SAN ANTONIO - bioAffinity Technologies' (NASDAQ:BIAF; BIAFW) Vice President of Diagnostics, Jennifer Rebeles, Ph.D., has contributed to a panel of global experts in publishing a peer-reviewed paper on flow cytometry testing of unique biological samples. The paper, titled "Implementation of flow cytometry testing on rare matrix samples: Special considerations and best practices when the sample is unique or difficult to obtain," appeared in the journal Cytometry Part B: Clinical Cytometry.
The paper addresses the challenges in validating assays with unique sample types, such as sputum, which is used in bioAffinity's CyPath® Lung test for early lung cancer detection. This test, which has demonstrated 92% sensitivity and 87% specificity, is especially useful for patients with pulmonary nodules measuring 20 millimeters or less.
Rebeles, along with 11 other experts from various sectors, aimed to expand the scope of the Clinical and Laboratory Standards Institute (CLSI) Guideline H62, a standard for flow cytometry assay validation issued in 2021. Their contributions are meant to support 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.
The new guidelines reflect the increasing use of specialized samples in flow cytometry and the need for customized protocols and optimization of cytometer settings. The updated guidelines also recognize the challenges faced by scientists in developing tests like CyPath® Lung, such as high sample viscosity and the presence of inhibitors.
CyPath® Lung uses advanced flow cytometry and artificial intelligence (AI) to identify cell populations indicative of malignancy in patient sputum. The test incorporates a fluorescent porphyrin selectively absorbed by cancerous cells, contributing to its high accuracy rates.
bioAffinity Technologies specializes in noninvasive diagnostics for early-stage cancer and diseases of the lung. The company's CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies.
This news article is based on a press release statement from bioAffinity Technologies, Inc.
In other recent news, bioAffinity Technologies has been making significant strides in its operations and strategy. The firm recently announced the appointment of 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. This decision was made during the 2024 Special Meeting of Stockholders, where stockholders voted in favor of two proposals.
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. As a result, bioAffinity has adjusted its 2024 sales forecast to exceed 880 CyPath® Lung tests, with its subsidiary, Precision Pathology Laboratory Services, expected to generate revenue between $9.2 and $9.6 million.
In terms of personnel, the company has strengthened its sales team with the hiring of new executives and plans for a broader market launch of CyPath® Lung in the fourth quarter of 2024. These are the recent developments at bioAffinity Technologies.
InvestingPro Insights
As bioAffinity Technologies (NASDAQ:BIAF) continues to make strides in the field of early lung cancer detection, investors may be interested in some key financial insights. According to InvestingPro data, the company's market capitalization stands at $26.71 million USD, reflecting its position as a small-cap player in the biotechnology sector.
Despite the promising developments in its CyPath® Lung test, bioAffinity Technologies is currently not profitable, with a negative P/E ratio of -3.06 for the last twelve months as of Q2 2024. This is not uncommon for early-stage biotech companies investing heavily in research and development. However, the company has shown impressive revenue growth, with a staggering 30,185.99% increase in the last twelve months as of Q2 2024, indicating significant commercial traction for its diagnostic technologies.
InvestingPro Tips highlight that analysts anticipate sales growth in the current year, which aligns with the company's recent scientific contributions and the potential market expansion for its CyPath® Lung test. However, it's worth noting that the company is quickly burning through cash, a common characteristic of biotech firms in the development and early commercialization phases.
The stock's price movements are quite volatile, which is reflected in its strong return of 14.45% over the last month, despite a -18.52% return over the past three months. This volatility may present both opportunities and risks for investors.
For those interested in a deeper analysis, InvestingPro offers 8 additional tips for bioAffinity Technologies, providing a more comprehensive view of the company's financial health and market position.
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