The new company is scooping up cancer diagnostic technology developed by Analiza Dx and combining it with technology from the Clinic to create new blood-based tests for cancer.
The technology is unique in that it measures changes to the structure of certain proteins in the blood that result from the presence of disease, explained Arnon Chait, who led Analiza Dx and will become CEO of Cleveland Diagnostics. “Instead of offering very expensive tools, like genetic analysis for example, we use a more common and low-cost approach (ELISA) to look at things that matter.”
By “things that matter,” he means actual changes to the structure of proteins, rather than the presence or concentration of those proteins in the blood. Because cancer is by nature a mutative disease, this approach makes more sense, he said.
Furthest along in the company’s pipeline is a prostate cancer test that Chait envisions could eventually replace the standard PSA test, which measures the concentration of prostate-specific antigen in the blood. That test raises a number of issues, among them that several other factors besides cancer can contribute to high PSA levels. That means the next step in the diagnosis process, a biopsy, is often used as more of a screening tool rather than a confirmatory test, Chait said.
“We took the same molecule, PSA, but instead of looking at concentration, we are saying, ‘did it come from a cancer cell or a healthy cell?’” he explained.
That means the technique could also be used to look at other proteins, too. For example, the company is also in early development a test built on the same platform that could detect structural protein changes associated with breast cancer and ovarian cancer, the latter of which has no effective early diagnostic tool. Chait said the vision is for women who know they’re at high-risk for breast or ovarian cancer to be able to get screened yearly, to have a better guide for whether to move forward with preventative interventions.
According to Chait, the company has already done some early studies with the Clinic on the prostate test. Initially, it would be commercialized as a lab-based test, meaning it would need CLIA certification rather than the more rigorous FDA approval. Down the road, though, he said it would probably be turned into a kit to enable widespread distribution and use.
The cancer diagnostics market is growing rapidly, which means Cleveland Diagnostics will inevitably face competitors. But Chait seemed confident that the company is armed with a cheap and effective diagnostic tool that could ultimately cut costs from the system by reducing unnecessary biopsies and preventive surgeries and prompting earlier diagnosis.