San Diego Business Journal

Qualigen Inc. Receives FDA Clearance for FastPack Vitamin D Immunoassay

Wednesday, July 17, 2013

Carlsbad-based diagnostic test maker Qualigen Inc. announced that it has received U.S. Food and Drug Administration clearance for its FastPack Vitamin D Immunoassay, which can rapidly detect levels of the key vitamin in a patient’s bloodstream.

The test can determine vitamin D levels in 10 minutes, which could have significant clinical impact on patients, the company said.

Vitamin D deficiency leads to diseases like rickets and osteoporosis. More than 100 million tests of vitamin D are performed worldwide, the company said, and it is expected to reach 140 million by 2015.

The new vitamin D diagnostic will be incorporated into a suite of blood tests from Qualigen called the FastPack IP System, which can be used to measure thyroid and urologic function.

There are several vitamin D tests on the market, according to a 2012 study from Maywood, Ill.-based Loyola University Stritch School of Medicine. The tests are becoming one of the most-prescribed by doctors, the study found. However, it found that two of the most recent market contenders were quite often inaccurate.

“Inaccurate results obtained from vitamin D blood tests could lead to misdiagnoses of patients,” said Earle Holmes, lead author of the study, at last year’s annual meeting of the Endocrine Society in Houston. “These inaccuracies also could confound efforts to identify the optimal levels of vitamin D for good health.”

— Meghana Keshavan