Abbott said that the next-generation molecular POC assays have also been CLIA waived for use on the Abbott ID NOW instrument, formerly called Alere i.
The test is intended to identify patients with ROS1, NTRK, and ALK gene fusions for treatment with TP's investigational drug repotrectinib.
Palmetto GBA's decision that large syndromic MDx panels may not always be necessary prompted GenePOC's decision to further target smaller panels.
The test, which runs on the firm's Revogene molecular diagnostics instrument, has now been launched in Canada.
The a single-tube, multiplex real-time PCR-based MeltPro High Risk HPV test identifies 14 high-risk genotypes of human papillomavirus and was previously CE marked.
Asuragen's technology will be used in the Early Check study to identify children with rare health conditions, such as fragile X syndrome, before symptoms appear.
The companies will use Natera's Signatera circulating tumor DNA assay to assess response to NEO-PV-01, a clinical trial-stage neoantigen cancer vaccine.
The firm said that the assay uses vaginal or rectal swabs to identify Group B Streptococcus DNA in about an hour. It has filed for 510(k) clearance with the US FDA.
The test is designed to detect the presence or absence of the Zika virus in serum or plasma collected alongside urine from patients with suspected infection.
The firm said it will use the net proceeds for R&D, including the continued development of its Acuitas AMR gene panels and Acuitas Lighthouse software.
The company's third quarter revenue increase was driven in part by strong growth in its molecular biology clinical applications.
The revenue growth was fueled by continued volume increases in Precipio's pathology services unit, which benefited from a recently expanded sales team.
The PCR assay is intended to help detect TB-causing bacteria and determine if it harbors mutations associated with isoniazid and rifampicin resistance.
Investigators developed a droplet digital PCR assay targeting driver mutations and found that changes in circulating DNA were correlated with response to radiation.
The court ruled that Roche's claims are patent-ineligible because they are "directed to a natural phenomenon and lack any inventive concept" for a patent.
ARMADA began as a consortium of eight US organizations but has increased to 50 institutions in 20 countries and signed on actor Bill Pullman as a spokesman.
The companion diagnostic for Pfizer's Xalkori identifies 14 ROS1 gene fusions by analyzing tumor messenger RNA from human tumor tissue or body fluids.
The three-year extension increases the minimum purchase commitments for the Unyvero system, resulting in an increase in potential revenues of €30 million to Curetis.
The kit is designed to quantify HIV-1 RNA in blood samples and runs on Bioneer's PCR-based ExiStation automated molecular diagnostics system.
The so-called enVision HPV test performed well in a comparison to Roche's Cobas HPV assay, and the Singapore researchers are considering other test applications.
The United Nations is to consider a ban on field testing gene drives at a meeting being held next week, Technology Review reports.
The Associated Press reports that gene-edited food may soon be for sale.
The US Department of Health and Human Services is beginning a series of meetings on human fetal tissue research, Stat News reports.
In Cell this week: epigenetic change linked to glioblastomas, rare and low-frequency variants contributing to multiple sclerosis risk, and more.