SAN ANTONIO - bioAffinity Technologies, Inc. (NASDAQ:BIAF; BIAFW) has been granted a Japanese patent for its CyPath® Lung test, a noninvasive diagnostic method for early-stage lung cancer detection. The patent, titled "System and Method for Determining the State of Health of the Lungs," marks the first in Japan for the company's flow cytometry-based assay.
The addition to bioAffinity's intellectual property portfolio, now comprising 17 U.S. and international patents with 30 pending applications, is a strategic move to protect its proprietary technology. The CyPath® Lung test employs advanced flow cytometry and artificial intelligence to analyze patient sputum samples for malignancy indicators, achieving 92% sensitivity, 87% specificity, and 88% accuracy in clinical studies.
Maria Zannes, President and CEO of bioAffinity, emphasized the significance of the Japanese patent for the company's global strategy. Zannes expressed anticipation for further patents in additional regions and highlighted the potential for CyPath® Lung to improve patient outcomes through earlier detection.
The company's focus remains on expanding its diagnostic and therapeutic research to address early-stage cancer and other lung diseases. CyPath® Lung is currently marketed as a Laboratory Developed Test by Precision Pathology Laboratory Services, a bioAffinity subsidiary.
This news is based on a press release statement and does not constitute an endorsement of the company or its claims. The forward-looking statements within the press release are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially.
In other recent news, bioAffinity Technologies has been making significant strides in its operations and strategy. The firm recently appointed J. Michael Edwards as its Chief Financial Officer. Edwards, who brings over thirty years of financial management and business strategy experience, previously served as interim CFO and played a key role in the company's initial public offering in 2022.
In another development, bioAffinity Technologies secured approval from its shareholders for the issuance of up to 1,801,944 shares of common stock upon the exercise of warrants. The company has also seen a significant 85% rise in its full-year sales projection for the CyPath® Lung test, following a 217% growth in second-quarter sales. This growth is largely attributed to the expansion of the company's customer base among pulmonology practices, particularly in Texas.
Additionally, Jennifer Rebeles, Ph.D., Vice President of Diagnostics at bioAffinity Technologies, contributed to a panel of global experts in publishing a peer-reviewed paper on flow cytometry testing. This paper supports the validation of rare matrices like sputum in clinical flow cytometry, a field where bioAffinity Technologies has been actively developing its noninvasive CyPath® Lung assay.
These are the recent developments at bioAffinity Technologies.
InvestingPro Insights
As bioAffinity Technologies (NASDAQ:BIAF) secures its first Japanese patent for the CyPath® Lung test, investors may find additional context from InvestingPro's real-time data and tips particularly illuminating.
Despite the positive news on patent acquisition, InvestingPro data reveals that BIAF is currently trading near its 52-week low, with the stock price down 37.5% over the past month. This suggests that the market has yet to fully price in the potential value of the company's expanding intellectual property portfolio.
An InvestingPro Tip indicates that analysts anticipate sales growth for BIAF in the current year, which aligns with the company's strategic moves to commercialize its CyPath® Lung test. However, it's worth noting that the company is not expected to be profitable this year, according to another InvestingPro Tip.
The company's revenue growth is striking, with InvestingPro data showing a 30,185.99% increase over the last twelve months as of Q2 2024. This extraordinary growth rate could be attributed to the initial commercialization efforts of the CyPath® Lung test, though investors should be aware that such high growth rates are often not sustainable in the long term.
For those interested in a deeper analysis, InvestingPro offers 12 additional tips for BIAF, providing a more comprehensive view of the company's financial health and market position.
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