South Korean point-of-care testing device manufacturer NanoEnTek announced on January 18 that it obtained an FDA approval for its FREND Vitamin D, with which blood vitamin D concentration can be measured within 20 minutes. According to market research firms, the global vitamin D test kit market is expected to grow from US$540 million to US$2.19 billion between 2013 and 2018. At present, the concentration measurement takes approximately a week at clinical laboratories. With the FREND Vitamin D, however, it can be carried out within 20 minutes even at neighborhood clinics.
“Vitamin D has a small molecular size and the measurement by the use of a point-of-care test kit is not easy for its structural complexity,” said NanoEnTek CTO Jeong Chan-il, adding, “This is why only one product other than ours has succeeded in obtaining the FDA approval.” He went on to say, “We are planning to supply our product via our marketing networks across the United States based on a contract with McKesson, the largest medical equipment distributor in the country.”
NanoEnTek’s FREND products are point-of-care testing systems that allow lab experiments to be carried out inside a small chip by means of a combination between microelectromechanical system technology and microfluidics and biotechnology. These products are used with different cartridges for various tests. Up to this moment, the company has obtained four FDA approvals for its FREND products for prostate glands, thyroid glands, etc.