TearLab gets FDA nod for home use of dry eye test
(Reuters) - TearLab Corp said health regulators allowed home use of its device to diagnose dry eye condition, 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 Clinical Laboratory Improvement Amendments (CLlA) waiver to the company's TearLab Osmolarity System, based on a supervisory review.
CLlA waivers are granted to simple tests that have little chance of going wrong and can be performed at home.
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.
Shares of the San Diego, California-based company were up 54 percent at $1.91, making them one of the top gainers on Nasdaq. They had earlier touched a high of $2.25 in heavy morning trade.
