Asuragen gains New York's OK to launch autism and thyroid tests

Asuragen gained approval to start offering two of its key molecular diagnostics tests in New York state, milestones that will help boost the standards of care and give the Texas company another opportunity to grow its market reach.

New York granted a clinical laboratory permit for Asuragen's Xpansion Interpreter, a molecular diagnostic test that determines the likelihood that a woman will have a child with fragile X syndrome, a genetic cause of autism spectrum disorders and other intellectual disabilities. Asuragen's miRInform Thyroid test, which helps manage patients with thyroid nodules, also won a clinical laboratory permit from the state. This diagnostic looks for 17 different genetic changes and mutations in patients with thyroid nodules who may have thyroid cancer but lack a clear cytological determination based on initial fine-needle aspirate biopsies.

Both signoffs are a big deal, because now the tests are available in all 50 states, increasing access and boosting Asuragen's revenue potential for both products. Each test, as Asuragen sees it, is in a crucial area where there is a need for more precise and thorough diagnostic attention.

Fragile X syndrome is considered to be the most common inherited cause of autism and other intellectual disabilities, the company noted. Xpansion Interpreter is designed to dig deeper and more accurately screen for patients at risk of having kids with fragile X syndrome. In 2013, a study from the company validated that goal, showing that the test could help boost the standard of care by reducing unnecessary testing.

"We now know that many of the women found to be carriers do not have a high risk for having a child with fragile X," Sally Nolin, the lead author and director of the Fragile X Laboratory at the New York Institute for Basic Research in Developmental Disabilities, said at the time of the study's release in March 2013. "This test allows us to identify those women at greatest risk and to avoid unnecessary prenatal testing in those that are not." 

Fragile X syndrome happens when production of a protein needed for normal brain development becomes altered by a mutation in the FMR1 gene. The CGG section of the genetic code repeats on a fragile area of the X chromosome, and Xpansion Interpreter can predict the likelihood of the CGG repeats, which can lead to fragile X in a child if they total a certain amount.

Asuragen is also smartly targeting the thyroid cancer space. The company cites American Cancer Society statistics pointing to it as the fastest growing cancer in the U.S., and its test can spot DNA mutations and better screen patients with indeterminate thyroid nodules as a result.

In today's market, diagnostics companies can have the most inventive tests out there, but that matters little unless they can gain access to their targeted patients, through state and federal regulatory and licensing approvals, and insurer agreements to help cover the diagnostic test costs. Asuragen's success with New York officials matters greatly in that context.

The company itself has had a long history. It has existed in its current incarnation since 2006. That's when Ambion, a molecular biology reagent company launched in 1989, sold the research products division to Applied Biosystems Group-- now Life Technologies ($LIFE)--and formed Asuragen with 100 initial employees from Ambion's diagnostics and molecular biology service divisions, according to the company's website.

Asuragen spun off Mirna Therapeutics in 2009.

- read the release

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