot predict risk of progression of individual lesions. The potential for the future development of the disease cannot be determined. This limitation can lead to aggressive surgical action at times when precancerous lesions are identified, whether or not the lesions would have become cancerous. For example, a person might undergo the surgical removal of part of the lining of the uterus (conization) because of ambiguous or incorrect Pap testing for cervical cancer.

3. Potential for False Positive Test Results.

Due to the inaccuracy of the morphological test, patients can falsely receive positive diagnostic test results. These patients will receive unnecessary follow-up diagnostic procedures, and may undergo pointless and damaging treatment.

There is a pressing market opportunity to develop molecular markers and tests that can (i) definitively diagnosis cancer; and (ii) that provide information regarding the progressive potential of early lesions. Peter Baldwin and his colleagues from the Hutchinson/MRC Cancer Center confirmed this need in a recent review article by saying, "A pressing demand exists for new approaches that could reduce false-negative and false-positive test results". The tests being developed by NeoDiagnostix should provide precisely this type of more definitive diagnostic and prognostic information.

NeoDiagnostix was founded to develop and provide of novel cancer diagnostic testing services using genetic technologies. The Company possesses highly specialized experience and skills in the area of Fluorescent In Situ Hybridization (FISH) techniques and is developing novel genetic FISH tests for the diagnosis, prognosis and treatment of cancer. By detecting genetic changes in the cells, NeoDiagnostix's tests can identify cancerous cells earlier than traditional testing methods. Earlier detection enables better treatment of the disease and increases the survival rate.