Detecting lung cancer early with advanced flow cytometry
bioAffinity Technologies addresses the urgent need for noninvasive, early-stage cancer diagnosis and targeted cancer treatment. Our first product, CyPath® Lung, accurately diagnoses early-stage lung cancer, the leading cause of cancer-related deaths.
The Power of Three
Early Detection of Cancer saves Lives
CyPath® Lung Test for Lung Cancer
Addressing a critical need to find cancer early and treat cancer specifically, bioAffinity Technologies develops tests and therapies to detect and treat cancer at the cellular level. Our first product, CyPath® Lung , has been licensed by Precision Pathology Services for commercial sale as a Laboratory Developed Test.
Specificity ⃰
⃰ In individuals at high risk for lung cancer with nodules less than 20 mm, (n=132)
Precision Pathology Services
Learn More about CyPath® Lung
CyPath® Lung has been licensed by Precision Pathology Services for commercial sale as a Laboratory Developed Test (LDT).
CyPath® Lung is a non-invasive test that assists clinical decision-making in lung cancer patients whose low-dose computed tomography (LDCT) has demonstrated a suspicious finding.
The test reveals the lung micro-environment by automated analysis of sputum using flow cytometry to characterize cell populations indicative of cancer in the lung.
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CyPath® FAQ
Early Detection of Lung Cancer Saves Lives
Screening is an important tool to find lung cancer at the earliest stages and increase survival. The current protocol for screening people at high risk for lung cancer uses low-dose computed tomography (LDCT) to identify nodules in the lungs. But LDCT has a low positive predictive value that can lead to unnecessary invasive procedures.
Physicians order CyPath® Lung for patients who receive a suspicious but indeterminant LDCT result. CyPath® Lung has the potential to dramatically increase overall diagnostic accuracy leading to increased survival, fewer unnecessary invasive procedures, and lower patient anxiety and medical costs.
At-Home Sample Collection
With the at-home sample collection kit, patients use a simple noninvasive assist device that breaks up mucus in the lung to cough up a sputum sample over three days and overnight it to the lab.
Flow Cytometry
Advanced flow cytometry is used to profile the micro-environment of the lung and detect lung cancer. A specific porphyrin labels cells in a sample to indicate cancer is present in the lung.
Automated Data Analysis
Automated data analysis is built into the process that identifies cancer in the lung, with results in minutes. Physicians receive test results within three days after the sample arrives at the lab.
Summary Of CyPath® Lung Research And Clinical Studies
Study Description |
Results |
| Porphyrin-modified beads for use as compensation controls in flow cytometry (Bauta, et al, Journal of Visualized Experiments, 2023) | TCPP-modified compensation beads for flow cytometry allow TCPP fluorescence in sputum samples to be distinguished from other fluorescent molecules |
| Automated flow cytometry test distinguishes cancer from non-cancer in sputum with high sensitivity and specificity (Lemieux et al, Respiratory Research, 2023) | Test validation trial using bioAffinity’s automated flow cytometry platform (cancer N=28 / high risk N=122) results in 82% sensitivity and 88% specificity; CyPath Lung sensitivity is 92% and specificity is 87% for patients with nodules smaller than 2 cm |
| Quality-controlled sputum analysis by flow cytometry to analyze the lung environment (Bederka, et al, PLOS ONE, 2022) | Research confirms that bioAffinity has developed and tested a novel flow cytometry assay including quality controls that analyzes sputum in a high-throughput manner for diagnosis of lung cancer and other lung diseases (N=140) |
| Quality-controlled sputum analysis by flow cytometry for lung cancer detection (Grayson, et al., Journal of Visualized Experiments, 2021) | Demonstrating the method for sputum processing that can be applied to flow cytometry platforms to analyze the sample for the diagnosis of lung disease including lung cancer, COPD and asthma |
| Early detection of lung cancer with Meso-Tetra (4-Carboxypheyl) Porphyrin-Labeled Sputum (Patriquin, et al, Journal of Thoracic Oncology, 2015) | Clinical trial of high-risk smokers and cancer patients used microscopy-based assay to identify TCPP-labeled cells in sputum (cancer N=26 / high risk N =102) that resulted in 81% accuracy; 77.9% sensitivity, 65.7% specificity |
| Internal validation study with microscopy-based assay TCPP labeling of sputum in lung cancer samples | Researchers measured TCPP-labeled cells under a microscope (cancer N= 15 / healthy N=12) resulting in 100% sensitivity and 100% specificity |
| Blinded study to diagnose lung cancer by labeling sputum with TCPP under a microscope | Study of uranium miners (cancer N=8 / healthy N=4) labeling sputum with TCPP resulted in 100% sensitivity and 100% specificity |
| Porphyrin’s localization and evaluation of cancer cell uptake of 4 different porphyrins | TCPP porphyrin localizes more than other porphyrins in cancer cells; higher uptake of TCPP in cancer cells than normal cells |
Precision Pathology Services laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as certified to perform high complexity clinical laboratory testing.
Research & Development Efforts
Scientific Publications & Abstracts
bioAffinity’s Diagnostics Efforts
CyPath® uses a porphyrin molecule that displays an unusually high affinity to bind to cancer cells that fluoresce brightly when labeled to distinguish cancer from non-cancer cells using flow cytometry.
Our innovative scientific research is aimed at developing non-invasive diagnostics for various cancers and other lung diseases. Our first test, CyPath® Lung, is available through Precision Pathology Services to physicians for their patients at high risk for lung cancer.
This animated video produced by the Massachusetts Institute of Technology (MIT) Star CellBio introduces flow cytometry, a technique in which cells are suspended in a fluid and flow one at a time through a focus of exciting light, which is scattered in patterns characteristic to the cells and their components.
bioAffinity’s Therapeutics Efforts
Through our subsidiary, OncoSelect® Therapeutics, our company focuses on advancing discoveries related to broad-spectrum cancer therapeutics. In researching porphyrins’ selectivity for cancer, we discovered novel therapies that kill cancer cells without harm to normal cells in vitro.
We will continue with animal studies to advance our discoveries, including the possibility of attaching cancer-killing cytotoxic drugs to porphyrins, a cancer-selective molecule that is taken up by tumors in much greater amounts than by non-cancer tissue.
Animation of a Porphyrin molecule
bioAffinity’s Therapeutics Efforts
Through our subsidiary, OncoSelect® Therapeutics, our company focuses on advancing discoveries related to broad-spectrum cancer therapeutics. In researching porphyrins’ selectivity for cancer, we discovered novel therapies that kill cancer cells without harm to normal cells in vitro.
We will continue with animal studies to advance our discoveries. Our research also looks to attach cancer-killing cytotoxic drugs to porphyrins, a cancer-selective molecule that is taken up by tumors in much greater amounts than by non-cancer tissue.
Animation of a Porphyrin molecule