Where once there were few competitors selling non-invasive prenatal diagnostics, now there are many. Ariosa Diagnostics is one of the new rivals in the space that roared onto the market through 2013, and it is acutely aware of the need to expand the number of patients it reaches. After an aggressive rollout this year, the San Jose, CA, company is touting two new clinical studies showing how successful its Harmony test is in assessing the risk of Down syndrome in twin pregnancies.
In one study, Ariosa said Harmony successfully helped analyze the fetal fraction for just one of the twins, pointing to the test's ability to target genetic abnormalities with one fetus. That can be a challenge, the company said, because two fetuses are sometimes genetically identical and sometimes not.
A second blind study assessing 192 twin pregnancies correctly classified 9 out of 10 pregnancies with fetal trisomy 21, 1 pregnancy with fetal trisomy 13 and no false positives. Trisomy 21 is linked to Down syndrome. Harmony has tested in general as having a 99% accuracy rate, versus an error rate of up to 20% for other tests.
Both studies are published in the journal Fetal Diagnosis and Therapy.
Thomas Musci, Ariosa's chief medical officer, said in a statement that the company is committed to the value of published, peer-reviewed studies that show Harmony's value as a trisomy risk assessment test. He added that the latest data showed value using the test in patients pregnant with twins.
Ariosa has aggressively expanded this year and scored some major victories. In October, the company defeated rival Sequenom ($SQNM) in a prenatal testing patent battle. The company also hit the lucrative Brazilian market with Harmony. Ariosa, along with Natera and Illumina's ($ILMN) Verinata Health, also scored major deals to provide diagnostic testing to California women through the state's prenatal screening program.
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