bioAffinity Technologies Reports Accelerating Growth of Physician Practices Ordering CyPath® Lung Tests

Rhea-AI Summary

BioAffinity Technologies (Nasdaq: BIAF; BIAFW) has reported a significant 139% growth in the number of pulmonology practices offering its noninvasive CyPath® Lung test for early-stage lung cancer detection since January 1, 2024. Sales outpaced Q1 2024 targets, leading to expansion beyond Texas to eight additional states. The company increased its 2023 sales forecast by 35% in May. This growth is attributed to positive physician-to-physician word of mouth and effective marketing strategies. CyPath® Lung's high sensitivity, specificity, and accuracy have been well-received by the medical community. The lung cancer diagnostics market is projected to reach $4.7 billion by 2030.

Positive

• 139% growth in the number of pulmonology practices offering CyPath® Lung since Jan 1, 2024.
• CyPath® Lung sales exceeded Q1 2024 targets.
• Expansion of CyPath® Lung to eight additional states beyond Texas.
• Increased 2023 sales forecast by 35% in May.
• Physician-to-physician word of mouth driving earlier-than-expected expansion.
• High sensitivity, specificity, and accuracy of CyPath® Lung recognized by physicians.
• Projected lung cancer diagnostics market size of $4.7 billion by 2030.

Negative

• None.

Insights

Financial Analyst

The reported 139% growth in the number of pulmonology practices onboarding CyPath® Lung is an important indicator of accelerating market adoption. This statistic suggests that the company’s product is gaining significant traction among medical professionals, which is important for sustained revenue growth. The expansion into eight additional states ahead of schedule indicates robust demand and effective marketing strategies. Moreover, the 35% increase in sales forecasts is a positive signal to investors, reflecting management’s confidence and the product’s potential to capture a larger market share in the lung cancer diagnostics market, projected to reach $4.7 billion by 2030. Such growth prospects could enhance shareholder value, assuming the company can maintain this momentum.

Medical Research Analyst

CyPath® Lung’s high performance in clinical trials, as highlighted by its high sensitivity, specificity and accuracy, is critical for its adoption. Sensitivity measures the test's ability to correctly identify those with the disease (true positive rate), while specificity measures the ability to identify those without the disease (true negative rate). High values in both these metrics suggest that CyPath® Lung is an effective diagnostic tool, reducing the chances of false positives and negatives. This efficacy is likely driving the enthusiasm among physicians, leading to organic growth through word-of-mouth recommendations. The noninvasive nature of the test, using sputum samples analyzed via advanced flow cytometry, further supports its adoption, as it provides a less intrusive option for patients compared to traditional methods like biopsies.

Market Research Analyst

The successful expansion and adoption of CyPath® Lung beyond Texas into eight other states is important from a market penetration perspective. Early expansion suggests that the product is not only meeting but exceeding market needs, which is a positive indicator for potential national roll-out. The company's ability to onboard new practices rapidly aligns with the broader industry trend towards noninvasive diagnostic tools, which are becoming increasingly favored due to their patient-friendly nature. Additionally, the projected $4.7 billion lung cancer diagnostics market by 2030 presents a substantial opportunity for bioAffinity Technologies to capture a significant portion of this growing market. Investors should watch for continued reports of adoption rates and any updates on national expansion efforts as key indicators of future performance.

Sales of CyPath® Lung tests, onboarding of pathology practices ahead of forecasts

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 and lung disease, today reported 139% growth in the number of pulmonology practices and physicians offering CyPath® Lung to patients since Jan. 1, 2024. CyPath® Lung is a noninvasive test to detect early-stage lung cancer.

CyPath® Lung sales are ahead of Q1 2024 targets for the previously announced test market launch in Texas and have expanded to include pulmonology practices in eight other states, including New Jersey, Ohio, Pennsylvania, Michigan, North Carolina, California, Florida and Arizona. The earlier-than-expected expansion outside of Texas is primarily due to physician-to-physician word of mouth. In May, the Company increased the sales forecast provided in the 2023 Annual Report by 35%. The lung cancer diagnostics market is projected to reach $4.7 billion by 2030, according to ReportLinker’s industry analysis.

“As more physicians learn about CyPath® Lung and incorporate it into their practices, enthusiasm and excitement about the test has grown exponentially. The high sensitivity, specificity and accuracy of CyPath® Lung shown in our most recent clinical trial benefit both physicians and patients by providing actionable results and a clearer path forward for the early detection of lung cancer,” bioAffinity Technologies’ President and CEO Maria Zannes said. “Our marketing efforts have been very successful in demonstrating the value of CyPath® Lung to physicians. We continue to onboard practices in both Texas and beyond, fortifying the foundation for our national expansion.”

Pulmonologists and other lung health specialists understand the critically important role of screening and early diagnosis in improving outcomes for those diagnosed with lung cancer and providing peace of mind for individuals at elevated risk of developing the disease. By combining the simplicity of sputum as a biological sample with advanced flow cytometry and automated analysis, CyPath® Lung gives physicians a valuable diagnostic tool for patients with indeterminate pulmonary nodules. bioAffinity Technologies' commitment to noninvasive cancer detection is poised to reshape the landscape of lung health management by increasing early detection and treatment.

About CyPath® Lung

CyPath® Lung uses 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, 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 cancer can improve outcomes and increase patient survival.

About bioAffinity Technologies, Inc.

bioAffinity Technologies, Inc. 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. Research and optimization of the Company’s platform technologies are conducted in its laboratories at Precision Pathology and The University of Texas at San Antonio. 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 the Company continuing to onboard practices in both Texas and beyond, fortifying the foundation for the Company’s national expansion; increased sales ahead of forecasts provided in the 2023 Annual Report; the lung cancer diagnostics market being projected to reach $4.7 billion by 2030; CyPath® Lung benefitting both physicians and patients by providing actionable results and a clearer path forward for the early detection of lung cancer; CyPath® Lung giving physicians a valuable diagnostic tool for patients with indeterminate pulmonary nodules; and bioAffinity Technologies' commitment to noninvasive cancer detection being poised to reshape the landscape of lung health management by increasing early detection and treatment. 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 Company’s ability to meet its forecasts, continue its growth and expansion; the ability of the Company to capitalize on the lung cancer diagnostics market; the ability of CyPath® Lung to provide the anticipated benefits to patients and physicians and reshape the landscape of lung health management by increasing early detection and treatment; 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/20240612944228/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 the growth percentage in the number of pulmonology practices offering CyPath® Lung since January 1, 2024?

BioAffinity Technologies reported a 139% growth in the number of pulmonology practices and physicians offering CyPath® Lung since January 1, 2024.

Which states have expanded to include CyPath® Lung tests beyond Texas?

CyPath® Lung tests have expanded to New Jersey, Ohio, Pennsylvania, Michigan, North Carolina, California, Florida, and Arizona.

By what percentage did BioAffinity Technologies increase its 2023 sales forecast in May?

BioAffinity Technologies increased its 2023 sales forecast by 35% in May.

What is the projected market size of the lung cancer diagnostics market by 2030?

The lung cancer diagnostics market is projected to reach $4.7 billion by 2030.

What factors have contributed to the early expansion of CyPath® Lung outside of Texas?

The early expansion of CyPath® Lung outside of Texas is primarily due to positive physician-to-physician word of mouth and effective marketing strategies.

What are the key attributes of CyPath® Lung that have been well-received by physicians?

CyPath® Lung's high sensitivity, specificity, and accuracy have been key attributes well-received by physicians.