Company: APXIF
Filing Date: 2025-01-22
Form Type: F-4
Source: 0001213900-25-005463
Chunk: 367

Company: APx Acquisition Corp. I
Filing Date: 2025-01-22
Form: F-4
Chunk 367
---
 mission to deliver exceptional genetic testing services and to foster trust and reliability in the global healthcare landscape. 190 Regulations Applicable to our Products and Services Rewell and Heritas Diagnostics Tests We have developed our products as LDTs, which are a type of in vitro diagnostic test that is designed, manufactured, and used within a laboratory. LDTs are developed under the complexity and uniqueness of a laboratory’s specific needs, which allows us to offer tests with unique conditions, develop tests using new technologies, or respond to market health needs that traditional commercial tests do not address. All our products and services fall under the category of LDTs, reflecting our capacity to develop specialized diagnostics tailored to the unique needs of our customers. These proprietary tests are a cornerstone of our service offering, enabling us to deliver personalized insights into individual health concerns, particularly in areas where commercial testing options are limited or non -existent. Responsibility for ensuring compliance with legal standards lies with the laboratory conducting the test and the authorized professionals signing the results. OmnigenicsAI, in turn, guarantees that each partner laboratory complies with the necessary legal authorizations, including facility and professional certifications, to perform these tests in accordance with local regulations. In Argentina, Mexico, and Paraguay, our main target markets in the short -term, regulatory oversight of LDTs varies but generally does not require specific regulatory approval processes as required in the United States and the European Union. In Argentina, LDTs are regulated under general clinical laboratory standards rather than a specific regulatory framework, placing responsibility on laboratories and professionals for quality and reliability. In Mexico, LDTs used solely within laboratory settings are governed by general health regulations without requiring formal approval, while in Paraguay, similar general health regulations apply, with laboratories accountable for quality and compliance. In summary, while LDTs in these countries, as well as in Latin America in general, are not subject to specific regulatory approval processes, laboratories are expected to maintain high standards of practice, ensure the competence of their personnel, and comply with general health regulations. Laboratories within our consortium are required to meet these standards, adhering to rigorous quality practices, maintaining the appropriate legal authorizations, and demonstrating the professional qualifications necessary to deliver reliable LDTs across diverse markets. Our commitment to excellence in LDTs ensures that all our products and services provide the most accurate results, providing our customers with the most precise and relevant information for their healthcare and lifestyle decisions. Telemedicine Services Our telemedicine services will be subject to the regulatory framework within each country where we operate.