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News and reporting on prostate cancer.
The nationwide study will enroll prostate cancer patients who do and don't meet current guidelines and assess how access to genetic information impacts their care.
The agency approved the test for use across solid tumors and with multiple companion diagnostic indications including one for prostate cancer and three for lung cancer.
The company said billable volume for its ConfirmMDx prostate cancer test fell 12 percent year over year, and volumes for its SelectMDx test fell 48 percent.
The firm said its genetic tests for breast, prostate, and colorectal cancers and melanoma assess a patient's personal cancer risks and guide personalized prevention.
The firm anticipates soon receiving FDA clearance for future products, including an AI-based prostate cancer detection system that received CE marking in 2019.
The company believes the pandemic will accelerate the adoption of its cancer diagnostics as patients and doctors look for faster and more convenient tests.
In a local coverage article, Medicare contractors in the MolDx program added prostate cancer to the covered indications for the test.
Opko's BioReference Laboratories business processed about 2.2 million COVID-19 molecular tests during the quarter, it said.
The firm reported that revenues from screening products fell 34 percent year over year, but that it took in $34.6 million in revenues from COVID-19 testing.
In a separate study, researchers studying the use of Oncotype DX in African-American men found it to be predictive of disease outcomes regardless of race.