On March 28, 2023 bioAffinity Technologies, Inc. (NASDAQ: BIAF; BIAFW) reported that the publication of a paper titled "Porphyrin-modified beads for use as compensation controls in flow cytometry" in the peer-reviewed Journal of Visualized Experiments (JoVE) (Press release, BioAffinity Technologies, MAR 28, 2023, View Source [SID1234629428]). The paper describes the protocol for preparing porphyrin-labeled compensation beads to optimize the results of bioAffinity’s CyPath Lung test to detect early-stage lung cancer.
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bioAffinity Technologies has an international patent pending for the proprietary compensation beads and their use in flow cytometry.
The publication of our peer-reviewed paper in JoVE is a recognition of our commitment to advancing innovative science in line with the Company’s mission of improving the survivability of lung cancer, the world’s deadliest cancer, through expanded screening and early diagnosis," said Maria Zannes, President and CEO of bioAffinity Technologies.
The beads act as an important control for our CyPath Lung assay by allowing the fluorescence of the porphyrin TCPP to be quantified more accurately," said William E. Bauta, Ph.D., Senior Vice President for Therapeutics at bioAffinity Technologies and inventor of the compensation beads. "The compensation beads we developed have improved the assay’s precision, lowered costs and accelerated sample processing.
As part of CyPath Lung processing, patient sputum samples are labeled with the fluorescent porphyrin TCPP (meso-tetra-(4-carboxyphenyl) porphine). TCPP preferentially binds to cancer and cancer-related cells in the sputum and fluoresces, which aids in the detection of early-stage lung cancer. bioAffinity’s TCPP-modified compensation beads are used with the flow cytometer to ensure that TCPP fluorescence can be correctly distinguished from the other fluorescent molecules that are part of the assay.
CyPath Lung uses automated flow cytometry and artificial intelligence to analyze patient samples by identifying parameters in sputum that are indicative of cancer. In a recent clinical trial, CyPath Lung showed 92% sensitivity and 87% specificity in high-risk patients who had nodules smaller than 20 millimeters or no nodules in the lung, with an area under the ROC curve of 94%.