21. Subsequent Events

LCD Update

On January 9, 2025, the Company announced the new LCD established non-coverage for its PancraGEN^® test, and it would stop offering the test and would not accept specimens for first-line fluid chemistry and PancraGEN^® testing after February 7, 2025. As a result of the established non-coverage for PancraGEN^®, the Company announced that its board of directors had approved a restructuring and cost-savings plan to reduce operating costs and better align the Company workforce with the loss of PancraGEN^®.

On January 27, 2025, the Company announced that CMS had directed its Medicare Administrative Contractors, Novitas and First Coast Service Options, Inc., to delay implementation of the Genetic Testing for Oncology LCD (L39365), from February 23, 2025 until April 24, 2025. The Company stated that this change of effective date will allow the Trump administration time to fully review the proposed policy changes, re-evaluate for themselves the supporting clinical evidence for the PancraGEN^® assay, and fully assess the negative impact on patient care if the currently proposed LCD comes into effect.

BroadOak Amendment

On January 14, 2025, the Company entered into a Fourth Amendment to the Loan and Security Agreement with BroadOak, extending the loan maturity date to December 31, 2025. The primary changes to the Third Amendment were as follows: