Company: BGLC
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001477932-25-002725
Chunk: 95

Company: BioNexus Gene Lab Corp
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 95
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 states.

These expression profiles, or molecular signatures, serve as the foundation for our diagnostic assays. By identifying disease-specific gene activity patterns, we can develop screening tools that enable early detection, monitor disease progression, and support precision interventions.

We take advantage of profiling these changes, which enables us to identify unique molecular signatures (biomarkers) reflecting disease activity which can then be used to develop disease-specific molecular diagnostic assays. We use these biomarkers as the basis for screening tests for early disease detection and generate revenue from providing screening services.

The Screening Process

Our screening process begins with a blood sample. While we do not perform direct sample collection, a licensed healthcare provider draws approximately 2.5 ml of blood from the patient using a PAXgene™ tube. The sample, along with a completed Blood Withdrawal Card, is securely delivered to our laboratory via certified courier.

Upon arrival:

 ·Samples are labeled with the patient’s name, ID number, and lab reference code. ·RNA is extracted in a biosafety cabinet, then processed using microcentrifugation and spectrophotometry to assess quality and concentration. ·RNA is purified, biotinylated, hybridized onto a GeneChip™ microarray, and analyzed using proprietary software to generate a personalized risk score report.

Our reports are delivered to the referring healthcare provider for clinical use. These include a disease risk chart and interpretations intended to aid further diagnostics and therapeutic planning.

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The process for effectuating RNA analysis depicted in the picture below.

The raw data obtained will be analyzed and quality control processed by our lab in Malaysia using proprietary software to calculate the risk analysis of 11 different diseases. We simplify the result into a graph which is contained in the patient booklet provided to the health care professional. A sample graph is depicted below.

In the above chart, NPC is Nasopharyngeal Cancer, ATDS is Ascending, Transverse, Descending, and Sigmoid Colon Cancer, and OA is Osteoarthritis.

The following cautionary text is contained in the results booklet we provide to the healthcare provider and each patient. The results booklet contains recommendations to assist with a physician's final diagnosis and treatment plan and is not meant to be medical advice. Below is the disclaimer that is included in each result booklet.

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This report/screening is not intended or implied as a substitute for professional medical advice, diagnostics, or treatment. The content, including text, graphics, and information in the report, illustrates the risk