The three-year trial used immunoassays and PCR testing, and found 335 Babesia microti positive samples among 89,153 blood donations.
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 case is being framed as either upholding a strong patent regime or dealing a blow to US-based manufacturing as part of the global supply chain.
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.
The company has rededicated itself to a fully blood-based test pipeline, with its next assays focused on women's health, including endometriosis and ovarian, uterine, and cervical cancers.
In Nature this week: genome-wide transcriptome analysis of brain samples from people with autism spectrum disorder, flounder genome, and more.
Researchers used T-cell transfer therapy to target mutation KRAS, according to the New York Times.
The US Senate has passed the 21st Century Cures Act, which would provide a funding boost at NIH while overhauling FDA policies.
Bloomberg reports that President-elect Donald Trump is considering Jim O'Neill for Food and Drug Administration commissioner.