Asuragen Receives New York State License for Molecular Genetic and Oncology Clinical Laboratory Testing
Approval received for Xpansion Interpreter® and miRInform® Thyroid Tests
AUSTIN, Texas--(BUSINESS WIRE)--Asuragen, Inc., a molecular diagnostic company using genomics to drive better patient management, announced today that it had received a clinical laboratory permit from the state of New York to offer Xpansion Interpreter, its reflex test for fragile X carriers and miRInform Thyroid for use in the management of patients with thyroid nodules. With this approval, Asuragen can now offer its CAP-certified CLIA laboratory Xpansion Interpreter and miRInform Thyroid Tests in all 50 states.
“This milestone highlights our commitment to the development of unique testing solutions that assist patients to make more informed decisions about their risk associated with fragile X syndrome.”
Fragile X syndrome is the most common inherited cause of intellectual disability and autism. The likelihood of having a child with fragile X syndrome is linked to the number of CGG repeats and the number of AGG interruptions in the Fragile X Mental Retardation (FMR1) gene. Xpansion Interpreter is the first clinically available laboratory-developed FMR1 test that determines the total number of CGG repeats and number of AGG interruptions. Xpansion Interpreter can aid in personalizing the risk for at-risk patients of having a child with fragile X syndrome.
Features of fragile X syndrome vary widely but can include mild to severe cognitive delays, seizures, behavioral differences such as perseverative speech and hand flapping, and characteristic facial features such as large ears and a long face. About 1 in 4,000 males and 1 in 8,000 females has fragile X syndrome. The molecular basis for fragile X syndrome is an increased number of trinucleotide CGG repeats in the 5' promoter region of the FMR1 gene. FMR1 alleles can be further categorized based on the number of CGG repeats, and premutation alleles may expand from parent to child to a full mutation that can cause features of fragile X syndrome. In addition, people with premutations may develop fragile X-associated Tremor/Ataxia Syndrome and women may develop fragile X-associated Primary Ovarian Insufficiency.
“We are delighted to be able to offer these tests to physicians and their patients in New York State,” said Darin Leigh, SVP of Commercial Operations at Asuragen. “This milestone highlights our commitment to the development of unique testing solutions that assist patients to make more informed decisions about their risk associated with fragile X syndrome.”
Thyroid cancer is the fastest growing cancer in the United States with the American Cancer Society (ACS) reporting a 59% increase in the incidence of this disease between 2006 and 2011. This year, according to the ACS, approximately 63,000 patients will be diagnosed with thyroid cancer, with women accounting for 48,000 of these. The rising incidence increases the demand for biopsies at the rate of approximately 16% per year and currently over 525,000 fine needle aspirate (FNA) biopsies are performed annually in the US.
The miRInform Thyroid Test interrogates 17 different genetic changes, including 14 DNA hotspot mutations in BRAF and K-, H-, and N-RAS genes, along with 3 RNA translocations (RET-PTC1, RET-PTC3 and PAX8/PPARγ). All these aberrations are recognized by the American Thyroid Association (ATA) and National Comprehensive Cancer Network (NCCN) guidelines as useful in helping with management of patients with cytologically indeterminate thyroid nodules from FNA biopsies. There are more than 50 peer reviewed publications describing clinical utility of these markers in improving the performance of FNA cytology.
Asuragen is a molecular diagnostics company using genomics to drive better patient management in oncology and genetic diseases through best-in-class clinical testing solutions. The company uses a breadth of technologies and scientific talent to discover, develop and commercialize diagnostic products and clinical testing services with efficiency and flexibility both internally and for our companion diagnostic partners. Today, Asuragen’s products, services and technologies drive countless patient management decisions across oncology, genetic disease and other molecular testing modalities. In the future, we envision the company’s development of molecular-based clinical diagnostics will help transform medicine by improving clinical outcomes and health economics. For more information, visit www.asuragen.com.