A new type of prostate cancer screening test from AnalizaDx showed promise and a higher sensitivity than the leading method of detecting the disease, according to new research.
AnalizaDx’s prostate cancer test could represent “a major advance” in diagnosing the disease according to the lead author of the new study, Dr. Mark Stovsky, a urologist with University Hospitals (UH) Case Medical Center in Cleveland, according to a statement from UH.
The key difference in AnalizaDx’s technology is that it measures changes to the structures of certain proteins found in the blood, called biomarkers. That means the company’s technology has the potential to be far more accurate than other tests that measure only protein amounts, CEO Arnon Chait told MedCity News earlier this year.
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Contrast AnalizaDx’s test with the controversial prostate-specific antigen (PSA) test, which is widely used to screen men for the cancer. While it’s normal for men’s blood to contain low levels of PSA, a high level can indicate the presence of prostate cancer. And that’s where the trouble with the PSA begins — its high rate of false positives.
Only 25 percent to 35 percent of men who have a biopsy due to an elevated PSA level actually have prostate cancer, according to the National Cancer Institute (NCI). False positives can create anxiety for patients and lead to additional medical procedures that can be expensive and risky, the NCI said.
The recent study followed 222 men and found the urine-based AnalizaDx test had 100 percent sensitivity (no false negative results), and 80 percent specificity (low false positive results). The study data was collected at three clinical sites — UH Case Medical Center, the VA Boston Health System and Cleveland Clinic, and was analyzed at the NCI, according to the statement.
Chait said AnalizaDx was looking to partner with another, larger diagnostics company to help it commercialize its prostate cancer screening test and fund research into applying the test to other types of cancer. He said it’s likely the test would be available in about a year.
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Rather than sell the test to customers for use in their own labs, AnalizaDx and its partner will obtain samples from clients and perform the tests themselves in a CLIA setting, at least in the early commercialization phase. The company could later seek the regulatory approvals that would enable customers to perform the test themselves.
