bioAffinity Technologies Reports 217% Sales Growth in Second Quarter 2024 for CyPath® Lung
bioAffinity Technologies (Nasdaq: BIAF) reported a remarkable 217% increase in second-quarter 2024 sales for CyPath® Lung over the first quarter. The company raised its full-year forecast for CyPath® Lung sales by 85%, significantly surpassing the previous forecast by 75%. CyPath® Lung is positioned as a important noninvasive test for early lung cancer detection, especially beneficial for patients with pulmonary nodules. The lung cancer diagnostics market is expected to reach $4.7 billion by 2030. bioAffinity strategically launched CyPath® Lung in Texas, leveraging Medicare reimbursement and CPT code authorization. The company projects 2024 revenue between $9.2 and $9.6 million from its subsidiary, Precision Pathology Laboratory Services (PPLS), which bills $1,900 per test. Sales are expanding nationally with physicians from eight other states ordering the test. A broader market launch is planned for Q4 2024.
- 217% growth in second-quarter 2024 sales over first quarter.
- Raised full-year forecast for CyPath® Lung sales by 85%.
- Projected revenue of $9.2-$9.6 million in 2024 from PPLS.
- Secured Medicare reimbursement and CPT code for CyPath® Lung.
- Expanded sales team and national adoption beyond Texas.
- None.
The reported 217% growth in second-quarter sales for CyPath® Lung is significant, especially in the context of the company’s recent strategic initiatives. Such a robust increase suggests a strong market reception and effective sales strategy execution. The company's revised full-year forecast, now 85% higher, shows confidence in continued momentum. Importantly, this growth outpaced their prior forecast by 75%, indicating a high level of demand and potentially undervalued initial expectations.
The projected revenue for the subsidiary PPLS, ranging between
The lung cancer diagnostics market, projected to reach
bioAffinity’s focused strategy in Texas, the third-largest market for pulmonologists, has allowed the company to establish a solid customer base and fine-tune its operations. The broader market expansion planned for the fourth quarter of 2024 is an essential step and its success depends on scaling these operations without compromising performance. The increasing adoption of the test by physicians in other states, driven by peer referrals, is a positive indicator of its clinical acceptance and potential for wider adoption.
CyPath® Lung addresses a critical gap in lung cancer diagnostics, particularly for patients with indeterminate pulmonary nodules. The use of sputum samples combined with advanced flow cytometry offers a user-friendly and noninvasive option, which could significantly impact patient outcomes. The high sensitivity and specificity rates are particularly relevant for early-stage detection, which can lead to better prognoses and treatment options.
The addition of private insurers covering the test bolsters its accessibility and market penetration. Medicare reimbursement already in place further legitimizes its clinical utility and can drive broader adoption. The incremental increase in test orders, from 12 in Q4 2023 to 168 in Q2 2024, underscores CyPath® Lung’s growing acceptance among physicians and its potential to become a standard diagnostic tool in pulmonology practices.
Sales of CyPath® Lung tests continue to accelerate as sales team expands customer base of pulmonology practices
CyPath® Lung fulfills the need for a noninvasive test for the early detection of lung cancer and is especially useful for patients whose lung cancer screening or other scan reveals a pulmonary nodule. The lung cancer diagnostics market is projected to reach
The accelerating growth of CyPath® Lung sales builds on the foundation laid in 2023 when bioAffinity launched a strategic beta marketing program in
“We strategically focused our marketing efforts on our home state of
In the second quarter of 2024, physicians ordered 168 CyPath® Lung tests. Based on the accelerating pace of test orders, the Company has raised its forecast for 2024 CyPath® Lung sales to exceed 880 tests. “In the fourth quarter of 2023, we processed 12 CyPath® Lung tests. That number increased to 53 tests in the first quarter of 2024 and now 168 tests in the second quarter,” Ms. Zannes said.
In addition to critical care pulmonologists who are considered opinion leaders in advancing innovative lung cancer diagnostics like CyPath® Lung, other physician specialties that may use the test for their high-risk patients include general pulmonologists and primary care physicians.
“Lung cancer screening and early diagnosis improve outcomes and extend lives for patients at high risk for lung cancer. But imaging is not always definitive, especially for pulmonary nodules smaller than 20 millimeters,” Ms. Zannes said. “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 with high sensitivity and specificity for high-risk patients, especially those with indeterminate nodules. And their patients appreciate the user-friendly, noninvasive design of the test.”
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 that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath® Lung had
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other 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 raising the full-year forecast for sales of CyPath® Lung, PPLS generating between
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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 growth did bioAffinity Technologies (BIAF) report for CyPath® Lung sales in Q2 2024?
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