Qualigen, Inc., a privately owned company that provides rapid, easy to use, fully quantitative diagnostic testing solutions, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its FastPack Vitamin D Immunoassay for use on its proprietary FastPack System for the rapid determination of vitamin D status. FastPack Vitamin D test results are available in 10 minutes, providing a significant benefit to clinicians and patients. Numerous studies have shown a high global prevalence of vitamin D insufficiency and the measurement of vitamin D status provides opportunities for preventive and therapeutic interventions. Insufficient vitamin D levels are a cause of secondary hyperparathyroidism and diseases resulting in impaired bone metabolism (like rickets, osteoporosis, osteomalacia) and have been associated with an increasing risk of many chronic diseases, including common cancers, autoimmune or infectious diseases or cardiovascular problems. In terms of market size, in 2013, the number of vitamin D tests performed worldwide is estimated to be greater than 100 million. By 2015, this number is expected to reach almost 140 million tests.
"We are confident that our FastPack Vitamin D Immunoassay will provide customers with a rapid, highly accurate and easy to use solution for the assessment of vitamin D status in their patients and will generate significantly increased utilization of the FastPack System throughout our installed base of FastPack Analyzers," said Paul Rosinack, president and chief executive officer of Qualigen, Inc. "In addition, we expect the introduction of this new test to drive an increase in new FastPack System placements worldwide."
The FastPack System is the only fully-quantitative immunoassay system which features one-touch operation and provides high quality test results in 10 minutes or less, depending upon the assay. This patented technology platform combines a novel analyzer and pouch-based disposable with powerful monoclonal antibody, magnetic particle chemiluminescence to provide test results that are highly sensitive, accurate and precise. The addition of Vitamin D expands the FastPack menu to eight assays: Prostate Specific Antigen (PSA), free PSA (FPSA), Testosterone, Thyroid Stimulating Hormone (TSH), free Thyroxine (FT4), Human Chorionic Gonadotropin (hCG), Alpha GST and Vitamin D.
The 510(k) clearance allows Qualigen to market and sell its new FastPack Vitamin D Immunoassay in the United States. In addition, the FastPack Vitamin D Immunoassay is CE Marked for sale in the EU.