Company: APXIF
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065703
Chunk: 387

Company: APx Acquisition Corp. I
Filing Date: 2025-07-18
Form: F-4/A
Chunk 387
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 continue be, subject to laws and regulations of the countries where we operate, which include laws and regulations governing biotechnology and precision medicine companies related to the development, approval, processing, import, export, marketing and sale of our products. Regulations Applicable to our Laboratory Operations We uphold the highest standards in our laboratory operations, as evidenced by the quality certifications we have obtained by CAP, EMQN, and UKNEQAS for our Argentina facility. For our Heritas services, we have obtained certification from the CAP that ensures that our Non -InvasivePrenatal, Clinical Exome, and CMA tests meet the global standard of laboratory quality assurance, reflecting our commitment to excellence and patient care. In addition, we have accreditation from EMQN and the United Kingdom National External Quality Assessment Service (“UKNEQAS”) to oversee our Hereditary Cancer testing protocols, offering an external quality assessment that guarantees our tests’ standards, as well as precision and diagnostic reliability. These certifications from CAP, EMQN, and UKNEQAS exemplify Heritas Diagnostics’ dedication to quality, which is foundational to our operations and instrumental to provide global quality services to patients and healthcare providers alike. It is important to note that if our laboratory is found to be out of compliance with the requirements to uphold these certifications, we may be subject to sanctions and suspension, limitation, or revocation of the CAP, UKNEQAS and EMQN certificates. As such, we maintain the highest standards to comply with all requirements. We are subject to survey and inspection every year to assess compliance with CAP’s and EMQN’s program standards, and we may be subject to additional unannounced inspections. Additionally, our laboratory operations, for both Rewell and Heritas Diagnostics’ products, are certified under the ISO 9001:2015 standard, a testament to commitment to quality management. This certification underscores our commitment to consistent, high -qualityprocesses and procedures that enhance customer satisfaction and operational efficiency. It is an integral part of our quality assurance program, ensuring that every aspect of our service adheres to international best practices and continual improvement strategies. This ISO certification, which is also subject to survey and inspection every year, aligns with our overarching mission to deliver exceptional genetic testing services and to foster trust and reliability in the global healthcare landscape. 193 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