bioAffinity Technologies (NASDAQ:BIAF) hosted a “CyPath Lung in Practice” webinar featuring pulmonologists who described how they are using the company’s CyPath Lung sputum test to help triage patients with pulmonary nodules and reduce unnecessary invasive procedures.
Julie Anne Overton, Director of Communications at bioAffinity Technologies, opened the event by outlining logistics and noting the session would be recorded and posted at www.cypathlung.com. The discussion was moderated by Dr. Gordon Downie, the company’s Chief Medical Officer, who said the program would focus on the “clinical burden” of evaluating early lung cancer and pulmonary nodules in high-risk individuals, including those identified through screening, survivorship surveillance, or incidental findings.
Physicians describe rising nodule volumes and pressure on biopsy capacity
Dr. Greg White, a pulmonologist at CHRISTUS St. Michael Health System in Texarkana, said his system has seen “a huge influx of low-dose screening CTs,” estimating “about 120-150 a month now,” adding to a workflow where “you just can’t spend all day bronching.” White, who said he assesses about 500 pulmonary nodules a year, framed the issue simply: “Not every patient needs a procedure, and not every nodule needs a biopsy.”
On the East Coast, Dr. Michael Nicholson of Robert Wood Johnson University Hospital said the field is “inundated” with new biopsy tools, but less focused on selecting the right candidates: “Everything is about how do we biopsy better, but not who is the better person to biopsy.” Nicholson said his current community-based practice has “smaller amount of Ion time” compared with his training environment, which makes pre-test probability and resource allocation more important.
How clinicians say they use CyPath Lung in practice
The clinicians described using CyPath Lung as a noninvasive risk stratification tool early in the evaluation pathway, particularly for smaller nodules where PET imaging may be less reliable or when patients face higher procedural risk.
- Dr. Guda said his practice uses CyPath in patients where traditional tools such as the Mayo risk calculator are insufficient, or when nodules do not meet Lung-RADS 4B but biopsy is being considered. He described using sputum-based results to decide between biopsy and imaging follow-up “at a reasonable cadence.”
- Dr. Nicholson said CyPath is used “very early” in his algorithm, especially for nodules “less than 1.2 cm” where PET may be unreliable. He also emphasized the patient-anxiety component, describing scenarios where a clinician believes a small nodule is “probably nothing,” while an anxious patient “with ChatGPT thinks that this is the end of their life.”
- Dr. White said he uses CyPath both upstream and downstream—sometimes to decide whether to biopsy, and sometimes after a negative biopsy to assess whether the result is a “true negative” when combined with other clinical factors.
Downie also highlighted logistical benefits discussed by the panel, including the ability to mail the kit to patients. He said in his own practice it helped address stigma and access barriers, noting it can be completed “privately in their home” without travel.
Clinical trial metrics and how the test works
During a Q&A segment, Downie summarized performance statistics from what he said was a peer-reviewed, published clinical trial for CyPath Lung. He reported 92% sensitivity and 87% specificity, with results provided as a binary “likely” or “unlikely.” He also stated a 99% negative predictive value for nodules under 20 mm. Downie discussed positive predictive value as well, referencing 61%, and said predictive values vary by regional prevalence.
Responding to a question about biomarkers and detection, Downie said CyPath uses sputum processed through flow cytometry with AI-driven analysis. He described four main data elements feeding the algorithm:
- Porphyrin incubation to stain malignant cells
- Receptor stains to identify pulmonary macrophages and confirm a lung-derived sample
- Filtering to remove debris
- Identification of apoptotic cells and immune-active inflammatory cells to assess the lung microenvironment
On potential false positives or limitations, Downie said the company has launched a 2,000-patient study to refine understanding. He cited one identified issue: samples with heavy yeast burden in patients with “florid thrush” could interfere with flow cytometry gating, prompting the company to add active thrush as an exclusion criterion.
Case examples: when CyPath results changed the next step
Panelists provided cases where they said CyPath results helped move patients toward biopsy or, conversely, helped support surveillance.
Dr. Guda described a 66-year-old former smoker with ground-glass nodularity, including a lesion about 13 mm. He said PET was expected to be uninformative due to a small solid component. CyPath returned a “likely” result (he cited 0.7), prompting a robotic bronchoscopy with cryobiopsy that was “positive for adenocarcinoma.” Guda said the patient underwent a right upper lobectomy and had clear follow-up CT scans.
Dr. White described a 68-year-old active smoker referred for hemoptysis who was reluctant to undergo biopsy and preferred a three-month CT follow-up. White said the CT “screamed cancer,” and after a positive CyPath, the patient underwent biopsy showing “stage one cancer,” followed by resection.
Dr. Nicholson shared a case involving a patient being evaluated for a heart transplant who had a 6 mm right upper lobe nodule and was not an ideal candidate for general anesthesia. Nicholson said he proposed CyPath as a noninvasive option with a “99% negative predictive value,” highlighting the ability to send a kit to the patient’s home and arrange pickup.
Screening, stigma, and the future of “nodular lung disease” management
Panelists also discussed whether noninvasive testing could support screening efforts. Guda suggested some patients avoid CT screening due to fear of a cancer diagnosis and questioned whether sputum-based risk stratification could motivate follow-through. Nicholson said some patients in his area worry about radiation exposure and frequent CT follow-ups, arguing that “radiation-free” approaches may become more important in early detection.
White compared pulmonary’s trajectory to gastroenterology, suggesting the specialty may shift toward earlier intervention in “nodular lung disease.” He described CyPath as “the starting line” for a process that could eventually combine risk tools, biopsy, and treatment more seamlessly.
In closing remarks, Nicholson said having an additional noninvasive tool improved his confidence and patient communication, while White emphasized the test’s high negative predictive value as particularly useful for avoiding procedures. Guda said the test helps answer not only whether a biopsy can be done, but “should we?”
About bioAffinity Technologies (NASDAQ:BIAF)
bioAffinity Technologies, Inc (NASDAQ: BIAF) is a U.S.-based biotechnology company specializing in the development and commercialization of advanced in vitro diagnostic platforms for oncology. Leveraging proprietary bioaffinity and nanotechnology approaches, bioAffinity’s platforms are designed to isolate and analyze cancer-specific biomarkers from blood, tissue, and other biological samples with high sensitivity and specificity. The company’s core technologies aim to enable earlier detection of solid tumors, improved disease monitoring, and more personalized treatment strategies.
The company’s primary product pipeline includes assays targeting breast cancer and other solid tumor indications.
