Company: APXIF
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065703
Chunk: 388

Company: APx Acquisition Corp. I
Filing Date: 2025-07-18
Form: F-4/A
Chunk 388
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 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. Specifically, in Argentina and Mexico, the responsible professional must be a licensed biochemist, who is authorized to sign -offon laboratory results from LDTs, ensuring compliance with local professional and healthcare regulations. The Company, 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. As of the date of this Registration Statement of which this prospectus forms part, there are no regulatory approvals for LDTs required by Argentine and Mexican law, and we have not sought any such approvals. 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. The only applicable regulation pertains to laboratories, which might comply with operational standards. 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 most countries in Latin America, the ISO 15189:2012 standard is used as a reference for clinical laboratory accreditation; however, compliance with this standard is not mandatory in any of them. To differentiate the value of our LDTs, the objective will be to accredit the tests that we introduce to the market under this standard. While certification is not required in the countries where these products will be marketed, obtaining international accreditation strengthens the validity and quality of their development, even in the absence of a legal framework requiring it. In summary, while LDTs in these countries, as well as in