Cancer test developer Cleveland Diagnostics on Monday announced an agreement with Quest Diagnostics to broaden access to the IsoPSA prostate cancer test.
IsoPSA, a blood-based test, demonstrated better diagnostic accuracy than prostate-specific antigen (PSA) testing, the current standard of care in prostate cancer diagnosis, in a large, multicenter study, according to Cleveland Diagnostics.
The firm uses IsoPSA as a laboratory-developed test at its high-complexity, CLIA-certified, CAP-accredited laboratory in Cleveland.
For the time being, tests ordered through the Quest network will be processed in the Cleveland laboratory.
The parties expect physicians will begin ordering the test for patients through Quest Diagnostics in the second quarter. When physicians order the test, their patients will provide blood samples at a Quest Diagnostics’ patient service center. Quest will then transport the blood samples for testing at the Cleveland Diagnostics laboratory.
The IsoPSA test helps predict risk by interrogating the partitioning behavior of isoforms of PSA that are linked to cancer. It is used in the triaging of patients at risk for high-grade prostate cancer, and provides insights into whether a patient's elevated levels of prostate-specific antigen (PSA) are due to high-grade cancer or a different condition. These insights help a physician decide whether a patient needs a prostate biopsy, Cleveland Diagnostics noted.
Financial and other terms of the collaboration agreement with Quest were not disclosed.