Opko gets FDA OK for fingerstick test, seeks reversal on non-coverage ruling
By Emon Reiser – Digital Producer, South Florida Business Journal
Feb 1, 2019, 2:15pm EST
Opko Health Inc. on Friday announced that the U.S. Food and Drug Administration (FDA) approved its fingerstick test for prostate cancer using its Claros 1 Analyzer. But the Miami-based medical test and pharmaceutical company has hit a roadblock for its signature biotechnology, the 4Kscore.
The FDA-approved test can measure elevated levels of Prostate Specific Antigen (PSA) — which could indicate a number of issues with the prostate, including prostate cancer — via blood collected from the Claros 1 Analyzer fingerstick by a health care professional and used along with a digital rectal exam. The diagnostic test produces results in 10 minutes when administered at a physician's office, the company said.
Opko expects to expand on the test's capabilities, such as measuring testosterone levels, later this year.
"This approval contributes to our growing urology franchise and affords us the momentum to expand the test menu on the Claros 1 technology platform in the future,” Dr. Phillip Frost, the billionaire CEO of Opko, said. “We believe that a PSA test that provides results in the physician’s office will significantly benefit the diagnostic paradigm for prostate cancer."
Shortly before it announced a green light from the FDA on the test, Opko said it would evaluate options to appeal a non-coverage determination for its 4Kscore ahead of submitting the test to the FDA in the next quarter.
The 4Kscore test, which Frost sees as a defining development for Opko, identifies men at higher risk of aggressive prostate cancer and also those with low risk, which could prevent men from undergoing unnecessary biopsies while reducing waste in the nation's health care system.
Novitas Solutions, which determines what treatments Medicare should cover in 10 states and Washington, D.C., issued a proposed ruling May 2018 that Medicare should not reimburse for the 4Kscore because it found flaws with clinical studies into the effectiveness of the tests. Novitas is the Medicare Administration Contractor for New Jersey, where Opko's BioReference Laboratories is located and all 4Kscore test samples are processed.
On Thursday night, Opko said that Novitas recently issued a future non-coverage determination for the 4Kscore test that would be effective March 20 that is not different from the local coverage determination issued last year. That means the 4Kscore, Opko's key product, would not be covered by many public health programs.
"We remain committed to our goal of widespread and affordable access to 4Kscore," Frost said.
More than 12,000 practicing physicians have ordered the 4Kscore test, the company said. Opko will attempt an appeal on the decision with the U.S. Centers for Medicare & Medicaid Services.
There are 25 million PSA tests performed in the U.S. annually.
By Emon Reiser – Digital Producer, South Florida Business Journal
Feb 1, 2019, 2:15pm EST
Opko Health Inc. on Friday announced that the U.S. Food and Drug Administration (FDA) approved its fingerstick test for prostate cancer using its Claros 1 Analyzer. But the Miami-based medical test and pharmaceutical company has hit a roadblock for its signature biotechnology, the 4Kscore.
The FDA-approved test can measure elevated levels of Prostate Specific Antigen (PSA) — which could indicate a number of issues with the prostate, including prostate cancer — via blood collected from the Claros 1 Analyzer fingerstick by a health care professional and used along with a digital rectal exam. The diagnostic test produces results in 10 minutes when administered at a physician's office, the company said.
Opko expects to expand on the test's capabilities, such as measuring testosterone levels, later this year.
"This approval contributes to our growing urology franchise and affords us the momentum to expand the test menu on the Claros 1 technology platform in the future,” Dr. Phillip Frost, the billionaire CEO of Opko, said. “We believe that a PSA test that provides results in the physician’s office will significantly benefit the diagnostic paradigm for prostate cancer."
Shortly before it announced a green light from the FDA on the test, Opko said it would evaluate options to appeal a non-coverage determination for its 4Kscore ahead of submitting the test to the FDA in the next quarter.
The 4Kscore test, which Frost sees as a defining development for Opko, identifies men at higher risk of aggressive prostate cancer and also those with low risk, which could prevent men from undergoing unnecessary biopsies while reducing waste in the nation's health care system.
Novitas Solutions, which determines what treatments Medicare should cover in 10 states and Washington, D.C., issued a proposed ruling May 2018 that Medicare should not reimburse for the 4Kscore because it found flaws with clinical studies into the effectiveness of the tests. Novitas is the Medicare Administration Contractor for New Jersey, where Opko's BioReference Laboratories is located and all 4Kscore test samples are processed.
On Thursday night, Opko said that Novitas recently issued a future non-coverage determination for the 4Kscore test that would be effective March 20 that is not different from the local coverage determination issued last year. That means the 4Kscore, Opko's key product, would not be covered by many public health programs.
"We remain committed to our goal of widespread and affordable access to 4Kscore," Frost said.
More than 12,000 practicing physicians have ordered the 4Kscore test, the company said. Opko will attempt an appeal on the decision with the U.S. Centers for Medicare & Medicaid Services.
There are 25 million PSA tests performed in the U.S. annually.