Opko Health Inc. (NASDAQ:OPK) has announced the receipt of US FDA approval for its point-of-care Sangia Total Prostate Specific Antigen (PSA) Test with the help of Claros 1 Analyzer. The healthcare professional collects the blood using a fingerstick and measures the total PSA. They conduct the test together with a digital rectal exam to detect prostate cancer in men aged above 50 years. The stock gained 3.28% in the last trading session to close at $2.83.
Annual PSA tests in the US at 25 million
The annual PSA tests in the US is estimated at 25 million. Opko plans to expand assays on Claros 1 technology for future submissions to the US FDA. It will also conduct testosterone tests by the end of this year. CEO and Chairman of Opko, Philip Frost said the company is happy in getting the nod of FDA for the point of care Sangia PSA Test using Claros 1 Analyzer. Dr. Frost said PSA Test provides the results in a clinic to accurately diagnose prostate cancer.
Quantitative test results in just 10 minutes
The innovative diagnostic test instrument system – Claros 1 technology analyzer provides the quantitative results in only under 10 minutes. It has the size of a disposable test cassette. The instrument has the latest microfluidic technology. The test does not require the preparation of blood samples or external reagents. The Carlos 1 Analyzer comprises microfluidic assay cassette.
Opko suspends the trial of OPK-88004
Opko has suspended the phase 2 clinical trial of OPK-88004 in men suffering from BPH (Benign Prostate Hyperplasia) following the disappointing results.
Opko unveils Q3 2018 results
The net loss of Opko has reduced to $27.7 million from $35.9 million in the same quarter of the previous year. Its total revenues surged to $249.8 million in Q3 2018 when compared to $246 million for the same quarter a year ago.
Highlights of the business
According to IMS, the total RAYALDEE prescriptions surged by 222% when compared to the same quarter in 2017. Around 79% of the patients got access to the RAYALDEE under the insurance plan. The company will conduct the efficacy and safety test of RAYALDEE in a phase 2 trial to treat secondary hyperparathyroidism in men suffering from Vitamin D deficiency.