madman
Super Moderator
Diagnostics company opens new facility to scale up production of IsoPSA test for prostate cancer
The new space includes a clinical laboratory for IsoPSA testing, labs for research and development, offices, and manufacturing spaces for production and distribution of in vitro diagnostic kits.
The non-invasive IsoPSA blood test assesses high-grade prostate cancer likelihood before or after a biopsy. Recently included in National Comprehensive Cancer Network guidelines for early detection. A real-world study on 734 patients aged 50+ with PSA levels between 4-100 ng/mL and no history of prostate cancer showed a 55% reduction in biopsy recommendations and a 9% reduction in MRI imaging with IsoPSA. High concordance between physician recommendations and IsoPSA results. IsoPSA has FDA Breakthrough Therapy designation and awaits FDA premarket approval.
