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Qualigen Receives FDA Clearance for its FastPack® IP SHBG Assay

CARLSBAD, Calif., Jan. 29, 2019 /PRNewswire/ -- 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.

About Qualigen, Inc.
Qualigen, Inc. is a medical device company focused on the development, production and commercialization of innovative medical technologies, including its flagship FastPack® point-of-care immunoassay system and novel therapeutic technologies for treatment of cancers and infectious diseases.  For more information, visit

© 2019 Qualigen. All rights reserved. Qualigen, the stylized logo, and FastPack are registered trademarks of Qualigen, Incorporated in the United States and other countries.

SOURCE Qualigen, Inc.

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Last Updated: 31-Jan-2019