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The workforce reduction is among several proactive steps the company is taking to accelerate CyPath Lung sales growth.
March 18, 2025
By: Michael Barbella
Managing Editor
bioAffinity Technologies Inc. is taking some targeted steps to improve save $4 million in costs and accelerate the commercial growth of CyPath Lung, the company’s noninvasive test for early-stage lung cancer. The savings is expected to impact bioAffinity’s subsidiary Precision Pathology Laboratory Services (PPLS) while increasing resources to expand CyPath Lung sales in high-potential national markets.
“Following our acquisition of PPLS, we embarked on a deliberate and strategic review as part of our commitment to optimizing operations and accelerating CyPath Lung sales. We believe our changes at PPLS support and enhance bioAffinity’s commercial strategy to fast-track market expansion and sales of CyPath Lung while continuing to provide PPLS clients with anatomical pathology services as it has done for more than 25 years,” bioAffinity President/CEO Maria Zannes said. “We will continue to rely on the combined innovation and expertise of both bioAffinity and PPLS employees to achieve our planned 2025 milestones, including starting enrollment for the FDA pivotal trial for CyPath Lung and development of additional noninvasive diagnostics, including tests for COPD and asthma.”
Specifically, bioAffinity Technologies expects to achieve the majority of the $4 million in cost savings on an annual run rate through:
With year-over-year sales growth, CyPath Lung remains the focal point of bioAffinity’s commercial strategy. “Although these actions are expected to result in a decrease in revenue, they are also expected to improve profitability at our PPLS subsidiary by focusing on CyPath Lung and other high-value service lines,” bioAffinity Chief Financial Officer Michael Edwards said.
“Our strategic adjustments today enhance our readiness to serve the market for noninvasive lung cancer detection in both civilian and military healthcare systems, and we continue to see increasing sales as more and more physicians incorporate CyPath Lung into their protocol for patients at high risk for lung cancer,” Zannes stated. “With CyPath Lung now available for purchase through the Federal Supply Schedule, we intend to launch a focused government marketing program next quarter to introduce the test to Veterans Administration and Department of Defense medical centers.”
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 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.
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.
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