About Us
Company Overview
Founded in 2016, Bionostix is an in-vitro diagnostics (IVD) manufacturer and development partner focused on the reliable production of diagnostic reagents for routine and specialized laboratory use.
Headquartered and incorporated in Egypt, with manufacturing operations located in Badr City near Cairo, Bionostix operates dedicated production facilities under a structured quality management system to support regulated diagnostic markets.
With a workforce of more than 150 employees, the company combines scientific expertise, industrial manufacturing capability, and operational scale to deliver consistent, high-quality diagnostic products.
Scientific Leadership
Bionostix was founded by Prof. Alaa Barakat, a university professor and the company’s Chief Executive Officer.
Prof. Barakat's academic background in biotechnology and biochemistry has shaped Bionostix’s emphasis on scientific rigor, controlled processes, and methodical product development. Under his leadership, the company has grown from an early-stage operation into a structured manufacturing organization serving international diagnostic supply chains.
Bionostix develops and manufactures in-vitro diagnostic reagents across multiple application areas, including immunoassays, hematology reagents, urine diagnostics, and analytical chemistry–based solutions.
The company operates as both a manufacturer and development partner, supporting legal manufacturers and distribution partners through formulation development, process optimization, and controlled production under an ISO 13485–certified quality management system.
Bionostix’s role is focused on transforming diagnostic concepts into reproducible, scalable manufacturing processes suitable for routine laboratory use.
What We Do
Regulatory and Manufacturing Role
Bionostix manufactures in-vitro diagnostic products in alignment with applicable regulatory requirements and acts as an approved manufacturing site for selected CE-marked products under the In Vitro Diagnostic Directive (IVDD), where the legal manufacturer holds market responsibility.
This manufacturing-focused role allows Bionostix to support regulated market supply while maintaining clear separation between production activities and legal manufacturer obligations.
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Today, Bionostix’s core activities are centered on IVD manufacturing and development support. Building on this foundation, the company continues to strengthen its technical capabilities and production infrastructure in line with evolving regulatory standards and long-term diagnostic market needs.