Molecular Diagnostic to Make Laser Eye Surgery Safer
Avellino Lab (Menlo Park, Calif.) recently launched Avellino DNA Dual Test for LASIK Safety, a genetic test that can detect for both types of granular corneal dystrophy (GCD1 and GCD2). Patients with these corneal opacity conditions experience serious post-surgery vision complications. Such genetic testing is performed in the vast majority of patients prior to corrective […]
Avellino Lab (Menlo Park, Calif.) recently launched Avellino DNA Dual Test for LASIK Safety, a genetic test that can detect for both types of granular corneal dystrophy (GCD1 and GCD2). Patients with these corneal opacity conditions experience serious post-surgery vision complications. Such genetic testing is performed in the vast majority of patients prior to corrective laser surgery in parts of Asia, and the company hopes to make the test part of routine practice in the United States too. GCD1/2 usually develops slowly, but if a patient with the condition undergoes vision correction (LASIK, LASEK, PRT, phototherapeutic keratectomy, and corneal transplant), they are at extreme risk of experiencing eventual blindness. While physicians can diagnose the condition with visual examination and family history in some cases, physical symptoms of the condition may not be present until later in life, putting unsuspecting patients at risk if they undergo the surgery. There is no cure for GCD, but the Avellino DNA Dual Test can detect the presence of the genetic mutation, allowing the patient to take precautionary steps to postpone the progression of the condition, including forgoing vision correction surgery and using ultraviolet protective lenses. The test involves a cheek swab sample that is sent to Avellino Lab USA’s CLIA-certified laboratory. Results are returned to the ordering physician within 24 to 48 hours. Avellino Lab has found the prevalence of GCD to be one out of every 1,078 refractive surgery candidates (based on 430,000 patients tested). This type of genetic test is the standard of care in Asia, where the company says that 80 percent to 90 percent of vision correction surgery candidates in Korea and Japan are tested. However, the company acknowledges the practice is not yet widespread in other parts of the world. “Although it is not yet standard-of-care in North America, the U.S./Canadian market now ranks third behind Korea and Japan for genetic testing of laser vision correction candidates,” Weston Nichols, Avellino Lab USA’s sales and marketing director, tells DTET. “This growth trend likely means that genetic testing will become standard-of-care [included in guidelines] during the next few years.” The test is not currently reimbursed by Medicare or private payers but is “affordable,” the company says. Nichols says the test represents a small fraction of the total cost of laser vision correction surgery, so many clinics are choosing to incorporate the test into the total cost of the surgery. Takeaway: The Avellino DNA Dual Test for LASIK Safety is yet another indicator of how genetic testing is permeating routine practice in a wide variety of medical specialties, now including ophthalmology. Avellino Lab’s experience with clinics incorporating the test’s costs into the total cost of surgery illustrates a trend toward bundled costs of patient care.