New prostate cancer test strives to slash biopsies

Prostate cancer is the second most common cancer in American men after skin cancer, with almost 190,000 new cases in the US expected for 2016 and about 26,000 deaths, according to the American Cancer Society. It is also the second leading cause of cancer death in American men, behind only lung cancer.

Prostate cancer can often be detected before symptoms arise by testing the amount of prostate-specific antigen (PSA) — a substance made by cells in the prostate gland — in the blood. A high level of PSA could be indicative of cancer and if a blood test finds this, the patient will most often be sent for a biopsy.

But here lies the problem. Because PSA is secreted both by normal cells and cancer cells, its levels could be high for other reasons and not necessarily cancer: age, an inflammation of the prostate gland, or even a bicycle ride. But most often when doctors receive a high reading, they send their patients to do a biopsy, just to be on the safe side.

“There are roughly 1.5 million primary biopsies done in the US a year,” says Israel-born Arnon Chait, the CEO of Cleveland Diagnostics, based in Cleveland, Ohio. “On average 70 percent come back negative.”

That is good news for the patient, but at a cost of about $4,000 per biopsy, health providers are not happy.

Thus Cleveland Diagnostics (CDX), founded by Chait and his partner Boris Zaslavsky in 2013, is developing a technology and test kit that can identify the PSA that specifically comes from cancer cells.

“We don’t look at the level of PSA in the blood – which is not specific to cancer,” Chait said. “Our test asks: where did this PSA come from, normal cells or cancer cells? This will help health providers save billions of dollars and patients won’t have to undergo unnecessary procedures.”

Potentially, said Chait, the new IsoPSA test, expected to enter the market in the last quarter of the year, could replace the current PSA test in the screening process in health centers.

This same technology could also be used in other applications, to detect breast cancer and ovarian cancer, Chait said, as well as for early diagnosis of Alzheimer’s disease.

“It is the same technology but looking at different proteins with different custom chemistry in the test kit,” he said. “And all of our tests are intimately connected to the underlying disease biology by detecting changes in the structure and state of the biomarker protein.”

Cleveland Clinic, in Cleveland, Ohio, a nonprofit academic medical center and one of the largest hospital systems in the US, is the company’s largest shareholder and clinical collaborator. Merchavia Holdings and Investments Ltd., whose shares are traded on the Tel Aviv Stock Exchange, is also an investor in CDX.

Chait was the founder of an interdisciplinary lab at NASA and has held several academic positions at universities, including Tufts and Case Western Reserve University.