Cleveland Diagnostics, Inc Cleveland Diagnostics, Inc. (CD’x) has an innovative and proven diagnostic technology platform intended for the diagnosis of cancer in the early stages using blood tests. CD’x developing technology that focuses on protein biomarker structural changes that correlate with the presence of a disease. The company’s development portfolio of non-invasive cancer diagnostic tests includes blood-based tests to screen for prostate, breast and ovarian cancer. Tests are designed to enable early detection of cancer cells, allowing for early treatment and increased survival rates.
CD’x strategy is to develop diagnostic products and cooperate with strategic players to market, commercialize and distribute the company’s products. The prostate cancer test is the company’s first test. This test is ready for commercialization. The company is currently dealings with several strategic entities to commercialize the test.
CDX Investment Technology
Your DNA is essentially a set of instructions. It is made up of genes, which are the molecular unit of heredity. Therefore, genes decide your biological traits, such as eye color. Genetic switches determine which genes should be expressed. For example, a heart cell will express very different genes than a brain cell. When “turned on”, these genes are transcribed into single-stranded RNA. RNA is then translated into proteins, which play a variety of roles in the body, such as catalyzing reactions, replicating DNA, transporting molecules, and much more. Essentially – we all are just manifestation of proteins working together. Under certain physiological conditions such as stress or disease, a specific protein may be overexpressed or underexpressed. This is the current basis of a biomarker, which is a measurable protein whose altered expression indicates that an individual has a disease. However, in addition to changing the level of protein, diseases also modify the structure of proteins.
Prostate cancer is the biggest cause of mortality among US men after lung cancer. Each year, 1.7 million biopsies are carried out in the US, of which about 75% of biopsy tests are negative or low risk of cancer requiring intervention treatment. All this causes a burden to patients and unnecessary costs for the health system.
IsoPSA™ clinical status
IsoPSA™ is a structure-based (rather than concentration-based) reagent that agnostically interrogates the entire spectrum of structural changes of complex PSA. It does so by partitioning isoforms of prostate-specific antigen (PSA) with an aqueous two-phase solution.
The IsoPSA™ assay Multi-center clinical trial in the US, led by Dr. Eric Klein, head of the Glickman Urological & Kidney Institute at the Cleveland Clinic , medical center, who is considered a leading global expert in the field.
The trial itself and the extension trial, which included about 500 males, the IsoPSA test of CDx met both study objectives: The test was able to reduce by approximately 45% the rates of unnecessary biopsies when diagnosing cancer patients at all grades of the disease.
The trial proved that the IsoPSA test significantly better identifies patients with the potential for aggressive cancer needing treatment.
The interim analysis of the study has been published in European Urology.
Prostate-specific antigen, the current gold standard in prostate cancer detection, is distinct from virtually all other cancer biomarkers because of its almost exclusive specificity to the prostate, allowing direct assessment of physiological conditions in the gland with a simple blood test. Unfortunately, PSA is tissue- but not cancer-specific, and overdiagnosis and overtreatment of PSA-detected, biologically insignificant cancers are widely recognized as key limitations in its clinical utility.