Risk Factors Update Summary
- Added new sanctions imposed by the United States, increasing geopolitical risks, especially in Israel.
- Revenue decline of $36 million to $74 million in 2023, with an accumulated deficit increase from $393 million to $468 million.
- Integration of AI and machine learning poses risks of brand harm, legal liability, and increased costs.
- Medicare funding reduced to 20% and 10% of total revenue for 2023 and 2022, down from 30% and 10% in 2021.
- Increased uncertainty due to the conflict in Ukraine affecting operations and business continuity.
- Proposed LCD for "Molecular Testing for Risk Stratification of Thyroid Nodules" issued in August 2023.
- Delay in reporting period to 2025 for payment rates based on 2017 reporting, affecting reimbursement rate effective January 1, 2029.
- New LCD issued for "Gene Expression Profile Tests for Decision-Making in Prostate Cancers" in August 2023.
- New CPT code 81542 assigned for Prosigna in 2020, impacting reimbursement rates effective January 1, 2029.
- Medicare coverage issued for Envisia Genomic Classifier with a payment rate of $500 in 2024.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=1384101&owner=exclude
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