bioAffinity posts 270% revenue rise with Medicare coverage

SAN ANTONIO - bioAffinity Technologies, Inc. (NASDAQ:BIAF; BIAFW), a biotech firm specializing in noninvasive tests for early-stage lung cancer detection, has reported a substantial revenue increase for the year ended December 31, 2024. The company, currently valued at $4.1 million in market capitalization, announced a 270% growth in revenue to $9.4 million in 2024, up from $2.5 million the previous year. According to InvestingPro data, the stock has experienced significant volatility, declining 87% over the past year, though analysts anticipate continued sales growth.

The significant revenue growth is attributed to the increased demand for the company’s CyPath® Lung test, which saw orders rise by approximately 1,400% over the full year of 2023. This increase in demand is partly due to the Centers for Medicare and Medicaid Services (CMS) adding a unique CPT code for CyPath® Lung to its 2024 clinical laboratory fee schedule as of January 1, leading to the test being reimbursed by Medicare and private insurers. InvestingPro analysis shows the company maintains a gross profit margin of 35%, though it’s currently trading near its 52-week low.

The company also expanded its physician network, with the number of physician offices signed increasing by over 300% in 2024, which positions bioAffinity for potential continued growth in 2025. Additionally, CyPath® Lung was added to the U.S. Federal Supply Schedule in October 2024, allowing Veterans Health Administration and Military Health System facilities to access the test more easily.

A study published in the Journal of Health Economics and Outcomes Research highlighted the economic benefits of CyPath® Lung, suggesting significant cost savings in 2022 when used as a standard of care for Medicare patients with a positive lung cancer screening.

bioAffinity’s leadership team was strengthened with the appointment of J. Michael Edwards as Chief Financial Officer and William Bauta, PhD, as Chief Science Officer.

Despite the positive growth in 2024, the company anticipates a reduction in total revenue for 2025, projecting between $6 million to $8 million, including $1 to $2 million from CyPath lung tests sales. This anticipated decrease is due to the discontinuation of certain unprofitable pathology services, which is expected to be more than offset by cost reductions from lower labor and overhead costs at the company’s subsidiary laboratory.

The company’s net loss for the year ended December 31, 2024, was $9.0 million, or $0.75 per share, compared with a net loss of $7.9 million, or $0.91 per share, for the previous year. Cash and cash equivalents stood at $1.1 million as of December 31, 2024, down from $2.8 million at the end of 2023. However, bioAffinity raised $1.4 million through warrant exercises in February 2025.

This report is based on a press release statement from bioAffinity Technologies, Inc.

In other recent news, bioAffinity Technologies has announced a strategic plan to enhance the financial performance of its noninvasive lung cancer detection test, CyPath® Lung. The company anticipates approximately $4 million in annual cost savings by reducing its workforce and discontinuing certain services, while reallocating resources to boost CyPath® Lung sales. Additionally, bioAffinity Technologies has secured a patent in Australia for its CyPath® Lung test, expanding its intellectual property portfolio and market reach. The patent is expected to be granted automatically in three months and will remain in force until 2042, barring any opposition.

In a separate development, bioAffinity Technologies has been notified by Nasdaq about its failure to meet the minimum bid price requirement, with a 180-day period granted to regain compliance. The company is exploring options to address this issue and intends to take measures to meet Nasdaq’s listing requirements. Furthermore, the CEO of bioAffinity Technologies, Maria Zannes, has received a salary increase to $300,000, retroactive to November 1, 2024, as part of an amendment to her employment agreement. This adjustment aligns with the company’s commitment to recognizing leadership contributions. These developments highlight bioAffinity Technologies’ ongoing efforts to strengthen its market position and operational efficiency.

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