FDA OKs Blood-Based Test to Help Diagnose Prostate Cancer

The FDA has granted Cleveland Diagnostics' IsoPSA test premarket approval (PMA) to help detect prostate cancer in men aged ≥ 50 years with elevated PSA levels.

IsoPSA is a blood assay that detects variations of the PSA protein that signal a higher likelihood of high-grade tumors. It is one of several biomarker tests included in the National Comprehensive Cancer Network's guidelines on early detection of prostate cancer.

Cleveland Diagnostics noted that 75% of prostate biopsies are negative for high-grade disease. IsoPSA and similar tests aim to help identify men who need a biopsy while allowing others avoid an unnecessary procedure.

IsoPSA has been available since 2020 under the FDA's Laboratory-Developed Test rubric, meaning that blood samples had to be shipped for analysis to Cleveland Diagnostics' lab. With the PMA, testing can now be done at CLIA-certified labs across the country.

The company expects the approval should increase access to IsoPSA and reduce turnaround time. "We remain focused on executing our commercial strategy and expanding access to IsoPSA," company President and CEO Arnon Chait, PhD, said in a press release.

The approval was based, in part, on a prospective validation study of 888 men scheduled for prostate biopsy. IsoPSA demonstrated an AUC of 0.783 for high-grade tumors, with a sensitivity of 90.2% and a specificity of 45.5%. In a real-world clinical utility study with 900 patients, IsoPSA testing led to a 55% decrease in biopsy recommendations.

The test is covered by Medicare and a growing number of commercial payers, Cleveland Diagnostics said.

M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape Medical News. Alex is also an MIT Knight Science Journalism Fellow. Email: [email protected].

A version of this article first appeared on Medscape.com.

The FDA has granted Cleveland Diagnostics' IsoPSA test premarket approval (PMA) to help detect prostate cancer in men aged ≥ 50 years with elevated PSA levels.

IsoPSA is a blood assay that detects variations of the PSA protein that signal a higher likelihood of high-grade tumors. It is one of several biomarker tests included in the National Comprehensive Cancer Network's guidelines on early detection of prostate cancer.

Cleveland Diagnostics noted that 75% of prostate biopsies are negative for high-grade disease. IsoPSA and similar tests aim to help identify men who need a biopsy while allowing others avoid an unnecessary procedure.

IsoPSA has been available since 2020 under the FDA's Laboratory-Developed Test rubric, meaning that blood samples had to be shipped for analysis to Cleveland Diagnostics' lab. With the PMA, testing can now be done at CLIA-certified labs across the country.

The company expects the approval should increase access to IsoPSA and reduce turnaround time. "We remain focused on executing our commercial strategy and expanding access to IsoPSA," company President and CEO Arnon Chait, PhD, said in a press release.

The approval was based, in part, on a prospective validation study of 888 men scheduled for prostate biopsy. IsoPSA demonstrated an AUC of 0.783 for high-grade tumors, with a sensitivity of 90.2% and a specificity of 45.5%. In a real-world clinical utility study with 900 patients, IsoPSA testing led to a 55% decrease in biopsy recommendations.

The test is covered by Medicare and a growing number of commercial payers, Cleveland Diagnostics said.

M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape Medical News. Alex is also an MIT Knight Science Journalism Fellow. Email: [email protected].

A version of this article first appeared on Medscape.com.

The FDA has granted Cleveland Diagnostics' IsoPSA test premarket approval (PMA) to help detect prostate cancer in men aged ≥ 50 years with elevated PSA levels.

IsoPSA is a blood assay that detects variations of the PSA protein that signal a higher likelihood of high-grade tumors. It is one of several biomarker tests included in the National Comprehensive Cancer Network's guidelines on early detection of prostate cancer.

Cleveland Diagnostics noted that 75% of prostate biopsies are negative for high-grade disease. IsoPSA and similar tests aim to help identify men who need a biopsy while allowing others avoid an unnecessary procedure.

IsoPSA has been available since 2020 under the FDA's Laboratory-Developed Test rubric, meaning that blood samples had to be shipped for analysis to Cleveland Diagnostics' lab. With the PMA, testing can now be done at CLIA-certified labs across the country.

The company expects the approval should increase access to IsoPSA and reduce turnaround time. "We remain focused on executing our commercial strategy and expanding access to IsoPSA," company President and CEO Arnon Chait, PhD, said in a press release.

The approval was based, in part, on a prospective validation study of 888 men scheduled for prostate biopsy. IsoPSA demonstrated an AUC of 0.783 for high-grade tumors, with a sensitivity of 90.2% and a specificity of 45.5%. In a real-world clinical utility study with 900 patients, IsoPSA testing led to a 55% decrease in biopsy recommendations.

The test is covered by Medicare and a growing number of commercial payers, Cleveland Diagnostics said.

M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape Medical News. Alex is also an MIT Knight Science Journalism Fellow. Email: [email protected].

A version of this article first appeared on Medscape.com.