bioAffinity Expands CyPath Lung Toward Monitoring Lung Cancer Survivors

Key Points

• bioAffinity Technologies is advancing CyPath® Lung for use in monitoring lung cancer survivors after treatment.
• The noninvasive sputum-based test is designed to provide additional information alongside imaging and physician evaluation, not replace standard diagnostic procedures.
• CyPath Lung uses flow cytometry, a fluorescent porphyrin, and artificial intelligence to identify cell populations associated with lung cancer.
• The company is pursuing further clinical validation through a large longitudinal study involving high-risk patients with lung nodules.

bioAffinity Technologies (Nasdaq: BIAF) is broadening the potential use of its CyPath Lung test to help physicians monitor people who have previously been treated for lung cancer.

The company’s strategy is to position CyPath Lung as an additional clinical tool for lung cancer survivor surveillance, a setting where patients may require ongoing monitoring for recurrence after treatment.

A Noninvasive Test Designed to Support Follow-Up Care

CyPath Lung is a sputum-based laboratory-developed test offered through bioAffinity’s Precision Pathology Laboratory Services subsidiary. It is designed to analyze cells collected from a patient’s sputum sample, providing physicians with additional information that may help assess cancer risk.

The test uses flow cytometry, a fluorescent porphyrin that is intended to be preferentially absorbed by cancer and cancer-related cells, and proprietary artificial intelligence to identify cell populations associated with malignancy.

bioAffinity is not positioning CyPath Lung as a replacement for CT scans, biopsies, or physician judgment. Instead, the company says the test may be used alongside imaging, medical history, and other clinical findings to help guide patient management.

Targeting an Ongoing Need for Survivor Monitoring

Lung cancer survivors typically undergo ongoing follow-up care after treatment because of the possibility of recurrence or the development of a new lung cancer. bioAffinity believes CyPath Lung may give clinicians a noninvasive way to add information during that monitoring process.

The company has previously described clinical protocols that include CyPath Lung in survivor surveillance, pulmonary nodule assessment, early lung cancer detection, and evaluation of patients being considered for more invasive procedures. The goal is to help physicians better understand risk and potentially reduce unnecessary procedures when test results and imaging findings support a lower-risk assessment.

Prior Results in High-Risk Nodule Patients

CyPath Lung has previously been evaluated in patients considered at high risk for lung cancer who had small, indeterminate pulmonary nodules measuring less than 20 millimeters.

In that earlier clinical study, bioAffinity reported:

• 92% sensitivity.
• 87% specificity.
• 88% overall accuracy.
• 99% negative predictive value.

These results were reported for the pulmonary-nodule study population. They should not be viewed as established performance figures for lung cancer survivor surveillance, which represents a separate potential application and will require its own supporting evidence.

Large Study Aims to Generate More Clinical Evidence

bioAffinity began a planned longitudinal clinical study in March 2026 involving its investigational FlowPath Lung assay, which uses the same underlying technology and procedures as CyPath Lung. The FlowPath name is used in the research setting to distinguish the investigational assay from the commercially marketed CyPath Lung test.

The study is expected to enroll up to 2,000 high-risk patients with lung nodules measuring from 6 mm to less than 30 mm. It may involve up to 20 sites, including Department of Veterans Affairs locations and military hospitals.

Patients may be followed for up to 24 months, or until physicians reach a definitive cancer or no-cancer determination. The study is designed to generate additional evidence on the test’s clinical performance in a larger real-world population.

What the Expansion Could Mean for Investors

The survivor-surveillance initiative could expand CyPath Lung’s potential addressable market beyond initial screening and pulmonary-nodule evaluation. If supported by clinical data and adopted by physicians, the test could become part of longer-term patient-monitoring workflows after lung cancer treatment.

For investors, however, the opportunity remains dependent on several factors: completion of ongoing clinical studies, performance in additional patient populations, physician adoption, reimbursement progress, laboratory capacity, and the ability to integrate the test into established care pathways.

The company’s latest update signals an effort to broaden CyPath Lung’s clinical relevance. It does not establish the test as a standard-of-care option for monitoring lung cancer survivors, and the previously reported study metrics apply to high-risk patients with indeterminate pulmonary nodules rather than the survivor-surveillance population.