Lung Cancer Detection Test Drives 270% Revenue Increase
BioAffinity Technologies, Inc. (NASDAQ; BIAFW), a biotechnology company focused on early-stage lung cancer detection through noninvasive testing, has achieved remarkable financial results for the fiscal year 2024. With a modest market capitalization of $4.1 million, the company reported an impressive 270% revenue surge to $9.4 million, compared to $2.5 million in the previous year. This significant growth comes despite the stock experiencing considerable volatility, declining 87% over the past twelve months according to InvestingPro data.
CyPath® Lung Test Sees Explosive Demand
The company’s flagship product, CyPath® Lung, has been the primary catalyst for this extraordinary revenue growth. Orders for this innovative cancer detection test increased by approximately 1,400% compared to 2023 figures. This dramatic uptick in demand can be largely attributed to a critical regulatory development: the Centers for Medicare and Medicaid Services (CMS) implemented a unique CPT code for CyPath® Lung in its 2024 clinical laboratory fee schedule effective January 1. This development has enabled Medicare and private insurers to provide reimbursement for the test, significantly expanding its accessibility and adoption.
Expanding Healthcare Network and Government Access
BioAffinity Technologies has successfully broadened its physician network, with the number of partnered physician offices increasing by over 300% during 2024. This expansion positions the company favorably for potential continued growth into 2025. Additionally, the company achieved another milestone in October 2024 when CyPath® Lung was added to the U.S. Federal Supply Schedule, providing Veterans Health Administration and Military Health System facilities easier access to this innovative diagnostic tool.
Economic Benefits Validated by Research
The economic advantages of CyPath® Lung were highlighted in a study published in the Journal of Health Economics and Outcomes Research. The research demonstrated significant potential cost savings when the test is implemented as a standard of care for Medicare patients who receive positive lung cancer screening results. This economic validation further strengthens the value proposition of BioAffinity’s technology in the healthcare marketplace.
Leadership Strengthening Amid Growth
To support its rapid expansion, BioAffinity Technologies bolstered its leadership team by appointing J. Michael Edwards as Chief Financial Officer and William Bauta, PhD, as Chief Science Officer. These strategic additions to the executive team are designed to guide the company through its next phase of development and commercialization.
Financial Performance and Future Outlook
Despite the remarkable revenue growth in 2024, BioAffinity Technologies anticipates a reduction in total revenue for 2025, projecting between $6 million to $8 million, including $1 to $2 million specifically from CyPath lung tests sales. This expected decrease stems from the strategic decision to discontinue certain unprofitable pathology services. However, the company expects this revenue reduction to be more than offset by cost reductions resulting from lower labor and overhead expenses at its subsidiary laboratory.
For the fiscal year ended December 31, 2024, the company reported a net loss of $9.0 million ($0.75 per share), compared to a net loss of $7.9 million ($0.91 per share) in the previous year. Cash and cash equivalents decreased to $1.1 million by the end of 2024, down from $2.8 million at the close of 2023. Nevertheless, BioAffinity raised an additional $1.4 million through warrant exercises in February 2025, bolstering its financial position.
Strategic Initiatives and Operational Efficiency
BioAffinity Technologies has recently announced a comprehensive strategic plan aimed at enhancing the financial performance of CyPath® Lung. The company anticipates approximately $4 million in annual cost savings through workforce reductions and discontinuation of certain services, while simultaneously reallocating resources to boost sales of its core product.
Intellectual Property Expansion and Challenges
The company has secured a patent in Australia for its CyPath® Lung test, expanding its intellectual property portfolio and potential market reach. This patent is expected to be granted automatically within three months and will remain valid until 2042, barring any opposition. This international patent protection represents an important step in BioAffinity’s global commercialization strategy.
Despite these positive developments, BioAffinity Technologies faces challenges on the compliance front. The company has received notification from Nasdaq regarding its failure to meet the minimum bid price requirement, though it has been granted a 180-day period to regain compliance. The management team is currently exploring options to address this issue and intends to implement measures to meet Nasdaq’s listing requirements.
In recognition of leadership contributions during this period of transformation, CEO Maria Zannes received a salary increase to $300,000, retroactive to November 1, 2024, as part of an amendment to her employment agreement.
Discover the latest GovHealth news updates with a single click. Follow DistilINFO GovHealth and stay ahead with updates. Join our community today!
