The following discussion and analysis of the Company's financial condition and results of operations should be read in conjunction with (i) the Company's unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and (ii) the Company's audited consolidated financial statements and related notes and management’s discussion and analysis of financial condition and results of operations included in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission on March 9, 2026. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to the Company's plans and strategy for its business and impact and potential impacts on its business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including, without limitation, those factors set forth in the “Risk Factors” section of the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and the “Risk Factors” section of subsequent Quarterly Reports on Form 10-Q, the Company's actual results or timing of certain events could differ materially from the results or timing described in, or implied by, these forward-looking statements. 23 Business Overview The Company's business consists of the development, manufacture, marketing, sale and distribution of simple, easy to use diagnostic products and specimen collection devices using its proprietary technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types. The Company's diagnostic products include tests for diseases including HIV, Hepatitis C, Syphilis, Sickle Cell and COVID-19 that are performed on a rapid basis at the point of care. These products are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations, and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities. The Company's HIV and COVID-19 products are also sold in a consumer-friendly format in the over-the-counter ("OTC") market in the U.S. and, in the case of the HIV and HCV products, as a self-test to individuals in a number of other countries, including, for the HIV products, as an oral swab in-home test for HIV-1 and HIV-2 in Europe, and for the HCV products, as an OTC test. The Company's business also includes sample management solutions and services that are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers. The revenues from sample management solutions are derived from product sales to commercial customers and sales into the academic and research markets. Customers span the disease risk management, diagnostics, pharmaceutical, biotech, and companion animal market segments. The Company has also developed collection devices for the emerging microbiome market, which focuses on studying microbiomes and their effect on human and animal health. The Company also has a urine collection device which allows for the volumetric collection of first void urine. Initial sales of this product for research use only are occurring primarily through distributors and collaborations in the liquid biopsy and sexually transmitted disease markets. In December 2025, the Company submitted a 510(k) to the FDA for clearance of its Colli-Pee® at-home urine collection device for sexually transmitted infections, which was approved in June 2026. Risk Assessment Testing During the third quarter of 2024, the Company announced the discontinuance of sales of its risk assessment product line, which was completed in the second quarter of 2025. Sales of its risk assessment products did not contribute to revenues during the six months ended June 30, 2026. Sales of its risk assessment products contributed $0.4 million to revenues during the three months ended June 30, 2025 and $1.9 million for the six months ended June 30, 2025. During the first quarter of 2025, the Company sold certain assets that made up the risk assessment product line including certain intellectual property, contracts, permits, and equipment. Recent Developments In June 2026, the Company received clearance from the FDA of its Colli-Pee™•Dx Urine Collection Kit for use on Roche's tests for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) and to run on Roche’s cobas® 5800, 6800, and 8800 molecular diagnostic systems. The Colli-Pee™•Dx Urine Collection Kit will be sold by the Company's subsidiary DNA Genotek Inc. and supports at-home self-collection of first-void urine, enabling convenient sample collection at-home or in any private setting for both male and female patients. In July 2026, the Company received Emergency Use Authorization ("EUA") from the FDA for its second generation OraQuick™ Ebola Rapid Antigen Test for use with whole blood in live patients, as well as cadaveric oral fluid from individuals suspected to have had Ebola disease at the time of death. The test can detect all four Ebola viruses currently known to cause disease in humans: Bundibugyo, Zaire, Sudan, and Taï Forest. The OraQuick® Ebola Rapid Antigen Test originally received De Novo marketing authorization from the FDA in 2019, making it the first and only rapid antigen test to receive full authorization for the detection of Ebola virus. The second-generation test authorized by the FDA has increased sensitivity, new chemistry, and a more automated manufacturing process. It was developed in cooperation with the Biomedical Advanced Research and Development Authority (BARDA) under a contract granted in 2022. The current Ebola epidemic, centered in the Democratic Republic of the Congo with cases extending into neighboring Uganda, has already resulted in hundreds of deaths and prompted the World Health Organization to declare a global public health emergency. The Company is ramping up production of the OraQuick™ Ebola 2.0 Rapid Antigen Test to meet potential demand and expand access to a proven, reliable test. In December 2025, the Company submitted a 510(k) to the FDA for clearance of its rapid molecular self-test for CT/NG. Following constructive interactions with the FDA, the Company is updating its submission plan for the CT/NG test on the Sherlock platform to incorporate feedback received from the agency. As part of this process, in July 2026, the Company elected to withdraw its current submission and plans to pursue a future submission. The clinical studies that were 24 performed demonstrated strong performance compared with centralized laboratory molecular diagnostic methods, and the Company remains encouraged by the product’s performance and its potential to serve an important public health need. 25 Results of Operations (all dollar amounts in tables are presented in thousands) For the three months ended June 30, 2026 compared to June 30, 2025. CONSOLIDATED NET REVENUES The table below shows total consolidated net revenues for the three months ended June 30, 2026 and 2025: For the Three Months Ended June 30, Dollars % Change Percentage of Total Net Revenues 2026 2025 2026 2025 Diagnostics (1) $ 19,351 $ 19,222 1 % 63 % 62 % Sample Management Solutions (2) 9,875 9,855 — 32 32 Other products and services (3) 498 324 54 2 1 Risk Assessment Testing (4) — 446 (100) — 1 Net product and services revenues 29,724 29,847 — 97 96 Non-product and services revenues (5) 915 1,395 (34) 3 4 Net revenues $ 30,639 $ 31,242 (2) % 100 % 100 % (1)Includes HIV, HCV, Syphilis, SickleSCAN® and SureQuick® product revenues. (2)Includes Genomics, Microbiome, and Colli-Pee® product revenues. (3)Includes COVID-19 Sample Management Solutions and COVID-19 Diagnostics product revenues. (4)Includes substance abuse testing product revenues. (5)Includes funded research and development contracts, royalty income and grant revenues. Product and Services Revenues Consolidated net revenues decreased 2% to $30.6 million for the three months ended June 30, 2026 from $31.2 million for the three months ended June 30, 2025. Sales of the Company's Diagnostics products increased 1% to $19.4 million for the three months ended June 30, 2026 from $19.2 million for the three months ended June 30, 2025. This increase was primarily driven by higher syphilis sales resulting from new customers in the women's health market and the inclusion of SickleSCAN® revenues, a new revenue stream acquired through the BioMedomics, Inc. acquisition completed in November 2025. These increases were partially offset by lower HCV revenues due to the expiration and non-renewal of a large customer's HCV testing program, as well as reduced funding associated with other programs. The increase was further offset by lower domestic HIV revenues attributable to lower purchases under the Together Take Me Home Program. Sample Management Solutions revenues remained largely flat at $9.9 million for the three months ended June 30, 2026 and 2025. Risk Assessment Testing revenues are $0 in 2026 as the product line was discontinued and wound down in early 2025. Non-Product and Services Revenues Non-product and services revenues decreased 34% to $0.9 million for the three months ended June 30, 2026 from $1.4 million for the three months ended June 30, 2025 primarily due to the completion of various funded R&D contracts. CONSOLIDATED OPERATING RESULTS Consolidated gross profit margin increased to 43.5% for the three months ended June 30, 2026 compared to 42.1% for the three months ended June 30, 2025. The drivers of the margin increase are attributable to better absorption of fixed overhead costs due to operational efficiencies, partially offset by a negative product mix and lower non-product revenues which contribute 100% to gross margin. Consolidated operating income for the three months ended June 30, 2026 was $5.4 million compared to an operating loss of $18.0 million for the three months ended June 30, 2025. 26 Research and development expenses decreased 17% to $9.4 million for the three months ended June 30, 2026 from $11.4 million for the three months ended June 30, 2025 primarily due to lower clinical trial costs associated with the Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) device. Sales and marketing expenses increased 4% to $6.6 million for the three months ended June 30, 2026 from $6.4 million for the three months ended June 30, 2025. General and administrative expenses increased 14% to $14.4 million for the three months ended June 30, 2026 from $12.7 million for the three months ended June 30, 2025 largely due to an increase in legal fees and in professional services related to the proxy statement and related stockholder activism costs. All of the above contributed to the Company's operating income of $5.4 million for the three months ended June 30, 2026, which included non-cash charges of $2.4 million for depreciation and amortization and $2.3 million for stock-based compensation, and $22.6 million in non-cash income reflected in the change in the estimated fair value of acquisition-related contingent consideration. The Company's operating loss of $18.0 million for the three months ended June 30, 2025 included non-cash charges of $3.2 million for stock-based compensation, $2.5 million for depreciation and amortization, and $0.7 million for the change in the estimated fair value of acquisition-related contingent consideration. OTHER INCOME Other income for the three months ended June 30, 2026 was $1.4 million compared to $1.1 million for the three months ended June 30, 2025. The increase in other income is due to lower interest income offset by lower foreign currency losses. CONSOLIDATED INCOME TAXES The Company continues to believe the full valuation allowance established against its total U.S. and U.K. deferred tax asset is appropriate as the facts and circumstances necessitating the allowance have not changed. For the three months ended June 30, 2026 and 2025, the Company recorded income tax expense of $0.1 million and $2.0 million, respectively. During the three months ended June 30, 2026 and 2025, the Company had an effective tax rate of 0.8% and (11.8)%, respectively. The increase in the Company's tax rate was primarily due to the recording of a uncertain tax position in 2025 and projected break-even results in foreign operations in 2026 versus projected losses in 2025. Results of Operations For the six months ended June 30, 2026 compared to June 30, 2025. CONSOLIDATED NET REVENUES The table below shows an outline of total consolidated net revenues for the six months ended June 30, 2026 and 2025: For the Six Months Ended June 30, Dollars % Change Percentage of Total Net Revenues 2026 2025 2026 2025 Diagnostics (1) $ 36,217 $ 36,911 (2) % 62 % 60 % Sample Management Solutions (2) 18,933 18,965 — 32 31 Other products and services 931 617 51 2 1 COVID-19 Diagnostics 19 485 (96) — 1 Risk Assessment Testing (3) — 1,866 (100) — 3 Net product and services revenues 56,100 58,844 (5) 96 96 Non-product and services revenues (4) 2,464 2,329 6 4 4 Net revenues $ 58,564 $ 61,173 (4) % 100 % 100 % (1)Includes HIV, HCV, Syphilis, SickleSCAN® and SureQuick® product revenues. (2)Includes Genomics, Microbiome, and Colli-Pee® product revenues. (3)Includes substance abuse testing product revenues. (4)Includes funded research and development contracts, royalty income, and grant revenues. 27 Product and Services Revenues Consolidated net revenues decreased 4% to $58.6 million for the six months ended June 30, 2026 from $61.2 million for the six months ended June 30, 2025. Sales of the Company's Diagnostics products decreased 2% to $36.2 million for the six months ended June 30, 2026 from $36.9 million for the six months ended June 30, 2025. This decline is primarily attributable to lower international HCV revenues driven by reduced reimbursement subsidies in the Asian market and a large order shipped into Africa in the second quarter of 2025 that did not recur. Domestic HCV revenues also declined as a result of a large customer's HCV testing programs ending and not being renewed, as well as reduced funding associated with other programs. In addition, domestic HIV revenues decreased due to lower purchases under the Together Take Me Home program partially offset by higher international revenues associated with timing of customer orders. These decreases were partially offset by higher syphilis sales driven by new customers in the women's health market and the inclusion of SickleSCAN® revenues, a new revenue stream acquired through the BioMedomics, Inc. acquisition completed in November 2025. Sample Management Solutions revenues remained largely flat at $18.9 million for the six months ended June 30, 2026 and 2025. COVID-19 Diagnostics revenues decreased 96% to $19.0 thousand for the six months ended June 30, 2026 from $485.0 thousand for the six months ended June 30, 2025 due to lower overall demand for COVID-19 testing. Risk Assessment testing revenues decreased to zero for the six months ended June 30, 2026 from $1.9 million for the six months ended June 30, 2025. The Company discontinued this line of business at the end of 2024 and the business wound down in early 2025. Non-Product and Services Revenues Non-product and services revenues increased 6% to $2.5 million for the six months ended June 30, 2026 from $2.3 million for the six months ended June 30, 2025 primarily due to an increase in funded R&D under certain BARDA contracts. CONSOLIDATED OPERATING RESULTS Consolidated gross profit margin increased to 42.9% for the six months ended June 30, 2026 from 41.6% for the six months ended June 30, 2025. The largest driver of the margin improvement is better absorption of fixed overhead costs due to operational efficiencies partially offset by higher scrap expense. Consolidated operating loss for the six months ended June 30, 2026 was $17.8 million, compared to a $35.8 million operating loss reported for the six months ended June 30, 2025. Results for the six months ended June 30, 2026 benefited from a $22.5 million change in the estimated fair value of acquisition-related contingent consideration but were negatively impacted by the decrease in revenues and by higher operating expenses. Research and development expenses increased 10% to $23.1 million for the six months ended June 30, 2026 from $21.0 million for the six months ended June 30, 2025 largely due to higher spend incurred for clinical trials for the CT/NG and Colli-Pee® devices. Sales and marketing expenses remained largely flat at $13.4 million and $13.2 million for the six months ended June 30, 2026 and 2025, respectively. General and administrative expenses increased 8% to $29.0 million for the six months ended June 30, 2026 from $26.8 million for the six months ended June 30, 2025, largely due to higher professional, consulting, and legal fees associated with the proxy statement, including stockholder activism costs. All of the above contributed to the Company's operating loss of $17.8 million for the six months ended June 30, 2026, which included non-cash income of $22.5 million reflected in the change in the estimated fair value of acquisition-related contingent consideration, and non-cash charges of $5.1 million for stock-based compensation, and $4.7 million for depreciation and amortization. The Company's operating loss of $35.8 million for the six months ended June 30, 2025 included a non-cash charge of $5.9 million for stock-based compensation, $5.3 million for depreciation and amortization, and $1.2 million for the change in the estimated fair value of acquisition-related contingent consideration. 28 CONSOLIDATED OTHER INCOME Other income remained largely flat at $2.9 million for the six months ended June 30, 2026 and 2025. CONSOLIDATED INCOME TAXES The Company continues to believe the full valuation allowance established against its total U.S. deferred tax asset is appropriate as the facts and circumstances necessitating the allowance have not changed. The Company has not achieved U.S. cumulative pre-tax earnings based on a rolling three year window as the Company has not achieved a level of sustained profitability that would, in its judgment, support the release of the valuation allowance. For the six months ended June 30, 2026 and 2025, the Company recorded income tax benefit and expense of $0.4 million and $1.5 million, respectively. During the six months ended June 30, 2026 and 2025, the Company had an effective tax rate of 2.5% and (4.7)%, respectively. The increase in the Company's tax rate was primarily due to the recording of a uncertain tax position in 2025 and projected break-even results in foreign operations in 2026 versus projected losses in 2025. Liquidity and Capital Resources June 30, 2026 December 31, 2025 (in thousands) Cash and cash equivalents $ 160,582 $ 199,278 Working capital 197,818 222,113 The Company's cash and cash equivalents decreased to $160.6 million at June 30, 2026 from $199.3 million at December 31, 2025. The Company has $84.6 million, or 53%, of its $160.6 million of cash and cash equivalents held by DNAG, the Company's Canadian subsidiary. The Company's working capital decreased to $197.8 million at June 30, 2026 from $222.1 million at December 31, 2025. Working capital is primarily a function of sales, purchase volumes, inventory requirements, and vendor payment terms. Analysis of the Company's Cash Flows Operating Activities During the six months ended June 30, 2026, net cash used in operating activities was $23.8 million. Cash flows from operations can be significantly impacted by factors such as timing of receipts from customers, inventory purchases, and payments to vendors. The Company's net loss of $16.1 million included non-cash charges of a change in the estimated fair value of acquisition-related contingent consideration of $22.5 million, stock-based compensation expense of $5.1 million, depreciation and amortization expense of $4.7 million, a loss on equity investment of $1.6 million, and other non-cash charges aggregating to $0.2 million. Changes in the Company's working capital accounts contributed to cash and included an increase in accrued expenses and other liabilities of $2.9 million largely associated with higher compensation-related accruals, a decrease in prepaid expenses and other assets of $2.5 million resulting from lower deposits paid, an increase of $1.3 million in accounts payable associated with the timing of spend on consulting services and inventory purchases, and an overall decrease in inventory balances of $0.9 million due to an increase in inventory reserves associated with expired inventory and lower COVID-19 inventory levels due to decreased demand. These contributions to cash were offset by an increase in accounts receivable of $3.7 million due to timing of shipments and invoicing and a decrease in deferred revenue of $0.6 million as work on grant projects is completed and earned. Investing Activities Net cash used in investing activities was $3.3 million for the six months ended June 30, 2026, for purchases of property and equipment. Financing Activities 29 Net cash used in financing activities was $8.5 million for the six months ended June 30, 2026, which was largely comprised of $7.0 million to repurchase common stock pursuant to the Company's stock repurchase plan and $1.5 million used for the repurchase of common stock to satisfy withholding taxes related to the vesting of restricted stock awarded to the Company's employees. Resources The Company's contractual obligations are included in Note 12 of its consolidated financial statements. The Company expects existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements over the next twelve months. The Company's cash requirements, however, may vary materially from those now planned due to many factors, including, but not limited to, the scope and timing of future strategic acquisitions, the progress of its research and development programs, the scope and results of clinical testing, the cost of any future litigation, the magnitude of capital expenditures, changes in existing and potential relationships with business partners, the timing and cost of obtaining regulatory approvals, the timing and cost of future stock purchases, the costs involved in obtaining and enforcing patents, proprietary rights and any necessary licenses, the cost and timing of expansion of sales and marketing activities, market acceptance of new products, competing technological and market developments, the impact of the current economic environment and other factors. Critical Accounting Policies and Estimates A more detailed review of the Company's critical accounting policies is contained in its Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC. No material changes have been made to such critical accounting policies during the six months ended June 30, 2026.