CE mark

NGeneBio Raises $11M

The company has also achieved a CE-IVD mark for its HemeAccuTest, which targets hematological malignancies.

The company and Women & Infants Hospital of Rhode Island are currently evaluating the technology to determine the performance of the test.

The assay can identify KRAS, NRAS, PIK3CA, BRAF, and EGFR gene mutations, as well as 19 gene rearrangements of the ALK, ROS1, RET, NTRK1, and MET genes from FFPE.

With CE-IVD marking, the melt curve analysis-based screening assay is available for sale in the EU and other areas that recognize the designation.

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 test is designed to detect cancer-driver gene variants associated with certain targeted solid tumor therapies, and is validated as a companion diagnostic.

The PCR assay is intended to help detect TB-causing bacteria and determine if it harbors mutations associated with isoniazid and rifampicin resistance.

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 firm's molecular assay directly detects varicella-zoster virus DNA from a patient's cerebrospinal fluid and provides results in about one hour.

Pages

Thermo Fisher Scientific says it will no longer sell machines in China's Xinjiang region, according to the Wall Street Journal.

New Scientist reports that 20 percent of human and yeast proteins are uncharacterized.

The University of Zurich's Ruedi Aebersold and his colleagues analyzed a dozen HeLa cell lines to find differences in gene expression, protein levels, and more.

In Nature this week: protein-coding variants associated with body-fat distribution, and more.