1 the in vitro diagnostic kit was approved through the premarket approval process. Food and drug administration (fda) has approved the company’s isopsa® in vitro diagnostic (ivd) kit. The blood test helps patients avoid unnecessary and invasive biopsies
1 the approval occurred through the premarket approval process 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 Notably, isopsa in vitro diagnostics kit utilizes the isoclear.
