▸ Although publicly traded securities are subject to price and volume fluctuations, it is likely that our common stock will experience these fluctuations to a greater degree than the securities of more established and better capitalized organizations.· ● 1 ▸ Failure to establish and maintain adequate finance infrastructure and accounting systems and controls could impair our ability to comply with the financial reporting and internal controls requirements for publicly traded companies.· ● 1 ▸ Failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a delisting of our common stock.· ● 1 ▸ Increased competition from, and technological advances by, our competitors could negatively affect our operating results.· ● 1 ▸ The trading price of our common stock is highly volatile, and purchasers of our common stock could incur substantial losses.· ● 1 ▸ Our former parent company may sell our shares to raise capital to finance its operations.● · 1 ▸ Sales or other issuances of additional equity securities by us could result in the dilution of the interests of our stockholders.● · 1 ▸ Slower than anticipated rates of patient recruitment and enrollment, or failing to reach the targeted number of patients due to competition for patients from other trials;● · 1 ▸ The commercial success of our diagnostic tests depends on the availability and sufficiency of third-party payer coverage and reimbursement, which may be limited or unavailable.● · 1 ▸ We are subject to state laws in California that require gender and diversity quotas for boards of directors of public companies headquartered in California.● · 1 ▸ We will also need to obtain FDA and other regulatory approvals for any IVDs that we may develop, or for any currently marketed products the FDA determines are IVDs instead of LDTs, in order to market those IVD tests.● · 1 ▸ A diagnostic test that is cleared or approved for marketing may be subject to restrictions on use; and● ● 2 ▸ Any of the foregoing factors as well as other unforeseen events could delay or prevent commercialization of our current or future diagnostic tests and adversely affect our business, financial condition and results of operations.● ● 2 ▸ Because of certain Medicare billing policies, we may not receive complete reimbursement for tests provided to Medicare patients.● ● 2 ▸ Because we do not pay dividends, our stock may not be a suitable investment for anyone who needs to earn dividend income.● ● 2 ▸ Changes in healthcare laws and policies may have a material adverse effect on our financial condition, results of operations and cash flows.● ● 2 ▸ Changes to the patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our diagnostic tests.● ● 2 ▸ Failure of our internal control over financial reporting could harm our business and financial results.● ● 2 ▸ Failure to adequately protect, or disputes relating to, trademarks or patents, could harm our business.● ● 2 ▸ If our laboratory facilities become damaged or inoperable, or we are required to vacate any facility, our ability to provide services and pursue our research and development and commercialization efforts may be jeopardized.● ● 2 ▸ If we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our diagnostic tests.● ● 2 ▸ If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected, and our business would be harmed.● ● 2 ▸ If we fail to enter into and maintain successful strategic alliances for diagnostic tests that we elect to co-develop, co-market, or out-license, we may have to reduce or delay our diagnostic test development or increase our expenditures.● ● 2 ▸ Inability or unwillingness of medical investigators to follow our clinical protocols.● ● 2 ▸ Inability to replicate in large controlled studies safety and efficacy data obtained from a limited number of patients in uncontrolled trials; and● ● 2 ▸ Long payment cycles of Medicare, Medicaid and other third-party payers, or other payment delays, could hurt our cash flows and increase our need for working capital.● ● 2 ▸ group Negative or inconclusive results from clinical trials;● ● 2 ▸ Obtaining and maintaining patent protection depends on compliance with various procedures and other requirements, and our patent protection could be reduced or eliminated in case of non-compliance with these requirements.● ● 2 ▸ Other companies or organizations may challenge our patent rights or may assert patent rights that prevent us from developing and commercializing our diagnostic tests.● ● 2 ▸ Our business and operations could suffer in the event of system failures.● ● 2 ▸ Our business could be adversely affected if we lose the services of the key personnel upon whom we depend.● ● 2 ▸ Our business could be adversely impacted by inflation.● ● 2 ▸ Our revenues in the near term will depend on our ability to commercialize a small number of diagnostic tests.● ● 2 ▸ Patent terms may be inadequate to protect our competitive position on our diagnostic tests for an adequate amount of time.● ● 2 ▸ Private health insurance company policies may deny coverage or limit reimbursement for the performance of our diagnostic tests.● ● 2 rw ▸ group Risks Related to Intellectual Property● ● 2 ▸ group Risks Related to Our Business Operations● ● 2 ▸ group Risks Related to Our Capital Resources● ● 2 ▸ group Risks Related to Our Common Stock● ● 2 ▸ group Risks Related to Our Industry● ● 2 ▸ Sales of our diagnostic tests could be adversely impacted by the reluctance of physicians to adopt the use of our tests and by the availability of competing diagnostic tests.● ● 2 ▸ Securities analysts may not initiate coverage or continue to cover our common stock, and this may have a negative impact on the market price of our shares.● ● 2 ▸ Security breaches and other disruptions could compromise our information and expose us to liability, and could cause our business and reputation to suffer.● ● 2 ▸ Tariff policies and potential countermeasures could increase our costs and disrupt our global supply chain, which could negatively impact the results of our operations.● ● 2 ▸ The FDA can withdraw approval of an FDA regulated product if problems arise.● ● 2 ▸ The IVDs cannot be sold until the CMS or the FDA, and corresponding foreign regulatory authorities approve or authorize the IVDs for medical use;● ● 2 ▸ The research and development work we are doing is costly, time consuming, and uncertain as to its results.● ● 2 ▸ There is a limited number of manufacturers of molecular diagnostic testing equipment and related chemical reagents necessary for the provision of our diagnostic tests.● ● 2 ▸ We are a “smaller reporting company” under the SEC’s disclosure rules and have elected to comply with the reduced disclosure requirements applicable to smaller reporting companies.● ● 2 ▸ We are subject to laws and regulations governing corruption, which may require us to develop, maintain, and implement costly compliance programs.● ● 2 ▸ We have incurred operating losses since inception, and we do not know if we will attain profitability.● ● 2 ▸ We have limited capital, marketing, sales, and regulatory compliance resources for the commercialization of our diagnostic tests.● ● 2 ▸ We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful.● ● 2 ▸ We may become subject to litigation, which could harm our stock price, business, results of operations and financial condition.● ● 2 rw ▸ We may face technology transfer challenges and expenses in adding new tests to our portfolio and in expanding our reach into new geographical areas on new instrument platforms.● ● 2 ▸ We may incur significant cash payment and common stock issuance obligations under our agreements arising from our investments in IGI and Chronix.● ● 2 rw ▸ We may not be able to enforce our intellectual property rights throughout the world.● ● 2 ▸ We may not be able to obtain patent protection for our diagnostic tests if our pending U.S. patent applications are found to be directed to unpatentable subject matter.● ● 2 ▸ We may undertake strategic acquisitions in the future, and difficulties integrating such acquisitions could damage our ability to achieve or sustain profitability.● ● 2 ▸ We will be required to comply with federal and state laws governing the privacy of health information, and any failure to comply with these laws could result in material criminal and civil penalties.● ● 2 ▸ You may experience dilution of your ownership interests if we issue additional shares of common stock or preferred stock.● ● 2 
