Ariosa Diagnostics, a subsidiary of Roche, specializes in non-invasive prenatal testing (NIPT) through its Harmony test, which utilizes cell-free DNA (cfDNA) derived from the pregnancy. This innovative approach allows for the evaluation of potential chromosomal conditions as early as 10 weeks into the pregnancy with just a single blood draw. The Harmony test is designed to screen for common chromosomal abnormalities, including Trisomy 21, 18, and 13, as well as sex chromosome aneuploidies and 22q11.2 microdeletions. The test is supported by extensive research, with 78 peer-reviewed studies validating its effectiveness as of December 2023.

The Harmony test not only provides critical information regarding the likelihood of chromosomal conditions but also offers the option to determine the sex of the baby. It is important to note that while the Harmony test serves as a valuable screening tool, its results should be interpreted in conjunction with other clinical findings and are not intended to be the sole basis for diagnosis. The test is CE-marked for use in Europe, although it has not received clearance or approval from the US FDA. Overall, Ariosa Diagnostics positions itself as a leader in prenatal screening, emphasizing both the accuracy of its testing and the importance of comprehensive prenatal care.

Ariosa Diagnostics(Roche)

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