bioAffinity Technologies, Inc. is a biotechnology company focused on developing diagnostic and therapeutic solutions, primarily in the oncology field, including laboratory services like the CyPath Lung test for early lung cancer detection.

# Company Summary: bioAffinity Technologies, Inc.

**Overview**:
bioAffinity Technologies, Inc. is a biotechnology company focused on developing diagnostic and therapeutic solutions, primarily in the oncology field. The company is engaged in advancing breakthrough diagnostic assays and therapeutics aimed at improving early cancer detection.

**Business Focus**:
- Developing oncology-focused diagnostics using advanced molecular and cellular technologies.
- Offering laboratory services, including the CyPath® Lung test for early detection of lung cancer, which is marketed as a laboratory-developed test (LDT).
- Commercializing high-complexity molecular tests and in-vitro diagnostic tests (IVDs) utilizing proprietary platforms.
- Managing clinical laboratory operations through its subsidiary, PPLS, which acquired assets of Village Oaks Pathology Services to expand its clinical pathology offerings.

**Operations**:
- The company's operations encompass developing and commercializing diagnostic assays, clinical laboratory testing, and related services.
- The laboratory assets are CAP-accredited and CLIA-certified, indicating compliance with high standards for laboratory practices.

**Customer Base**:
- The company has offered the CyPath Lung test as an LDT since at least September 2021, serving physicians and healthcare providers involved in lung cancer screening.
- Specific number of customers or clients is not provided.

**Employees**:
- The company has at least 11 named executive officers and directors.
- The overall number of employees is not provided.

**Financial Data** (as of the latest available report):
- **Outstanding Shares**: 18,255,824 shares of common stock as of March 31, 2025.
- **Market Capitalization** (as of June 28, 2024): Approximately $22.6 million based on the stock’s closing price.
- **Revenue and Income**: No specific revenue, net income, or detailed financial figures are provided in the document.

**Additional Notes**:
- The company's executive team has extensive experience in medical, legal, and business management related to healthcare and environmental sectors.
- The company has engaged in various acquisitions and partnerships, including the purchase of laboratory assets and licensing agreements for proprietary technology platforms.

*Note: No specific data on total revenue, net income, total number of customers, or total employees is provided in the document. The summary reflects only the available detailed information from the provided filing.*

bioAffinity Technologies, Inc. is a leader in noninvasive diagnostics for early-stage lung cancer and other lung diseases, with a focus on innovative research and developing advanced therapeutic solutions.

# Company Overview: bioAffinity Technologies, Inc.

## Business Focus
bioAffinity Technologies, Inc. develops **noninvasive diagnostics** to detect **early-stage lung cancer** and other lung diseases. The company also conducts research into therapeutic discoveries that may lead to broad-spectrum cancer treatments in the future. Their primary product is **CyPath® Lung**, which analyzes cell populations in sputum to identify indicators of lung cancer using **flow cytometry** and **automated analysis powered by artificial intelligence (AI)**.

## Key Products
- **CyPath® Lung**: A noninvasive diagnostic test for early-stage lung cancer, designed to address the need for improved accuracy in lung cancer detection. 
  - **Technical Details**:
    - Uses flow cytometry to analyze sputum samples.
    - Detects cancer-related cells with over 16 million cells examined in about 30 minutes.
    - Achieved **82% sensitivity** and **88% specificity** in trials.
    - Recently assigned CPT code **0406U** for reimbursement under the Medicare Clinical Laboratory Fee Schedule effective January 1, 2024.

## Recent Developments
- Acquired **Village Oaks Pathology Services** to enhance laboratory capabilities.
- Announced **strategic partnerships** and **increased sales**, with a reported **375% growth** in CyPath® Lung tests ordered from December 2023 to February 2024.

## Financials
- **Revenue**:
  - For the year ended **December 31, 2023**: approximately **$2.5 million**.
  - Specific to laboratory patient services: **$2.2 million**.
- **Net Income**: Reported a net loss of **$7.9 million** for the year ending December 31, 2023.
- **Cash on Hand**: Approximately **$2.8 million** as of the same date.
- **Employees**: The company currently employs **75 employees**—22 at bioAffinity and 53 at **Precision Pathology Laboratory Services, LLC (PPLS)**. This includes award-winning scientists and clinicians, with expertise in pulmonary medicine and other relevant fields.

## Market Potential
- Has a strong foothold in the growing cancer diagnostics market, projected to grow from **$102.24 billion** in 2022 to **$162.57 billion** by 2030. 
- The specific market for lung cancer diagnostics is estimated at **$2.6 billion** in 2022 and expected to reach **$4.7 billion** by 2030.

## Customer Base
- CyPath® Lung primarily targets **physicians** and **patients** at high risk for lung cancer.
- Initiated sales to the **Department of Defense (DOD)** for research studies, expanding its potential customer reach.

## Competitive Advantage
- bioAffinity Technologies boasts a proprietary and innovative diagnostic platform that is **noninvasive, cost-effective**, and designed to enhance patient outcomes by providing quicker and more accurate diagnostics compared to traditional methods.  

In summary, bioAffinity Technologies, Inc. is positioned as a leader in the field of lung cancer diagnostics with its innovative approach through noninvasive testing and a robust research and development pipeline aimed at improving patient care and outcomes in the oncology sector.

bioAffinity Technologies, Inc.

10-K / April 29, 2025

10-K / April 1, 2024

10-K / April 29, 2025

Company Summary: bioAffinity Technologies, Inc.