bioAffinity Technologies (BIAF) FDA Approvals

bioAffinity Technologies' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by bioAffinity Technologies (BIAF). Over the past two years, bioAffinity Technologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CyPath. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

CyPath FDA Regulatory Timeline and Events

CyPath is a drug developed by bioAffinity Technologies for the following indication: For detection of early-stage lung cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Provided Update - April 28,2026

• Drug: CyPath
• Announced Date: April 28, 2026
• Indication: For detection of early-stage lung cancer

bioAffinity Technologies, Inc. announced a pilot study with Brooke Army Medical Center (BAMC) to evaluate the Company's proprietary tests under development to identify specific inflammatory biomarkers for asthma and chronic obstructive pulmonary disease (COPD).

bioAffinity Technologies announced a pilot study with Brooke Army Medical Center to test the company’s proprietary flow cytometry + AI diagnostic methods for identifying inflammatory biomarkers in asthma and COPD. The study plans to enroll about 40 people divided into three cohorts: asthma patients, COPD patients, and healthy controls. Researchers will collect sputum samples and use automated analysis to measure specific immune cells and cytokines. The goal is to find markers that can guide treatment choices and monitor therapy effectiveness.

The collaboration builds on bioAffinity’s CyPath Lung pipeline and targets a respiratory treatment market estimated at $92 billion. The study is important because asthma is not a single disease and can present differently in military personnel exposed to unique environmental and deployment-related hazards. Improved, precise diagnostics could help tailor treatments and better track patient responses.Read Announcement

Clinical Study - April 14,2026

• Drug: CyPath
• Announced Date: April 14, 2026
• Indication: For detection of early-stage lung cancer

bioAffinity Technologies, Inc released a new clinical case study illustrating how CyPath® Lung, the Company's noninvasive sputum-based diagnostic test, helped determine next steps for a high-risk patient with a suspicious pulmonary nodule where imaging and risk models suggested a high likelihood of cancer, but the physician suspected possible inflammation.

bioAffinity Technologies released a clinical case study showing how its CyPath® Lung test helped guide care for a high‑risk patient with a 30‑millimeter pulmonary nodule. Standard imaging and risk calculators suggested a high probability of cancer, but the treating pulmonologist suspected the finding might be inflammatory and ordered the noninvasive, sputum‑based CyPath Lung test.

CyPath Lung returned an "Unlikely Malignancy" result, prompting a follow‑up CT before proceeding to biopsy. The follow‑up scan showed the nodule had completely resolved, confirming a reversible inflammatory process rather than cancer. In a prior clinical trial of high‑risk patients with small nodules, CyPath Lung demonstrated 92% sensitivity, 87% specificity and 88% accuracy.

The company says this case illustrates how the test can help physicians defer unnecessary, often risky invasive procedures, though it represents a single patient experience and does not establish broader clinical utility.

Clinical Study - February 17,2026

• Drug: CyPath
• Announced Date: February 17, 2026
• Indication: For detection of early-stage lung cancer

bioAffinity Technologies, Inc announced a new clinical case study demonstrating how CyPath® Lung, its noninvasive diagnostic test for lung cancer, supported clinical decision-making in a high-risk patient with multiple pulmonary nodules.

bioAffinity Technologies reported a clinical case showing how its noninvasive CyPath® Lung test helped guide care for a high‑risk patient with multiple small lung nodules. The 59‑year‑old man had a long smoking history and COPD, and CT scans showed several 3–7 mm nodules categorized as Lung‑RADS 3, a finding usually considered probably benign but worrisome in smokers. The CyPath® Lung result was negative ("unlikely malignancy"), which gave the pulmonologist and the patient added confidence to follow the recommended six‑month CT surveillance. On follow‑up imaging the nodules remained stable.

CyPath® Lung has shown 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer in nodules under 2 cm. In this case the test provided objective information that reduced anxiety, reinforced guideline‑consistent monitoring, and may help avoid unnecessary invasive procedures while keeping careful watch for cancer in high‑risk patients.

Presentation - October 20,2025

• Drug: CyPath
• Announced Date: October 20, 2025
• Indication: For detection of early-stage lung cancer

bioAffinity Technologies, Inc announced it will present research at CHEST 2025, the annual meeting of the American College of Chest Physicians.

Provided Update - July 9,2025

• Drug: CyPath
• Announced Date: July 9, 2025
• Indication: For detection of early-stage lung cancer

bioAffinity Technologies, Inc today released a new case study of a complex clinical case in which CyPath® Lung identified Stage 1A adenocarcinoma lung cancer in a patient whose PET imaging and risk model probability indicated a low risk of malignancy.

bioAffinity Technologies, Inc. released a case study showing how its noninvasive CyPath® Lung test played a crucial role in diagnosing early-stage lung cancer. In a challenging case, a patient’s PET imaging and risk models indicated a very low chance of malignancy—a 0.2% probability—yet the CyPath® Lung test returned a positive result. The test’s score of 0.83 helped reveal a Stage 1A adenocarcinoma, prompting doctors to choose surgical intervention over routine annual CT surveillance. This early detection was critical, as traditional imaging and risk calculators did not provide enough evidence to justify invasive procedures. Early diagnosis is key in fighting lung cancer, and CyPath® Lung’s ability to detect malignancy when other methods fall short may help improve patient outcomes in similar cases.

Provided Update - March 19,2025

• Drug: CyPath
• Announced Date: March 19, 2025
• Indication: For detection of early-stage lung cancer

bioAffinity Technologies, Inc today released a study of a complex clinical case in which CyPath® Lung's real-time assessment of the lung microenvironment identified a hidden recurrence of breast cancer in an 80-year-old high-risk patient.

bioAffinity Technologies, Inc. released a study highlighting a complex clinical case where their CyPath® Lung test was key in detecting a hidden recurrence of breast cancer in an 80-year-old high-risk patient. The patient, a former smoker with COPD who had previously been treated for breast cancer, was being monitored for lung issues. During routine low-dose CT scans, an indeterminate nodule raised concerns. Traditional methods like PET scans and serum markers were not ideal for further clarification. However, the CyPath® Lung test provided a real‐time assessment of the lung microenvironment, suggesting a likely malignant nodule. This result prompted the care team to conduct a follow-up mammogram, which confirmed a new breast cancer recurrence. The study underscores the potential of CyPath® Lung to guide oncological decision-making and reduce the need for more invasive diagnostic procedures.

Provided Update - March 13,2025

• Drug: CyPath
• Announced Date: March 13, 2025
• Indication: For detection of early-stage lung cancer

bioAffinity Technologies, Inc announced the release of physicians' case studies showing the benefit to patients and their doctors of using CyPath® Lung, the Company's noninvasive test for early detection of lung cancer.

bioAffinity Technologies, Inc. has released physicians’ case studies highlighting the benefits of using its CyPath® Lung test, a noninvasive method for detecting early lung cancer. The case studies show that CyPath® Lung can help both patients and doctors avoid unnecessary invasive procedures. In one detailed example, an 85-year-old patient at high risk for lung cancer was spared a robotic bronchoscopic biopsy after the test indicated “Unlikely Lung Cancer,” allowing the patient and his doctor to choose watchful waiting instead. This decision led to the resolution of pulmonary nodules over three months.

Dr. Gordon Downie from Titus Regional Medical Center noted that CyPath® Lung provided critical additional information in managing small nodules, enabling a safer approach compared to more invasive options. bioAffinity’s CEO, Maria Zannes, emphasized that these results demonstrate how the test can reduce anxiety and lower healthcare costs by avoiding risky procedures.

Patent Application - January 22,2025

• Drug: CyPath
• Announced Date: January 22, 2025
• Indication: For detection of early-stage lung cancer

bioAffinity Technologies, Inc announced that the Australian Patent Office (IP Australia), has accepted bioAffinity's patent application for the method of predicting the likelihood of lung cancer used by the CyPath® Lung diagnostic test for early-stage lung cancer.

bioAffinity Technologies, Inc. announced that IP Australia has accepted its patent application for the method used in its CyPath® Lung diagnostic test. This patent covers a process that utilizes automated flow cytometry combined with machine learning to predict the likelihood of lung cancer, thereby aiding early-stage detection.

Once issued, the patent will be valid until 2042, marking a significant addition to the company’s intellectual property portfolio. The acceptance underlines the global potential of bioAffinity's innovation in noninvasive lung cancer screening. The CyPath® Lung test, which highlights malignancy in sputum samples using a fluorescent porphyrin and sophisticated data analysis, stands out as a promising tool to pinpoint early lung cancer when treatments are most effective.

Provided Update - January 13,2025

• Drug: CyPath
• Announced Date: January 13, 2025
• Indication: For detection of early-stage lung cancer

bioAffinity Technologies, Inc today reported the results of the Company's CyPath® Lung pilot marketing program using Texas for our beta launch with sales of more than 600 tests delivered in 2024.

bioAffinity Technologies, Inc. announced the successful beta launch of its CyPath® Lung pilot marketing program in Texas, delivering over 600 tests in 2024. This achievement highlights the company’s growing impact in noninvasive lung cancer detection and early diagnosis of lung disease. The pilot program has attracted increasing interest from physicians and pulmonary practices, supporting future plans for broader market adoption.

Looking ahead, bioAffinity plans to build on its recent momentum by further expanding its marketing efforts and integrating CyPath® Lung into the U.S. Federal Supply Schedule. This step will make the test available to Veterans and active military personnel across U.S. government health systems, enhancing patient care and early lung cancer detection even more. The success of the Texas beta launch marks a significant milestone in the company’s mission to improve outcomes for patients at risk.

Provided Update - September 18,2024

• Drug: CyPath
• Announced Date: September 18, 2024
• Indication: For detection of early-stage lung cancer

bioAffinity Technologies announced that CyPath® Lung Test Shows Potential Significant Healthcare Savings by Reducing Unnecessary Follow-Up, Medical Complications and Overdiagnosis

The recent study by researchers at Brooke Army Medical Center and the South Texas Veterans Health Care Systems highlights the potential economic benefits of using bioAffinity Technologies’ CyPath® Lung test for early lung cancer detection. The noninvasive test, which uses advanced flow cytometry and AI, may reduce the need for further diagnostic assessments and invasive procedures. For Medicare patients, integrating CyPath® Lung into the standard screening process could save about $2,773 per patient, reaching total savings of $379 million in 2022. For privately insured patients, the savings may be even higher, averaging $6,460 per patient and totaling around $895 million. By decreasing unnecessary follow-up procedures and reducing procedure-related complications, the test not only helps lower overall healthcare costs but also minimizes overdiagnosis and improves patient outcomes by facilitating earlier and more effective lung cancer diagnosis.