bioAffinity Technologies Set for Continued Expansion in 2025

Rhea-AI Summary

bioAffinity Technologies (BIAF) reports strong growth and expansion plans for 2025, driven by its CyPath® Lung cancer detection test. The company's subsidiary, Precision Pathology Laboratory Services, expects $9.4 million in 2024 revenues, representing over 20% growth compared to 2023 after its acquisition in September 2023.

CyPath® Lung sales showed a remarkable 1,750% increase through November 30 compared to the previous year. Key achievements in 2024 include securing reimbursement, expanding the sales team, gaining access to federal healthcare systems, and operational streamlining. The company anticipates continued growth in 2025 through expanded national market presence and inclusion in the U.S. Federal Supply Schedule, serving the Veterans Health Administration and Military Health System.

Positive

• Projected revenue of $9.4 million for 2024, representing 20% growth
• 1,750% increase in CyPath® Lung sales through November 2024
• Secured reimbursement for CyPath® Lung test
• Gained access to federal healthcare system through U.S. Federal Supply Schedule

Negative

• None.

Insights

Financial Analyst

The financial outlook for bioAffinity Technologies appears promising with significant growth metrics. PPLS is projected to achieve $9.4 million in 2024 revenues, representing over 20% growth from 2023 (post-PPLS acquisition). The standout performer is CyPath® Lung, showing an impressive 1,750% increase in sales through November compared to last year. The company has strategically positioned itself for sustained growth in 2025 through key developments including reimbursement approval, sales team expansion and access to federal healthcare systems.

The inclusion in the U.S. Federal Supply Schedule is particularly significant as it opens up substantial market opportunities within the VHA and Military Health System. For a small-cap company ($15.6M market cap), these achievements and growth trajectory suggest strong potential for value creation, though investors should note that maintaining such high growth rates may become challenging as the revenue base expands.

Medical Research Analyst

CyPath® Lung's positioning as a noninvasive early detection tool for lung cancer represents a significant advancement in diagnostic technology. The test's flexibility to be used either standalone or complementary to other diagnostic tools enhances its clinical utility and market potential. The 1,750% sales growth indicates strong clinical adoption and validation of the technology. The integration into the federal healthcare system through the VHA and Military Health System provides access to a large patient population at high risk for lung cancer, potentially accelerating adoption rates.

The test addresses a critical need in lung cancer diagnostics, where early detection significantly improves survival rates. The noninvasive nature of the test could lead to higher screening compliance rates compared to more invasive alternatives, potentially expanding the addressable market.

Noninvasive CyPath^® Lung test for lung cancer contributes to growing revenues

SAN ANTONIO--(BUSINESS WIRE)-- bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer, today reported that the successful execution of its pilot marketing program and steady growth in sales of the CyPath® Lung test for early detection of lung cancers have set the stage for expansion and record revenues in 2025.

The Company’s wholly owned subsidiary Precision Pathology Laboratory Services (PPLS) is on track to report upwards of $9.4 million in 2024 revenues, more than 20% growth in annualized revenues over 2023 after accounting for the acquisition of PPLS in September 2023. The increase in revenues reflects a 1,750% increase in sales of CyPath® Lung through Nov. 30, compared to the same period last year.

“The seamless integration of Precision Pathology into bioAffinity Technologies since the acquisition is going to result in a record revenue year for the laboratory, due in part to the broader market adoption of CyPath® Lung,” bioAffinity President and CEO Maria Zannes said. “We count many successes in 2024, including obtaining reimbursement for CyPath® Lung, expanding our sales team, obtaining access to the federal healthcare system, and streamlining operations. We have the capability and the experience to expand operations exponentially to meet the growing demand for CyPath® Lung as we move to the national stage in 2025.”

CyPath® Lung revenues are expected to continue growing in 2025 with expanded sales into strategic national markets and inclusion in the U.S. Federal Supply Schedule. This key procurement system provides streamlined access to state-of-the-art healthcare solutions for the Veterans Health Administration (VHA) and the Military Health System. CyPath^® Lung fills an important need for a noninvasive test to improve the early detection of lung cancer in patients at high risk. CyPath^® Lung can be used alone or in combination with other diagnostic tools, positioning it as a cornerstone of next-generation lung cancer care.

About CyPath^® Lung

CyPath^® Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath^® Lung incorporates a fluorescent porphyrin, meso-tetra (4-carboxyphenyl) porphyrin (TCPP), that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath^® Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

About bioAffinity Technologies, Inc.

bioAffinity Technologies, Inc. (Nasdaq: BIAF) addresses the need for noninvasive diagnosis of early-stage cancer and diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath^® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit www.bioaffinitytech.com and follow us on LinkedIn, Facebook and X.

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding expansion and record revenues in 2025, the expected 2024 revenues from PPLS, growing demand for CyPath® Lung as the Company moves to the national stage in 2025, and CyPath® Lung revenues being expected to continue growing in 2025 with expanded sales into strategic national markets and inclusion in the U.S. Federal Supply Schedule. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of the Company to increase sales through the U.S. Federal Supply Schedule and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241212813114/en/

bioAffinity Technologies

Julie Anne Overton

Director of Communications

jao@bioaffinitytech.com



Investor Relations

Dave Gentry

RedChip Companies Inc.

1-800-RED-CHIP (733-2447) or 407-491-4498

BIAF@redchip.com

Source: bioAffinity Technologies, Inc.

FAQ

What is BIAF's projected revenue for 2024?

BIAF's subsidiary Precision Pathology Laboratory Services is projected to generate $9.4 million in revenue for 2024, representing over 20% growth compared to 2023.

How much did CyPath® Lung sales increase for BIAF in 2024?

CyPath® Lung sales increased by 1,750% through November 30, 2024, compared to the same period in 2023.

What major achievements did BIAF accomplish in 2024?

In 2024, BIAF secured reimbursement for CyPath® Lung, expanded its sales team, gained access to the federal healthcare system, and streamlined operations.

How will BIAF expand CyPath® Lung distribution in 2025?

BIAF plans to expand CyPath® Lung distribution through strategic national markets and inclusion in the U.S. Federal Supply Schedule, serving the Veterans Health Administration and Military Health System.