Cleveland Diagnostics, Inc. (Cleveland DX) is 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.

CDX has signed a commercialization agreement with US company Genomic Health (Nasdaq: GHDX) worth about $2 million in convertible bonds that will be paid immediately and an additional amount of $3 million in convertible bonds as well as a further payment of $5 million on the successful completion of an ongoing multi-focus trial due to be completed during the first half of 2018. In addition, royalties will be paid as well as further payments that will be made over the coming years according to targets of insurance indemnity payments received in the US, biennial sales targets, and additional future licensing rights. Signing the agreement grants Genomic Health an exclusive license in the US and most countries worldwide to develop and commercialize IsoPSA™, the innovative test developed by CDX for the early diagnosis of prostate cancer, which is not influenced by external factors that generally do influence tests to diagnose cancer.

Genomic Health is the world’s leading provider of genetic molecular diagnostics for optimizing cancer treatment. The company has over 200 sales representatives in more than 90 countries worldwide, and the test that it provides has to date allowed hundreds of thousands of patients to receive personally adapted treatment for prostate cancer, breast cancer and bowel cancer.

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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™ 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 is currently involved in a multi-center prospective pilot study and not available in the United States. The interim analysis of the study has been published in European Urology

Why IsoPSA™
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.

CDx In The News

May 10, 2016 - AUA 2016 - IsoPSA: Initial Clinical Performance Evaluation of a Novel Structure-Based Biomarker For Prostate Cancer in a Multicenter Prospective Trial for Gleason = 7