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SAN ANTONIO - bioAffinity Technologies, Inc. (NASDAQ:BIAF; BIAFW), a biotechnology company specializing in noninvasive early-stage cancer diagnostics, announced a significant uptick in its sales forecast for the CyPath® Lung test. The company has increased its full-year sales projection by 85%, following a 217% growth in second-quarter sales compared to the first quarter of 2024.
CyPath® Lung is designed to detect early-stage lung cancer through a noninvasive method, particularly beneficial for patients with pulmonary nodules. The test's market potential is underscored by industry projections that anticipate the lung cancer diagnostics market to reach $4.7 billion by 2030.
The surge in sales is attributed to the expansion of bioAffinity's customer base among pulmonology practices, particularly in Texas, where the company initially launched its strategic beta marketing program in 2023. This growth was supported by obtaining a CPT code and Medicare reimbursement, alongside private insurers beginning to cover the test, which is billed at $1,900.
The company's President and CEO, Maria Zannes, highlighted the strategic focus on Texas, which has the third-largest market of critical care pulmonologists in the U.S. According to Zannes, the physicians currently using CyPath® Lung in Texas account for 10% of the state's critical care pulmonology market. Orders for the test have also been received from physicians in eight other states.
With the expanded sales team actively onboarding new physicians, bioAffinity has adjusted its 2024 sales forecast to exceed 880 CyPath® Lung tests. Precision Pathology Laboratory Services (PPLS), a subsidiary of bioAffinity, is expected to generate revenue between $9.2 and $9.6 million in 2024, inclusive of CyPath® Lung sales.
CyPath® Lung operates by using advanced flow cytometry and artificial intelligence to analyze patient sputum samples for signs of malignancy. Clinical studies have shown the test to have 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high-risk patients with small lung nodules.
The company plans to prepare for a broader market launch of CyPath® Lung in the fourth quarter of 2024. This announcement is based on a press release statement from bioAffinity Technologies.
In other recent news, bioAffinity Technologies has seen a 21% increase in April sales of its CyPath Lung diagnostic test, expanding its reach beyond its initial Texas market to states like New Jersey, Pennsylvania, Michigan, and North Carolina.
The company has strengthened its sales team with the hiring of Jackie Kennedy as the Pulmonary Sales Executive for the San Antonio/Austin region and Jessica Alarcon as a Patient Coach to assist with the sputum sample collection process. Furthermore, bioAffinity is set to contribute to lung cancer diagnostics research at the American Thoracic Society's Annual Conference in San Diego.
In a parallel development, the company has appointed David Elzi, Ph.D., as Vice President of Product Development to expedite the advancement of new diagnostic tests. Dr. Elzi, who has been leading the company's research team for eight years, is currently advancing two diagnostic products in the development phase.
These developments are part of a collaboration with the Brooke Army Medical Center to explore alternatives to annual low dose computed tomography screening and assess if CyPath Lung can predict cancerous lung nodules before more invasive procedures are required.
These are among the recent developments at bioAffinity Technologies, a company that continues to focus on the early detection of serious lung health issues.
InvestingPro Insights
bioAffinity Technologies, Inc. (NASDAQ:BIAF; BIAFW) has demonstrated a notable financial trajectory as it positions itself in the lung cancer diagnostics market. The company's recent sales forecast uptick is supported by encouraging real-time data. According to InvestingPro, bioAffinity's market capitalization stands at $27.63 million, reflecting investor confidence in the potential of its CyPath® Lung test.
InvestingPro data highlights a staggering 86167.8% revenue growth over the last twelve months as of Q1 2024, with a gross profit margin of 32.88%. This rapid increase in revenue, although starting from a low base, is indicative of the company's scaling operations and market penetration. Furthermore, the company's significant return over the last week of 9.22% aligns with the positive sales news, suggesting that the market is reacting favorably to the company's developments.
While bioAffinity does not pay a dividend to shareholders, which is common for growth-focused biotech companies, InvestingPro Tips reveal that the company's liquid assets exceed short-term obligations. This financial stability is critical for sustaining its expansion and research endeavors. Moreover, the company operates with a moderate level of debt, which is an important consideration for investors assessing the risk profile of a company in a capital-intensive industry.
For readers interested in a deeper dive into bioAffinity's financial health and future prospects, there are additional InvestingPro Tips available. These insights can be accessed through InvestingPro's platform, which currently lists a total of 7 tips for BIAF, providing a comprehensive analysis of the company's financials and market performance. Investors looking to capitalize on these expert insights can use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
As bioAffinity Technologies continues to grow and capture market share, these InvestingPro metrics and tips could serve as valuable resources for investors tracking the company's progress and potential in the evolving landscape of cancer diagnostics.
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