- PR Newswire•yesterdayHarmony® Prenatal Test for assessment of Down syndrome and other chromosomal disorders receives CE mark
OTCQX:RHHBY) today announced that the Harmony Prenatal Test for assessing the probability of Down syndrome (Trisomy 21) and other chromosomal disorders has received the CE mark. This enables laboratories to perform local in vitro diagnostic (IVD) testing in countries that accept the mandatory conformity marking. Local testing availability permits laboratories to comply with reimbursement requirements and expedite test results for healthcare providers and expectant parents in their regions. "This is exceptionally good news as CE marking of the Harmony Prenatal Test will make highly accurate cfDNA testing accessible to a wider spectrum of pregnant women," said Professor Kypros Nicolaides, M.D., director of the Fetal Medicine Foundation and the Harris Birthright Research Centre for Fetal Medicine at King's College Hospital in London.
- PR Newswire•yesterdayFDA Grants Roche Label Extension for the cobas® EGFR Mutation Test v2 for use with Plasma as a Companion Diagnostic for TAGRISSO™
PLEASANTON, Calif., Sept. 29, 2016 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX, RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a label extension of the cobas ® EGFR ...
Roche Holding AG (RHHBY)
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