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| Ariosa's Harmony prenatal test--Courtesy of Ariosa Diagnostics |
Roche's ($RHHBY) Ariosa Diagnostics nabbed a CE mark for software for its noninvasive prenatal test, a win for the company months after it scored expanded coverage for the tool in the U.S.
The San Jose, CA-based company got European regulators' signoff for the Forte software used in its Harmony Prenatal test, which uses cell-free DNA from pregnant women's blood to screen for fetal genetic abnormalities including Down syndrome, Edwards syndrome and Patau syndrome. Ariosa will keep the software on a server at labs to process patient data in the country of testing, the company said in a statement, potentially broadening the tool's global reach.
"Forte software is a cornerstone of the Harmony Prenatal Test, which has been one of the most trusted brands in noninvasive prenatal testing among patients and OB/GYNs to determine the risk of trisomies in more than 500,000 patients in the world," Dave Mullarkey, Ariosa's chief operating officer, said in a statement. "Achieving this regulatory milestone validates our efforts and allows Ariosa to partner with labs throughout Europe and license the Forte software required for technology transfers."
But Ariosa is not stopping there. The company also plans to grant licenses for its noninvasive prenatal testing technology to labs in Europe so they can develop their own tests in-house, a "significant step" in the company's goal of bolstering worldwide access to the tool, Ariosa CEO Ken Song said in a statement.
The CE marking and licensing deals come on the heels of more good tidings for Ariosa, as it continues to charge ahead with plans for growth after selling out to diagnostic heavyweight Roche in December. Last year, Ariosa grabbed expanded national coverage for its Harmony prenatal test, offering the tool to 125 million additional patients across private insurance plans such as Signa, Anthem and Premera. The company also snagged Medicaid coverage for its test in additional states including New York.
But it hasn't all been smooth sailing for Roche/Ariosa. The company is fighting tooth and nail for its share of the prenatal diagnostics market, which is forecast to grow to $3.6 billion by 2019. Last month, archrival Illumina ($ILMN) slapped Ariosa with a patent infringement suit over technology used in the company's Harmony prenatal test. Ariosa struck back, claiming its test uses proprietary techniques, rather than random sequencing, to screen cell-free DNA of chromosomes. But Illumina is defending its intellectual property, saying Ariosa's test infringes on technology used in its competing product.
- read the statement
- here's more about licensing deals