Avellino Lab USA launches first genetic test for Avellino Corneal Dystrophy

March 29, 2013

Avellino Lab USA, developer of the first genetic test for Avellino Corneal Dystrophy (ACD), announced the launch of its Menlo Park, Calif.-based diagnostic laboratory and the availability of the Avellino-GENE Detection System (AGDS) Test in the United States.

Avellino Lab USA is the first to create a genetic test for ACD, a disease that develops slowly in the eye causing cloudiness at the center of the corneas that could lead to impaired vision or blindness. Carriers of ACD are at an extreme risk of experiencing eventual blindness should they undergo vision correction surgery, such as LASIK, LASEK or PRK.

While there is no treatment for ACD, Avellino Lab USA’s AGDS Test is able to detect the presence of the ACD gene mutation allowing the patient to take precautionary steps to potentially postpone the progression of the condition. Specifically, with the test results in hand, patients and their physicians can make an informed decision on whether or not to proceed with vision correction surgery.

A rare genetic mutation, ACD is found in an estimated one out of every 870 individuals, according to published research.

“Since 2008, more than 330,000 individuals have been tested with the AGDS Test outside the U.S., as the standard of care in Korea and Japan, identifying 301 people as positive for the genetic mutation that causes ACD, protecting them from blindness,” said Scott Korney, chief operating officer of Avellino Lab USA. “By providing the AGDS Test to the ophthalmologist community here in the U.S., Avellino Lab USA is proud to help make eye correction surgery safer for the over 350,000 U.S. patients who undergo LASIK each year.”

The non-invasive AGDS test involves a simple mouth swab from the patient’s cheek. The sample is sent to Avellino Lab USA and within 24 to 48 hours, the results are provided to the ophthalmologist, with 100 percent accuracy. Based on a negative result, patients are able to proceed with the planned LASIK procedure with increased confidence.

The Avellino Lab USA facility has been inspected by the California Department of Public Health and received the Clinical Laboratory Improvement Amendments (CLIA) and CA State licensure for commercial diagnostic operations.

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