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OPKO OPKO Health Reports 2021 Third Quarter Business Highlights and Financial Results October 28 , 2021 Conference call begins at 4:30 p.m. Eastern time today MIAMI , Oct. 28 , 2021 ( GLOBE NEWSWIRE ) -- OPKO Health , Inc. ( NASDAQ : OPK ) reports business highlights and financial results for the three months ended September 30 , 2021 . Business Highlights • Health Canada approved NGENLATM ( somatrogon ) injection for pediatric growth hormone deficiency . NGENLA is a once - weekly , long - acting recombinant human growth hormone , for the long - term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone ( growth hormone deficiency , or GHD ) . Please click here to view Pfizer Canada's news release issued earlier today . Global regulatory applications for somatrogon continue to advance with action dates in the U.S. , Europe and Japan expected during the first half of 2022 . • BioReference Laboratories ( BRL ) processed approximately 2.2 million COVID - 19 PCR tests in the third quarter of 2021. In addition , during the quarter BRL performed approximately 158,100 COVID - 19 serology tests to measure SARS - CoV - 2 antibody levels and currently has significant additional capacity . In August 2021 Rite Aid , the U.S. Department of Health and Human Services , and BRL announced a " Back to School " COVID - 19 testing program offering students at New York State public schools the opportunity for free COVID - 19 testing prior to or at the start of the 2021-2022 school year . Students will be tested using highly accurate RT - PCR laboratory - based COVID - 19 tests . • BRL acquired the U.S. Ariosa centralized laboratory prenatal testing business from Roche . Ariosa's noninvasive prenatal screening ( NIPS ) test , the Harmony Prenatal Test , is one of the most widely studied tests utilized in prenatal screening . This test has been performed in more than 1.5 million patients . The acquisition of Ariosa will complement the current NIPS offering at GenPath , BRL's specialty health division . • Completed enrollment in Phase 2 trial evaluating RAYALDEE® as a treatment for symptomatic COVID - 19 outpatients . The U.S. trial , “ A Randomized , Double - Blind Placebo - Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE ( calcifediol ) Extended - release Capsules to Treat Symptomatic Patients Infected with SARS - CoV - 2 , " completed final enrollment with 171 subjects , including some with stage 3 or 4 chronic kidney disease who are at higher risk for developing more severe illness . Topline data are expected later this year .