Company: APXIF
Filing Date: 2025-06-13
Form Type: F-4/A
Source: 0001213900-25-054324
Chunk: 388

Company: APx Acquisition Corp. I
Filing Date: 2025-06-13
Form: F-4/A
Chunk 388
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 with the most stringent standards applicable, ensuring robust protection of our customers’ privacy and the security of their data across all jurisdictions. This commitment is integral to our operational ethos and is critical to maintaining the trust and confidence of our customers worldwide. Clinical Trials To validate the sensitivity and specificity of our genomic tests, we conducted clinical studies under GCP guidelines to ensure scientific credibility and data reliability. Adhering to GCP standards safeguards participant rights, safety, and data confidentiality, supporting regulatory approval by demonstrating rigorous, ethical research methodologies. This approach facilitates the integration of genomic diagnostics into clinical practice while building trust among patients, healthcare providers, and regulatory bodies, thereby accelerating the acceptance and integration of genomic diagnostics into clinical practice. Each country has different regulations about how to generate data and validate the accuracy of a genetic diagnostic test. By applying the highest international standards in our clinical studies, we strive to ensure that we can use the information irrespective of borders. If necessary, we gather local data to validate genomic backgrounds and environmental conditions. Cardiovascular Disease Polygenic Risk Score (PRS) Study A cross -sectionalstudy was conducted from June 2022 to October 2023, sponsored by our subsidiary, Heritas Argentina and in collaboration with Hospital Italiano de Rosario. Principal Investigator (P.I.): M.D. Anibal Gentiletti. Approved by the hospital’s ethics committee, the study involved 155 participants aged 30 -85, divided into cases and controls: •Cases (n=39): Individuals with a CAD diagnosis. •Controls (n=111): Individuals without a CAD diagnosis, family history, or associated clinical risk factors. Each participant’s genetic material was purified from a saliva sample and analyzed using low -coveragewhole -genomesequencing with our imputation platform, calculating the PRS from approximately 1.7 million markers. Results showed a statistically significant difference between cases and controls (p -value: 0.000288), with higher PRS values associated with increased risk. The area under the curve (AUC) was 0.767, indicating moderate -to -highpredictive capacity Breast Cancer PRS Study Another cross -sectionalstudy, conducted from September 2021 to October 2023, was sponsored by Heritas Argentina in collaboration with Centro de Mastología Rosario. P.I.: M.D. Gonzalo Tabares. Approved by Comité de Etica Caici -Ciap, Rosario, Argentina, the study included female participants aged 45 – 65: •Cases (