CORRECTED-TearLab gets FDA nod for wider use of eye test
[Corrects story posted Dec 5, 2011as 20111205elin012. Corrects headline and text to show that the TearLab test was approved for wider professional use, not home use. Adds comments from company and analyst]
(Reuters) - TearLab Corp said U.S. health regulators granted a waiver that allowed for the wider use of its device to diagnose dry eye, sending the medical device maker's shares up as much as 80 percent to their highest in eight months.
The U.S. Food and Drug Administration granted a Clinical Laboratory Improvement Amendments (CLlA) waiver to the company's TearLab Osmolarity System, based on a supervisory review.
The waiver was granted after the regulator classified the test as "simple," from "moderately complex" earlier, a company spokesman told Reuters by phone.
Dry eye disease is a condition in which the eye does not produce enough tears to keep its surface sufficiently lubricated.
It affects about 40 million people in the United States and 100 million people worldwide, the company said.
"Without a CLIA waiver, an eye practice would need to obtain CLIA certification through paperwork and a 20-hour CME course, as well as maintain this certification through ongoing requirements," Roth Capital analyst Matt Dolan wrote in a note to clients.
"Our feedback from the field indicated that the CLIA certification process has been a significant impediment to adoption of the TearLab Osmolarity System."
Shares of the San Diego, California-based company were trading up 13 percent at $1.41, after touching a high of $2.25 earlier in the day.
