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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.

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