Avellino Lab USA Launches New DNA Test for LASIK Safety

First genetic test designed to make LASIK safer for the 350,000 U.S. patients who undergo the procedure each year

Apr 24, 2014, 08:02 ET from Avellino Lab USA

MENLO PARK, Calif., April 24, 2014 /PRNewswire/ -- Avellino Lab USA, developer of the Avellino-GENE Detection System (AGDS™) Test, the first genetic test for Avellino Corneal Dystrophy (ACD), will introduce the Avellino DNA Dual Test for LASIK Safety,  a genetic test that can detect for both ACD and another genetic mutation, Granular Corneal Dystrophy type I (GCD1), at the American Society of Cataract and Refractive Surgery Annual Symposium (ASCRS) in Boston, Massachusetts at booth #266.

GCD1 is characterized by small translucent dots, or granules, resembling crushed bread crumbs that form in the various layers of the cornea. Similar to ACD (also known as GCD2), GCD1 typically develops slowly. However, should a patient with GCD1 undergo vision correction surgery (e.g. LASIK, LASEK, PRK), they are at extreme risk of experiencing eventual blindness. With the Avellino DNA Dual Test, a patient can now simultaneously determine if he or she has GCD1 or GCD2 prior to undergoing LASIK, avoiding the risk of post-surgery vision complications.

Granular Corneal Dystrophy (type 1 and 2) has been diagnosed in patients throughout the world and is one of the more well-known corneal dystrophies related to genetic mutations. Unfortunately, many physicians assume incorrectly that they can diagnose the condition through a visual examination and family history. However, many patients do not show physical symptoms of the condition until later in life. Consequently, relying solely on traditional methods for diagnosis can put patients at risk. While there is no cure for GCD, the Avellino DNA Dual Test is able to detect the presence of the genetic mutation, allowing the patient to take precautionary steps to postpone the progression of the condition, including avoiding vision correction surgery.

"We have been utilizing the Avellino DNA Test for LASIK Safety since its availability in the United States, and it has been a fantastic tool for both our physicians and patients in increasing their confidence prior to LASIK," said Dr. Tom Tooma, founder of NVISION Laser Eye Center. "Now, with the Avellino DNA Dual Test, patients can go into treatment knowing they are even more protected from adverse outcomes such as loss of vision."  

The Avellino DNA Dual Test is easy and safe. The test involves a simple mouth swab to determine whether a person carries the GCD1 or the GCD2 gene mutation. Specifically, the ophthalmologist takes 10 swipes from the inside of each cheek in order to obtain an adequate sample. The sample is then sent to Avellino Lab USA, a Clinical Laboratory Improvement Amendments (CLIA) certified molecular diagnostic testing lab. Within 24 to 48 hours, the results are provided to the physician to share with the patient.

"At Avellino Lab USA, we pride ourselves in providing the ophthalmology community with the most advanced tools to help them safeguard their patients," said Scott Korney, COO of Avellino Lab USA. "The Avellino DNA Dual Test is yet another testament to our commitment to make LASIK safer for every patient. We are thrilled to now be able to offer the test to ophthalmologists across the United States."

In March 2013, Avellino Lab USA launched the Avellino-GENE Detection System (AGDS) Test, the world's first genetic test to detect ACD (also known as GCD2). The Avellino DNA Test for LASIK Safety positively identifies, with high accuracy, if a person has the genetic mutation, preventing the post-op onset of GCD1 or GCD2. In fact, the Avellino DNA Test for LASIK Safety has become the standard of care in Korea (160 LASIK clinics using this test) and Japan (>80% of LASIK patients tested).

About Avellino Lab USA
Avellino Lab USA has developed the first and only commercially available testing system, the Avellino DNA Dual Test for LASIK Safety, for Granular Corneal Dystrophy type 1 (GCD1) and Granular Corneal Dystrophy type 2 (GCD2), also known as Avellino Corneal Dystrophy (ACD). The company's proprietary genetic diagnostics system provides fast, safe and affordable evaluations of an individual's genetic predisposition to GCD1 and/or GCD2.  With the Avellino DNA Dual Test, Avellino Lab USA is able to positively identify, with high accuracy, a patient's GCD status. Based on the test's results, patients and their physician can make an informed decision when considering vision correction surgery.

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Jessica Wolter

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SOURCE Avellino Lab USA