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News 2023-07-06

Gradientech starts pre-clinical testing in the US

Gradientech has finalised the design of the first iteration of the gram-negative panel destined for the US market, and expects the initiation of the US regulatory (FDA) clinical evaluations during next year.

While we continue the preparations for the FDA clinical studies using the dedicated US gram-negative panel, we are very pleased to start pre-clinical testing at two reputable US clinical laboratories with the European GN panel. Both laboratories have ample experience in evaluating promising, early-access technologies in clinical microbiology, and results generated will be a strong indicator that the product will meet US expectations.

Link to press release