NEXT GENERATION SEQUENCING PANEL FOR FAMILIAL HYPERCHOLESTEROLEMIA AND WHOLE EXOME SEQUENCING LIBRARY PREP SOLUTION

The required Next Generation Sequencing (NGS) panel incorporates proprietary design, content and associated intellectual property rights that are owned and controlled exclusively by the supplier. No other economic operator is authorised to manufacture, supply, licence or support the specific panel required. The intellectual property protections and exclusive rights prevent equivalent products from being supplied by alternative providers.

The required solution has been extensively validated within the existing diagnostic pathway and is fully compatible with current laboratory equipment, workflows and reporting processes. No alternative supplier can provide an equivalent validated solution without significant revalidation, implementation effort and associated costs. Introducing an alternative product would require extensive analytical and clinical validation, resulting in delays to service delivery, additional resource requirements and potential risks to continuity of patient testing. The technical characteristics, proven performance and integration requirements mean that competition is absent for technical reasons.