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Novel Platform Technology Made a Reality Through InfinixBio’s Rapid Development

A virtual biotech firm partnered with InfinixBio’s team to deliver a functional development of a novel clinical diagnostic test to analyze bacterial pathogens.

During a recent collaboration with a client, our team was tasked with helping obtain FDA approval for a novel platform technology that analyzes bacterial pathogens derived from human clinical samples via clinical diagnostic tests. As a virtual company, our client lacked the internal capabilities and experience required to safely handle and culture a range of Gram-negative and Gram-positive bacterial pathogens within a Biosafety Level 2 facility.

To demonstrate a functional, user-friendly, sensitive, and reproducible analytical process for the FDA, we called upon decades of hands-on skill performing sophisticated biochemical methods for protein labeling, analytical instrumentation, and the precise quantitative measurement of test samples. Though the testing process was complex, our flexible, adaptable team overcame all challenges, responded to a rapidly evolving system, and efficiently worked with additional development partners in pursuit of FDA approval for the client’s innovative novel platform technology.