Company: VCYT
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0001384101-25-000014
Chunk: 78

Company: VERACYTE, INC.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1A
Chunk 78
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 subject to similar regulatory regimes of foreign jurisdictions as we continue to commercialize our products in new markets outside of the United States and Europe. Adverse actions in any of these areas could significantly increase our expenses and limit our revenue and profitability.

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If we are unable to compete successfully, we may be unable to increase or sustain our revenue and profitability.

We operate in a highly competitive market.  Growing understanding of the importance of biomarkers linked with therapy selection, response and early screening is leading to more companies offering services in genomic profiling which may lead to increased competition for our tests. 

Our Decipher Prostate test faces competition from Myriad Genetics and MDx Health, which offer genomic testing for prognostic purposes within localized prostate cancer. Traditional methods used by pathologists and clinicians to estimate risk of disease progression also pose competitive threats to our business. In addition, we may face increased competition from companies that combine traditional pathology methods and new technologies such as AI and digital pathology, such as the ArteraAI Prostate Test. Technological development by others may result in our technologies, as well as tests developed using our technologies, becoming obsolete. Our competitors may be able to develop competing or superior technologies and processes and compete more aggressively and sustain that competition over a longer period of time. See “If we are unable to develop products to keep pace with rapid technological, medical and scientific change, our operating results and competitive position could be harmed.” 

We are not currently aware of a direct competitor offering genomic testing for prognostic purposes that matches the intended use population for the Decipher Bladder test. DNA mutational analysis and traditional clinical methods and nomograms are currently in use by physicians for similar purposes, which have been used for many years and therefore may be difficult to displace or supplement. To compete successfully, we must be able to demonstrate, among other things, that our diagnostic test results are accurate and cost effective.

For our Afirma genomic classifier we face competition from companies and academic institutions that use NGS technology or other methods to measure mutational markers such as BRAF and KRAS, along with numerous other mutations. These organizations include Interpace Diagnostics Group, Inc., ThyroSeq (marketed by Sonic Healthcare Limited) and others who are developing new products or technologies that may compete with our tests. 

For the Percepta Nasal Swab test, we expect competition from companies focused on lung cancer such as Biodesix, Inc. We believe our principal competitor in the breast cancer diagnostics market is Exact Sciences Corporation, which currently commands a