Company: MYGN
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000899923-25-000019
Chunk: 55

Company: MYRIAD GENETICS INC
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1A
Chunk 55
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 develop relationships with a competitor, our ability to discover genes, proteins, and biomarkers, and to validate and commercialize tests could be adversely affected.

Risks Related to Our Intellectual Property

•If we fail to protect our proprietary technology, others could compete against us more directly, which would harm our business.

•If we are subject to litigation or other proceedings arising from a claim of infringement of the intellectual property of a third party, we might incur significant costs and delays in test introduction or we could be prevented from using technologies incorporated in our tests.

•If we fail to comply with our obligations under license or technology agreements with third parties, we could lose license rights that are critical to our business.

•We may be subject to claims that we or our employees have wrongfully used or disclosed alleged trade secrets.

•If we fail to adequately protect our trademarks, service marks, trade names and trade dress, we may lose goodwill and brand equity associated with our business.

Risks Related to Government Regulation

•If we fail to comply with the complex federal, state, local and foreign laws and regulations that apply to our business, we could suffer consequences that could materially and adversely affect our operating results and financial condition.

•Our actual or perceived failure to comply with data protection laws and regulations could lead to complaints, government enforcement actions, private litigation, and/or adverse publicity and could negatively affect our business.

•We may from time to time be subject to government investigation(s), the unfavorable outcome of which may have a material adverse effect on our financial condition, results of operations and cash flows. 

•Changes in health care policy could increase our costs, decrease our revenue and impact sales of and reimbursement for our tests.

•Our business could be harmed by the loss, suspension, or other restriction on a license, certification, or accreditation, or by the imposition of a fine or penalties, under CLIA, its implementing regulations, or other state, federal and foreign laws and regulations affecting licensure or certification, or by future changes in these laws or regulations.

•Planned changes in the way the FDA regulates tests performed by laboratories like ours will result in delay and/or additional expense in offering our tests and tests that we may develop in the future.

•FDA regulation of our GeneSight Psychotropic test could be disruptive to our business.

•Companion and complementary diagnostic tests require FDA approval, and we may not be able to secure such approval in a timely manner or at all. 

•Our companion diagnostic tests are subject to ongoing regulatory compliance obligations and continued regulatory review and