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Ariosa Dx Conducts Over 40K Tests and Expands into 50 Countries in Q3 2013

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Ariosa Diagnostics said today that it tested over 40,000 pregnant women with its sequencing-based noninvasive Harmony Prenatal test for fetal aneuploidies in the third quarter of 2013 and over 150,000 women since its commercial launch last year.

The San Jose, Calif.-based privately-held company launched its test in May 2012 through a collaboration with Laboratory Corporation of America and has since expanded into 50 countries across six continents.

"The strong demand for our test is driven by the clear value proposition it provides over conventional prenatal screening tests," CEO Ken Song said in a statement. "In each country that we have launched, we have seen brisk uptake. We are pleased with the initial adoption of our test and look forward to broadening access."

The company also expects to have results from a multi-center study comparing the Harmony test to conventional screening in the first half of 2014. The trial, called the NEXT study for non-invasive examination of trisomy, has enrolled over 18,900 subjects. Additionally, Genome Canada is funding a trial of the Harmony test.

The 40,000 tests conducted in the third quarter put Ariosa slightly ahead of Sequenom, which said in a conference call discussing its third quarter results that it had accessioned 36,600 of its MaterniT21 Plus tests (see story, this issue).

Ariosa also recently came out ahead in a lawsuit when the US District Court for the Northern District of California granted it summary judgment and invalidated a key Sequenom patent, US Patent No. 6,258,540, saying it covers a phenomenon of nature, which is unpatentable.

Ariosa's Harmony test uses a different method than Sequenom's MaterniT21 Plus test, targeting the chromosomes of interest as opposed to taking a whole-genome shotgun sequencing approach.

As such, the test has a significantly lower list price, $795 compared to Sequenom, which charges patients with insurance a copay of $235 and bills the insurance companies $2,900, but charges $1,700 to uninsured patients. Illumina-owned Verinata Health offers its noninvasive prenatal test for $1,500, and Natera's test has a list price of $2,750.

Because Ariosa is a private company, it did not disclose its third quarter revenues or any other details about its financial performance, but at the JP Morgan conference earlier this year, Song said that the company would become profitable by the end of the year and that it had raised $67.5 million since its inception and did not have any debt.

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