Risk Factors Update Summary
- The California Privacy Rights Act (CPRA) went into effect on January 1, 2023, significantly impacting compliance costs.
- Delayed PAMA reporting period for CDLTs to January 1, 2025, through March 31, 2025.
- New comprehensive privacy laws in Virginia, Colorado, Connecticut, and Utah took effect in 2023.
- Further delayed application of 15% phase-in reduction under PAMA to January 1, 2025.
- FDA proposed a rule in October 2023 to regulate LDTs under the medical device framework.
- Increased maximum principal amount under ABL Facility by $25.0 million to $115.0 million.
- Settlement agreement with Ravgen requiring minimum payments of $12.75 million and potential $21.25 million.
- Completed public offering of common stock, selling 7,441,176 shares at $17.00 per share for $117.6 million.
- Ongoing transition of laboratory operations to new facilities in Salt Lake City, Utah, and South San Francisco, California.
- Potential impact of global supply chain disruptions due to hostilities in Ukraine and the Middle East.
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.
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