Qualigen Receives FDA Clearance for its FastPack® IP SHBG Assay

Posted on Jan 29, 19 in News

Qualigen, Inc., a privately-owned company that provides novel diagnostic and therapeutic technologies for the treatment of cancer and infectious diseases, today announced that the Company has received clearance from the U.S. Food and Drug Administration for its FastPack IP Sex Hormone Binding Globulin (SHBG) Immunoassay.  Sex Hormone Binding Globulin is an important biomarker used in the diagnosis and treatment of men’s health.  “FastPack IP SHBG provides rapid, fully-quantitative and highly accurate Sex Hormone Binding Globulin results to clinicians and patients,” stated Dr. Wajdi Abdul-Ahad, Qualigen’s Vice President of Assay Development, whose team developed this assay.  “We are pleased to continue the expansion of our novel FastPack product line and to provide additional diagnostic tools to our physicians and their patients,” added Michael S. Poirier, Chief Executive Officer of Qualigen.