BioAffinity secures $2.7M to advance novel lung cancer diagnostic test | LabPulse.com

Texas-based bioAffinity Technologies has secured nearly $2.7 million at the close of a registered direct stock offering that it will use for general corporate purposes, including working capital, to advance its novel CyPath Lung test, according to a press release it issued on October 21.

CyPath Lung is designed to be a noninvasive early-stage lung cancer detection test. It uses flow cytometry and artificial intelligence (AI) to identify cell populations in sputum samples that indicate malignancy, according to bioAffinity. Automated data analysis assists in determining whether cancer is present or not. CyPath Lung is marketed as a laboratory-developed test (LDT).

Earlier this month, bioAffinity celebrated the peer-reviewed paper "Implementation of Flow Cytometry Testing on Rare Matrix Samples: Special Considerations and Best Practices When the Sample Is Unique or Difficult to Obtain," which was published on July 20 in the journal Cytometry Part B: Clinical Cytometry.

The paper supplements the Clinical and Laboratory Standards Institute Guideline H62, the standard for validating assays performed by flow cytometry issued in 2021, by addressing challenges and considerations in validating unique sample types, according to bioAffinity.

"The new guidelines support the way we have validated the CyPath Lung assay in our own laboratory, including customized protocols, specialized reagents, optimized cytometer settings and unique gating strategies," said bioAffinity Vice President of Diagnostics Jennifer Rebeles, PhD, who with an international group from academic pathology and commercial bioanalytical and other laboratories, wrote the paper.

Additionally, the paper offers a much-needed foundation for the validation of flow cytometric assays requiring special considerations, according to the authors, who acknowledged that the field is constantly evolving with ongoing discussion among experts.

Precision Pathology Services, a provider of pathology services to physicians practicing in a variety of outpatient settings, offers CyPath Lung as an LDT. BioAffinity acquired Precision Pathology's lab assets from Village Oaks Pathology Services in September 2023 for its laboratory infrastructure and to support a pivotal clinical trial using the test.

CyPath Lung has expanded into New Jersey, Ohio, Pennsylvania, Michigan, North Carolina, California, Florida, and Arizona, Precision Pathology noted in June.