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1 the in vitro diagnostic kit was approved through the premarket approval process.

The blood test helps patients avoid unnecessary and invasive biopsies 1 the approval occurred through the premarket approval process Notably, isopsa in vitro diagnostics kit utilizes the isoclear. This in vitro diagnostic (ivd) kit analyzes psa protein structure to assess prostate cancer risk, aiming to prevent up to 75% of unnecessary prostate biopsies Food and drug administration (fda) has approved the company’s isopsa® in vitro diagnostic (ivd) kit.