Starting in late 2020, public health insurance is expected to pay for NIPT if a trisomy is suspected and this constitutes an "unacceptable burden" for the pregnant woman.
LifeCodexx's PrenaTest will be available to women in Malaysia, Singapore, Thailand, Brunei, Vietnam, the United Arab Emirates, and elsewhere in the Middle East.
The company plans to launch the new qNIPT test, which uses methylation-specific quantitative PCR to detect fetal epigenetic biomarkers, in the near future.
The company's PrenaTest BioIT analysis software is now also cleared for use with a new methylation-specific qPCR assay for the detection of fetal trisomy 21.
Last week, the G-BA, a committee that decides about reimbursable medical services in Germany, said it will start a methods evaluation of noninvasive prenatal testing.
