Myriad GeneticsEdit
Myriad Genetics, Inc. is a biotechnology firm that became a cornerstone in the development and commercialization of molecular diagnostic tests. Its work in identifying inherited cancer risk, particularly through testing of the BRCA1 and BRCA2 genes, helped push the private sector to the forefront of precision medicine. The company built a substantial business around proprietary tests, data interpretation, and related services delivered through physician networks and insurers, illustrating how private investment can accelerate biomedical innovation and translate it into clinically actionable information for patients and families.
The BRCA testing program that Myriad pushed into the market became a focal point of a public policy dispute over whether human genes could be owned as intellectual property. In 2013, the Supreme Court resolved a central question by ruling that naturally occurring DNA sequences could not be patented, a decision that reshaped the patent landscape for biotechnology and altered the competitive dynamics in genetic testing. The court left room for patents on modified or synthetic DNA and for certain methods, which meant that firms could still protect some aspects of their technology, but the era of exclusive BRCA testing by a single company was effectively ended. The decision did not end Myriad’s role in the field, but it did compel the company to adjust its strategy to a more open competitive environment while continuing to monetize other differentiators such as data interpretation and broader testing menus.
From the outset, Myriad’s approach reflected a belief that strong intellectual property protections are essential to fund and sustain high-risk biomedical research, a stance often contrasted with calls for broader access and lower prices through open science or government-led initiatives. The result has been a persistent tension between the incentives created by patents and the demand for affordable, widely available tests. In the years after the BRCA decision, Myriad diversified its offerings beyond a single test and expanded into a wider set of hereditary cancer panels and pharmacogenomics, while also pursuing strategic collaborations and acquisitions to broaden its reach. A notable example was the acquisition of Counsyl, which extended Myriad’s reach into prenatal testing and family planning, illustrating how a data-driven diagnostics business often blends laboratory services with information-enabled care pathways. Counsyl
History and corporate development
Founding and early focus: Myriad was established to translate insights from genetics into clinically useful tests, with the BRCA1 and BRCA2 genes at the center of its early business model. The company pursued patents and developed the BRACAnalysis test, positioning itself as a leader in hereditary cancer risk assessment. BRCA1 BRCA2 BRACAnalysis
Patent portfolio and the litigation arc: Myriad held patents on naturally occurring BRCA sequences, enabling exclusive testing for a period. The legal challenge culminated in the 2013 decision in Association for Molecular Pathology v. Myriad Genetics, Inc., which ruled that such natural DNA sequences could not be patented, reshaping incentives and competition in the diagnostic test market. The ruling preserved some patentable avenues, such as synthetic or modified DNA (e.g., cDNA), and certain testing methods, but limited the ability to patent raw gene sequences. gene patent cDNA DNA sequencing
Diversification and growth: In response to a more open market environment, Myriad broadened its test menu beyond BRCATesting to other hereditary cancer risks and related conditions, emphasizing data interpretation and clinical utility. The company also pursued partnerships and acquisitions to strengthen its position in adjacent domains, including prenatal testing. The 2018 acquisition of Counsyl expanded its footprint in noninvasive prenatal testing and family-history-based decision support, aligning with a broader strategy of combining laboratory services with data-driven care pathways. Counsyl genetic testing prenatal testing
Regulatory and policy context: The regulatory landscape for diagnostic tests includes oversight considerations for laboratory-developed tests and manufacturing standards. The dialogue around how best to balance innovation incentives with patient access has featured prominent debates about the proper scope of federal involvement, reimbursement frameworks, and the role of private data in clinical decision-making. Related topics include the Food and Drug Administration (FDA) role, the Clinical Laboratory Improvement Amendments (CLIA) framework, and the protections offered by the Genetic Information Nondiscrimination Act (GINA). FDA CLIA Genetic Information Nondiscrimination Act
Market position and ongoing relevance: Today, Myriad remains a significant player in the molecular diagnostics industry, continuing to offer hereditary cancer testing, pharmacogenomics, and related services, while navigating a landscape in which competitors and new entrants provide alternative panels and testing approaches. The company’s approach underscores a broader industry pattern: private firms rely on a mix of proprietary tests, clinician engagement, data interpretation tools, and strategic acquisitions to maintain relevance as technology and guidelines evolve. genetic testing pharmacogenomics
The BRCA patents and litigation
The core controversy around Myriad’s BRCA testing rested on whether human gene sequences could be owned as exclusive property. The 2013 Supreme Court decision held that the natural DNA sequences of BRCA1 and BRCA2 could not be patented, which opened the door for other labs to offer BRCA testing and intensified competition on price and service. However, the court also left room for protection of other intellectual property tied to diagnostics, including cDNA and certain methods, which allowed firms to pursue alternative pathways to protect investment where appropriate. This nuanced ruling reflected a balance between incentivizing discovery and preventing monopolies on naturally occurring biological material. BRCA1 BRCA2 cDNA gene patent
The immediate effect was a shift in market dynamics. Myriad could not rely solely on gene patents to secure exclusive market share for BRCA testing, which encouraged competition and potentially lower costs for patients, though the company continued to leverage its expertise in data interpretation, panel design, and related services to preserve value. The broader policy conversation extended beyond one company, shaping how researchers, insurers, and regulators think about the ownership of genetic information and the creation of value from genomic data. genetic testing patent law
Diversification, strategy, and public policy
Myriad’s response to a more competitive environment illustrates a general pattern in the life sciences: firms diversify to defend growth trajectories, moving into larger panels, data analytics, and adjacent diagnostic areas. The Counsyl acquisition is a notable example of moving into prenatal testing and family-planning support, which complements hereditary risk assessment and expands payer engagement opportunities. In a healthcare market driven by cost, coverage decisions, and patient access, private diagnostics companies argue that robust intellectual property and clear data ownership are essential to sustain ongoing invention and clinical innovation. Critics of IP-centric models counter that patient access should take precedence and that competition should be fostered to drive down prices; proponents respond that a strong IP framework is what funded the initial discovery and the costly process of clinical validation. In practice, the balance between these positions shapes policy proposals, reimbursement rules, and how new tests are evaluated for clinical utility. Counsyl genetic testing healthcare policy patent law intellectual property
Public discussion around genetic testing also touches on privacy and data use. Genetic data can yield insights into disease risk but raises questions about how information is stored, shared, and used by clinicians, laboratories, and third parties. Legal protections such as the Genetic Information Nondiscrimination Act and privacy practices in medical research and clinical care influence how patients experience testing and how firms manage data assets. The regulatory environment, including the FDA’s jurisdiction over diagnostic tests and the CLIA framework for laboratory operations, continues to shape how Myriad and its peers innovate and deliver services. FDA CLIA Genetic Information Nondiscrimination Act
See also - BRCA1 - BRCA2 - BRCA testing - Association for Molecular Pathology v. Myriad Genetics, Inc. - Counsyl - pharmacogenomics - genetic testing - DNA sequencing - Genetic Information Nondiscrimination Act - Intellectual property - FDA - Laboratory-developed test - Clinical Laboratory Improvement Amendments