🌍 CorDx Fertility Tests: Empowering Global Family Planning As a leader in in vitro diagnostics (IVD), CorDx is committed to democratising health information, beginning with crucial reproductive health insights. Our comprehensive line of fertility tests is developed using an end-to-end integrated approach, ensuring quality, affordability, and accessibility for patients and healthcare professionals worldwide.
🔬 The Science of Diagnostics: How CorDx Tests Work CorDx leverages cutting-edge IVD techniques, primarily Lateral Flow Immunoassays (LFIAs), to create rapid, highly sensitive, and userfriendly fertility tests. This technology forms the foundation of our product portfolio, which includes:
HCG Pregnancy Tests (Strip, Cassette, Midstream): Utilising colloidal gold technology to detect Human Chorionic Gonadotropin (HCG) in urine at various sensitivities (e.g., 25mIU/ml, 20mIU/ml, 10mIU/ml) for early and accurate pregnancy detection
LH Ovulation Tests (Cassette, Midstream): Designed to pinpoint a woman's most fertile window by detecting the surge of Luteinising Hormone (LH) in urine, also at multiple sensitivities (e.g., 25mIU/ml, 20mIU/ml).
Combination Tests (HCG + LH): Providing an all-in-one solution for family planning by simultaneously testing for both HCG and LH markers on a single platform.
FSH Tests (Follicle-Stimulating Hormone): Offering insights into ovarian reserve and menopausal transition.
This variety of formats (Strip, Cassette, Midstream) and customisable sensitivities allows us to serve diverse market needs, from professional clinic settings to convenient at-home self-testing.
🏭 The CorDx Advantage: Vertical Integration for Global Impact Our ability to deliver high-quality, cost-effective diagnostics globally is rooted in our vertically integrated supply chain. This means CorDx owns and controls every step of the process—from sourcing raw materials like antibodies and plastic cassettes to final manufacturing and distribution.
This complete control ensures:
Unparalleled Quality Control: We maintain robust Quality Management Systems (QMS) across all stages, with facilities operating in compliance with international standards (e.g., ISO 13485:2016 and GMP).
Guaranteed Accessibility: Our global manufacturing and distribution footprint, with operations in the United States, China, and Singapore (APAC Headquarters), provides a resilient and agile supply chain. This guarantees that diagnostics reach our partners and users anywhere in the world, addressing critical global health needs.
Affordability: By eliminating external supplier costs, we pass on savings, making essential reproductive health monitoring tools affordable for more individuals.
✅ Regulatory Excellence: Trusted Worldwide Trust and compliance are paramount. Our products are developed and manufactured to meet the stringent requirements of leading regulatory bodies, confirming their safety and effectiveness for global markets:
US Approval: Products, including the LH Ovulation Tests, carry the FDA 510(k) Exempt status, recognizing their low-to-moderate risk profile and compliance with essential safety and performance requirements for the US market.
European Approval: All relevant products bear the CE 0197 Mark, demonstrating conformity with the health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).
By merging advanced diagnostic technology with a fully integrated, quality-driven supply chain and achieving global regulatory compliance, CorDx is effectively transforming the landscape of fertility testing, putting reliable reproductive health information directly into the hands of those who need it most.