Case Study #4

RUO Transitioning into the IVD Market

Neozene was approached by a diagnostics company with a portfolio of Research Use Only (RUO) products. The company’s goal was to have their devices FDA cleared for commercial use in order to take advantage of the emerging market of personalized medicine.

Business challenge: The company was not sure of the regulatory requirements that would govern their RUO products in the commercial market. They needed a high level Advisor to help them structure and prepare their Reagent Manufacturing Operations to be in compliance with the FDA regulations and also prepare for future growth.

Proposed Solutions: Neozene performed a comprehensive Gap Assessment of their existing systems and developed a their strategic pathway. The results of the Gap Assessment indicated that significant modifications were required since very little existed in the way of Design History Records or Standard Operating Procedures in the company. The following steps were proposed:

• Create and implement the reagent operational processes including all operational documentation
• Facilitate the purchase of the necessary equipment to bring Operations consistent with industry best practices
• Define an infrastructure strategy that would enable future growth and sustainably transition from manual to automated processes
• Train existing personnel on cGMP and applicable regulations and requirements

Results/Value Delivered: The company embraced the proposal and engaged Neozene to deliver this solution. The plan was implemented over a period of 10 months and laid the groundwork for their first commercial IVD product. Neozene was also able to help the company identify and locate some used equipment at a significant cost savings.