The U.S. Food and Drug Administration (FDA) has given the green light for the finger-prick blood test for Herpes Simplex Virus 1 (HSV-1) developed by startup company Theranos Inc.
The company announced on Thursday, July 2, that they have received the approval letter and, according to them, this serves as a validation of their technology and approach to affordable blood testing that requires little amount of patient discomfort.
The FDA comprehensively reviewed the system proposed by Theranos, which involved the highly computerized medium that aims to lessen human errors linked to the processing of the specimens. In the approval issued by the FDA, the use of the Theranos' Nanotainer was also given the go signal. Through this tube, blood samples may be drawn with very minimal pain because only a few drops of blood from the patient's finger are required for testing. The entire Theranos system, including its analytical software and other devices, has been cleared for use.
Theranos has received numerous disapprovals from academic experts, citing the elusiveness of the company's methods of technology. These researchers particularly emphasized that the essential data of how the company works in comparison to others have not been explained.
Despite the statements of critics, the studies presented by Theranos, which involved 818 study participants, claim that the finger-prick test of either whole blood or plasma for HSV-1 developed by their company can be comparable, or at least be as reliable as the traditional venipuncture procedure approved by the FDA.
"We are proud to have received our first FDA clearance," said Elizabeth Holmes, founder and CEO of Theranos. "In order to realize our vision of early detection, lab tests must meet the highest quality standards—standards that are comprehensively set by FDA."
According to Holmes, the process of approval that the FDA conducts is rigorous, and the company voluntarily decided to undergo it because it believes that the laboratory testing the FDA has developed is of the highest quality. In the commitment to guarantee health care providers and patients have access to correct health data, the company is hoping to continue its strong ties with the FDA for future endeavors, she added.
The HSV-1 test developed by Theranos retails for about $9.07, which makes it one of 100 products that Theranos sells for less than $10. Holmes says the traditional HSV-1 kit costs around $175. The tests are presently available at 42 branches of Walgreens in Arizona and one in California.
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