OPKO Health
A publicly traded healthcare company combining biopharmaceutical development with clinical diagnostics.
Last updated August 31, 2026
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Overview
OPKO Health, Inc. is a diversified healthcare company whose activities span biopharmaceutical development, clinical laboratory services, diagnostic testing, and commercialization of specialty medicines. The company is headquartered in Miami, Florida, and operates internationally, with business interests in the United States, Israel, and other markets. Its shares trade on Nasdaq and the Tel Aviv Stock Exchange under the symbol OPK. The company’s diagnostics operations include BioReference Laboratories, a clinical laboratory business with a significant focus on genetic and molecular testing. OPKO is also associated with the 4Kscore, a blood-based test intended to help assess the risk of aggressive prostate cancer and support decisions about whether a prostate biopsy may be appropriate. These diagnostic activities give OPKO exposure to laboratory medicine and precision-health applications in addition to traditional drug development. On the pharmaceutical side, OPKO has developed and commercialized products addressing specialized medical needs. Rayaldee is associated with the management of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and vitamin D insufficiency. Varubi, also known as rolapitant, is an antiemetic used in connection with chemotherapy-induced nausea and vomiting. The company’s portfolio and development work have emphasized areas such as renal disease, oncology, and other conditions where diagnostic information and targeted therapies may complement one another. OPKO has expanded through acquisitions and technology transactions as well as internal research and development. In May 2022, it announced the acquisition of ModeX Therapeutics for approximately $300 million. The transaction added proprietary immunotherapy technology directed toward infectious diseases and oncology, broadening OPKO’s development platform beyond its existing marketed products and diagnostics. Phillip Frost has been the company’s chairman and chief executive officer. OPKO’s overall model is that of a diversified healthcare platform rather than a single-product pharmaceutical company: laboratory infrastructure, proprietary diagnostic tests, marketed medicines, and early- and mid-stage biotechnology assets are combined within one publicly listed group. The company remains active, although the available reference material does not provide a complete current breakdown of revenue, geographic sales, or the status of every development program.
History
OPKO Health developed as a diversified healthcare company rather than as a narrowly focused single-drug business. Founded in 2007, it built a platform spanning diagnostic testing, clinical laboratory operations, pharmaceutical products, and biotechnology development. Its corporate strategy has been associated with identifying medical areas in which proprietary testing, specialized treatments, or platform technologies can address important clinical needs. A major part of the company’s diagnostic presence comes from BioReference Laboratories. BioReference is a clinical laboratory business with a substantial genetic-testing and molecular-diagnostics component. Through this activity, OPKO participates in laboratory medicine and in the use of genetic information to support diagnosis, risk assessment, and treatment decisions. The company is also associated with the 4Kscore, a blood test for prostate cancer risk assessment. The test is designed to help distinguish men at higher risk of aggressive disease and can be used as information in evaluating whether additional procedures, including biopsy, should be considered. OPKO’s pharmaceutical business has included products in renal disease and supportive oncology care. Rayaldee is a vitamin-D-related prescription product used for adults with stage 3 or 4 chronic kidney disease and vitamin D insufficiency in the management of secondary hyperparathyroidism. Varubi, or rolapitant, is an antiemetic product used to help prevent chemotherapy-induced nausea and vomiting. These products illustrate OPKO’s emphasis on specialty areas in which treatment is directed at defined patient populations or specific complications of serious disease. The company has also pursued biotechnology assets and acquisitions to expand its research base. In May 2022, OPKO announced the acquisition of ModeX Therapeutics for approximately $300 million. ModeX brought proprietary immunotherapy technology intended for applications in infectious diseases and oncology. The transaction strengthened OPKO’s position in therapeutic-platform development and complemented its existing interests in cancer-related diagnostics and medicines. OPKO operates internationally and has been described as having a presence in more than 30 countries, although the available reference material does not supply a detailed country-by-country operating map. The company is publicly traded on Nasdaq and the Tel Aviv Stock Exchange under the symbol OPK. Phillip Frost is identified as chairman and chief executive officer. The company has also faced regulatory litigation. In September 2018, the SEC filed a complaint naming OPKO, Frost, and other parties. The matter was resolved through settlements entered into in December 2018 and approved by the court in January 2019. OPKO agreed to an injunction relating to Section 13(d) of the Exchange Act and paid a $100,000 penalty, without admitting or denying the allegations. A subsequent amended complaint was filed in March 2019. The matter is a significant governance and regulatory episode in the company’s public record, but the available references do not establish broader findings beyond the settlement terms described above. Today, OPKO is best characterized as an integrated healthcare company combining clinical diagnostics, laboratory infrastructure, marketed specialty products, and biotechnology research. Its portfolio is particularly connected with renal disease, prostate-cancer assessment, oncology, infectious disease, and laboratory-based medicine.
- 2022
ModeX Therapeutics acquisition announced
[1]OPKO announces the approximately $300 million acquisition of ModeX Therapeutics, adding immunotherapy technology for infectious disease and oncology applications.
- 2019
SEC settlement is approved
[1]OPKO and Frost settle the SEC matter without admitting or denying the allegations; OPKO agrees to an injunction and pays a $100,000 penalty.
- 2018
SEC litigation is filed
[1]The SEC files a lawsuit naming OPKO Health, Phillip Frost, and other parties in connection with alleged securities-law violations.
- 2007
OPKO Health is founded
[1]OPKO Health is established as a healthcare company focused on diagnostics, pharmaceuticals, and biotechnology activities.
Products and positioning
A diversified healthcare platform focused on specialized medicines, laboratory diagnostics, and technologies addressing unmet needs in renal disease, oncology, infectious disease, and precision medicine.
Clinical laboratory and diagnostics
BioReference Laboratories
BioReference Laboratories is OPKO’s clinical laboratory business. It provides laboratory testing with a notable emphasis on genetic and molecular diagnostics. The business gives OPKO an operating base in clinical laboratory medicine and supports the company’s broader interest in using diagnostic information to guide clinical decisions.
Prostate-cancer diagnostic test
4Kscore
The 4Kscore is a blood test used to assess a man’s risk of aggressive prostate cancer. It combines laboratory measurements and clinical information to provide risk-assessment data that may help physicians decide whether further evaluation, including prostate biopsy, is warranted.
Renal-disease prescription medicine
Rayaldee
Rayaldee is a prescription product associated with the management of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and vitamin D insufficiency. It represents OPKO’s specialty-pharmaceutical focus in renal medicine and addresses a complication connected with impaired kidney function.
Supportive oncology medicine
Varubi
Varubi, also known as rolapitant, is an antiemetic medicine used in connection with chemotherapy-induced nausea and vomiting. The product extends OPKO’s pharmaceutical interests into supportive oncology care, complementing the company’s broader involvement in oncology-related diagnostics and biotechnology.
Biotechnology platform
ModeX immunotherapy technology
ModeX’s proprietary immunotherapy technology became part of OPKO through the 2022 acquisition of ModeX Therapeutics. The platform is directed toward potential applications in infectious diseases and oncology and represents a research and development asset rather than a single established commercial product.
Controversies
2019
Settlement of SEC claims
In December 2018, OPKO and Frost entered into settlements with the SEC. Court approval followed in January 2019. Without admitting or denying the allegations, OPKO accepted an injunction concerning Section 13(d) and paid a $100,000 penalty.
2018
SEC lawsuit concerning OPKO and Phillip Frost
The SEC filed a lawsuit on September 7, 2018, naming OPKO Health, chairman and CEO Phillip Frost, and other individuals and entities. The case included allegations involving Section 13(d) of the Exchange Act.
Brand decisions
2022
Acquire ModeX TherapeuticsM&ABackground
OPKO sought to expand its biotechnology capabilities and add therapeutic-platform technology alongside its diagnostic and pharmaceutical businesses.
Action taken
OPKO announced the acquisition of U.S.-based ModeX Therapeutics for approximately $300 million, gaining proprietary immunotherapy technology for infectious-disease and oncology applications.
Aftermath
The transaction broadened OPKO’s research and development platform, although the available reference material does not provide subsequent product approvals or commercial outcomes for the acquired technology.
Announced acquisition value. Approximately $300 million transaction value (May 2022)
Recent events
OPKO Health appoints Roger Medel to its board[3]
Reported:
OPKO Health announced that Roger Medel, M.D. was appointed as an independent member of its Board of Directors, effective December 18, 2020.
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