BIODESIX INC

Current report

Changes in payer reimbursement policies, claims review practices and broader healthcare policy and enforcement priorities may affect coverage, reimbursement rates, and the timing and amount of payment for our tests.

Current report

Changes in payer reimbursement policies, claims review practices and broader healthcare policy and enforcement priorities, including initiatives focused on fraud and abuse such as the Trump Administration’s CMS Request for Information for a potential forthcoming “CRUSH” rule focused on strengthening program integrity across federal healthcare programs, may affect coverage, reimbursement rates and the timing and amount of payment for our tests. Such changes may also increase administrative burdens and lead to additional denials, payment delays, recoupments or refund requests, any of which could adversely affect our revenue and results of operations. Because payer policies and enforcement priorities can change rapidly and vary across jurisdictions and payers, the ultimate impact of these developments on our business and financial performance remains uncertain.

Previous report

Our business could be adversely affected by a prolonged federal government shutdown, particularly if it results in interruptions to Medicare, Medicaid, or other federally funded healthcare programs.

Previous report

Our business could be adversely affected by a prolonged federal government shutdown, particularly if it results in interruptions to Medicare, Medicaid, or other federally funded healthcare programs. These programs represent a significant portion of our revenue, and any delay in payments, coverage decisions, or patient access could materially impact our financial results. Additionally, a shutdown may delay regulatory approvals and hinder our ability to launch new products, further affecting our growth prospects.

Previous report

There can be no assurance that our common stock will maintain compliance with the minimum bid price requirement or other applicable listing standards of The Nasdaq Stock Market LLC or another national securities exchange.

Previous report

There can be no assurance that we will be able to continue to meet The Nasdaq Global Market listing standards. We have in the past, and may in the future, be unable to comply with certain of the listing standards that we are required to meet to maintain the listing of our common shares on The Nasdaq Global Market. If we are unable to maintain compliance with all applicable listing standards, our common stock may no longer be listed on The Nasdaq Global Market or another national securities exchange and the liquidity and market price of our common stock may be adversely affected.

Previous report

On March 24, 2025, we received written notice from the Staff of Nasdaq notifying us that we no longer complied with the minimum bid price requirement for continued listing on The Nasdaq Global Market. On September 15, 2025, we effected a 1-for-20 reverse stock split and on September 26, 2025, we received a letter from the Staff notifying us that we had regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Global Market, and the matter is now closed.

Previous report

If in the future we fail to meet Nasdaq’s continued listing requirements and Nasdaq delists our common stock from trading on its exchange and we are not able to list our securities on another national securities exchange, we could face significant material adverse consequences, including, without limitation, a substantial reduction in the liquidity of our common stock, which could limit our access to capital markets for any potential future fundraising.

Previous report

There is currently significant uncertainty about the future relationship between the U.S. and various other countries with respect to trade policies, treaties, tariffs and taxes. Current or future tariffs imposed by the U.S. may negatively impact our business. During 2025, the U.S. presidential administration has threatened and imposed significant tariffs on imports from various countries, and has indicated that additional tariffs may be imposed in the future. In response, some of these countries have announced or imposed tariffs on imports from the U.S. The duration for which enacted tariffs will be in place remain uncertain and protracted trade disputes could lead to economic decline, which could negatively impact our results of operations.

Previous report

FDA is phasing out its general policy of enforcement discretion and will regulate laboratory developed tests as medical devices.

Previous report

The laws and regulations governing the marketing of diagnostic products are evolving, extremely complex and in many instances, there are no significant regulatory or judicial interpretations of these laws and regulations. Pursuant to its authority under the FDCA, the FDA has jurisdiction over medical devices, including in vitro diagnostics and, therefore, potentially our clinical laboratory tests.

Previous report

Pursuant to the FDCA and its implementing regulations, the FDA regulates the research, testing, manufacturing, safety, labeling, storage, recordkeeping, premarket clearance or approval, marketing and promotion, and sales and distribution of medical devices in the United States to ensure that medical products distributed domestically are safe and effective for their intended uses. Although the FDA has asserted that it has authority to regulate the development and use of LDTs, such as our and many other laboratories’ tests, as medical devices, it has generally exercised enforcement discretion and is currently not otherwise regulating most tests developed and performed within a single high complexity CLIA-certified laboratory. Pursuant to this enforcement discretion policy, FDA does not require laboratories that furnish LDTs to comply with the agency’s requirements for medical devices (e.g., establishment registration, device listing, quality systems regulations, premarket clearance or premarket approval, and post-market controls).

Previous report

We believe that our tests, as utilized in our clinical laboratory, are and would be considered LDTs and that as a result, the FDA does not require that we obtain regulatory clearances or approvals for our LDTs or their components pursuant to the FDA’s current policies and guidance.

Previous report

On September 29, 2023, FDA announced a proposed rule to amend its regulations to explicitly regulate laboratory developed tests (LDTs) as in vitro diagnostic tests in accordance with the agency’s regulatory authority over medical devices. The FDA finalized its rule on May 6, 2024 and announced that the agency would phase-out its LDT enforcement discretion policy in gradual stages over a total period of four years. LDTs that fall within targeted enforcement discretion policies may be exempt from some of these requirements. If the final rule, or a similar policy, were to take effect, our tests that are currently offered as LDTs could become subject to certain statutory and regulatory provisions that are applicable to medical devices, including but not limited to, medical device reporting and correction and removal reporting requirements, quality systems regulations, registration and listing requirements, and premarket review requirements. Under the final rule, laboratories offering “high-risk” tests that would be subject to premarket authorization application requirements or licensure under Section 351 of the Public Health Service Act, would need to ensure that the appropriate submission is received by the FDA before November 6, 2027. Laboratories offering “moderate-risk” or “low-risk” tests that would be subject to De Novo authorization or premarket notification submissions would need to ensure that the appropriate submission is received by the FDA before May 6, 2028. Other regulatory requirements would have been gradually phased in beginning on May 6, 2025.

Previous report

Failure to comply with applicable requirements under the relevant timeframes could cause us to lose the ability to perform our tests, experience disruptions to our business, or become subject to administrative or judicial enforcement actions, which in turn may have an adverse impact on our business, financial condition, and results of operations.

Previous report

Legal challenges have been filed in federal district court over the agency’s authority to regulate LDTs as medical devices. On March 31, 2025, the U.S. District Court for the Eastern District of Texas struck down the FDA’s final rule, concluding that it exceeds FDA’s statutory jurisdiction, authority, or limitations. The final rule was vacated and remanded to FDA for further consideration based on the opinion, with the court stating that “[t]here is no likelihood that FDA can justify its decision on remand, given that the final rule exceeds its authority under the FDCA.” The government did not file an appeal to the decision. Congress has also considered legislation to establish a new comprehensive regulatory framework that would provide oversight over LDTs. The Trump Administration may also reverse the final rule. However, in September 2025, the FDA issued the final rule that formally vacates the agency's May 2024 LDT final rule, following the March 2025 U.S. District Court for the Eastern District of Texas decision to vacate the rule.

Previous report

Even if the obligations that could be imposed by the final rule do not become applicable to our tests, Congress could take action to amend the law to change the current regulatory framework for in vitro diagnostics and LDTs to require premarket review of LDTs and other regulatory requirements. New requirements, whether imposed through legislation or administratively, could result in delay or additional expense in offering our tests and tests that we may develop in the future. Moreover, failure to comply with applicable requirements under the relevant timeframes could cause us to lose the ability to perform our tests, experience disruptions to our business, or become subject to administrative or judicial enforcement actions, which in turn may have an adverse impact on our business, financial condition, and results of operations.

Previous report

Our operations, therefore, may become subject to extensive regulation by the FDA in the United States. Government regulations specific to medical devices are wide ranging and govern, among other things:

Previous report

• test design, development, manufacture, and release;

Previous report

• laboratory and clinical testing, labeling, packaging, storage, and distribution;

Previous report

• product safety and efficacy;

Previous report

• premarketing clearance or approval;

Previous report

• service operations;

Previous report

• record keeping;

Previous report

• product marketing, promotion and advertising, sales, and distribution;

Previous report

• post-marketing surveillance, including reporting of deaths or serious injuries and recalls and correction and removals;

Previous report

• post-market approval studies; and

Previous report

• product import and export.

Previous report

The FDA and state authorities have broad enforcement powers. Our failure to comply with applicable regulatory requirements could result in enforcement action by any such agency, which may include any of the following sanctions:

Previous report

• adverse publicity, warning letters, untitled letters, it has come to our attention letters, fines, injunctions, consent decrees and civil penalties;

Previous report

• repair, replacement, refunds, recall or seizure of our diagnostic tests;

Previous report

• denial of our requests for regulatory clearance or premarket approval of new diagnostic tests or services, new intended uses, or modifications to existing diagnostic tests or services;

Previous report

• withdrawal of regulatory clearance or premarket approvals that have already been granted; or

Previous report

• criminal prosecution.

Previous report

As discussed above, we believe that our current line of diagnostic tests and their components are LDTs, which are subject to state licensing requirements and federal regulation by CMS under CLIA, which could cause us to be subject to additional FDA regulations discussed above.

Previous report

While we believe that we are currently in material compliance with applicable laws and regulations, it is possible that the FDA, or other regulatory agencies, would not agree with our determinations. If our products or services became subject to premarket submission and other FDA requirements, we would need to comply with the applicable regulations or face significant civil and criminal penalties. In addition, IVDs and CDx tests are widely considered to be Class III devices, and it is possible that in the future, we may develop tests that fall into this category. CDx tests in particular may require further administrative procedures in the IVD (PMA) submission process. Exposure to these additional regulatory requirements would also affect our business, financial condition and results of operations.

Previous report

Legislative or regulatory reforms may make it more difficult and costly for us to obtain regulatory clearance or approval or certification of any future diagnostic tests and to manufacture, market and distribute our diagnostic tests after clearance or approval is obtained.

Previous report

From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulatory approval, manufacture and marketing of regulated products or the reimbursement thereof. For example, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act introduced in Congress would codify into law the term “in vitro clinical test” in order to create a new medical product category separate from medical devices that would include products currently regulated as in vitro diagnostics as well as LDTs.

Previous report

In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our diagnostic tests. For example, on September 29, 2023, FDA announced a proposed rule to amend its regulations to explicitly regulate laboratory developed tests (LDTs) as in vitro diagnostic tests in accordance with the agency’s regulatory authority over medical devices. The FDA finalized its rule on May 6, 2024 and announced that the agency will phase-out its LDT enforcement discretion policy in gradual stages over a total period of four years. LDTs that fall within targeted enforcement discretion policies may be exempt from some of these requirements.

Previous report

Under the final rule, our tests that are currently offered as LDTs could become subject to certain statutory and regulatory provisions that are applicable to medical devices, including but not limited to, medical device reporting and correction and removal reporting requirements, quality systems regulations, registration and listing requirements, and premarket review requirements. Laboratories offering "high-risk" tests that would be subject to premarket authorization application requirements or licensure under Section 351 of the Public Health Service Act, would need to ensure that the appropriate submission is received by the FDA before November 6, 2027. Laboratories offering “moderate-risk” or “low-risk” tests that would be subject to De Novo authorization or premarket notification submissions would need to ensure that the appropriate submission is received by the FDA before May 6, 2028. Other regulatory requirements would have been gradually phased in beginning on May 6, 2025.

Previous report

Failure to comply with applicable requirements under the relevant timeframes could cause us to lose the ability to perform our tests, experience disruptions to our business, or become subject to administrative or judicial enforcement actions, which in turn may have an adverse impact on our business, financial condition, and results of operations.

Previous report

Legal challenges have been filed in federal district court over the agency’s authority to regulate LDTs as medical devices. On March 31, 2025, the U.S. District Court for the Eastern District of Texas struck down the FDA’s final rule, concluding that it exceeds FDA’s statutory jurisdiction, authority, or limitations. The final rule was vacated and remanded to FDA for further consideration based on the opinion, with the court stating that “[t]here is no likelihood that FDA can justify its decision on remand, given that the final rule exceeds its authority under the FDCA.” The government did not file an appeal to the decision. Congress has also considered legislation to establish a new comprehensive regulatory framework that would provide oversight over LDTs. The Trump Administration may also reverse the final rule. However, in September 2025, the FDA issued the final rule that formally vacates the agency's May 2024 LDT final rule, following the March 2025 U.S. District Court for the Eastern District of Texas decision to vacate the rule.