The FDA also cleared a 23andMe genetic health risk report for a syndrome associated with a higher risk of developing hereditary colorectal cancer.
The assay is designed to detect ribosomal RNA from four clinically relevant Babesia species and runs on the company's Procleix Panther system.
The firm published a study showing the technology could be used to determine antimicrobial susceptibility as well as minimum inhibitory concentrations.
The University of Toronto is developing a platform that enables swapping of various sensing technologies that could measure different analytes in a range of applications.
The firm used about $38.8 million on Feb. 1 to repay all outstanding principal, interest, related fees, and other obligations under an existing loan agreement.
The kit, which was launched today, leverages real-time RT-PCR technology to detect and quantify hepatitis C virus-specific RNA with genotypes 1 to 6.
The BioFire FilmArray Pneumonia panel will be used to optimize clinical trial enrollment for an antibiotic to treat combat carbapenem-resistant A. baumannii infections.
The firm said it expects to achieve full-year revenue of $100 million in 2023, based on its commercial and development opportunities and operational investments.
The RT-qPCR-based assay, which has 510(k) clearance, is designed to rapidly differentiate sepsis from systemic inflammatory response syndrome.
The device can process high-volume sputum samples for PCR-based Mycobacterium tuberculosis detection at smear-negative, culture-positive levels.
Qiagen's Q4 revenues of $403.2 million fell short of the consensus analyst estimate though its adjusted EPS of $.40 was in line with Wall Street expectations.
The submission by Curetis' distribution partner Beijing Clear Biotech used data previously collected for regulatory approvals in the US and Europe.
The researchers also determined that the two most widely used IGRAs used for diagnosing the disease in developed countries are not accurate for active TB.
Roche Diagnostics had sales of CHF 12.88 billion in 2018. For the fourth quarter, diagnostics sales totaled CHF 3.5 billion, up 10 percent year over year.
Researchers at Washington University in Saint Louis will use new funds to confirm preliminary findings on malaria-infected kids in a second location in Africa.
Within diagnostics, the firm posted molecular diagnostics revenues of $164.3 million, up 11 percent from $148.6 million in fiscal Q1 2018.
The firm expects to use the funding to meet demand for its Steripath platform, which improves accuracy, consistency, and predictability of diagnostic lab tests.
The new regulatory approvals add to previous approvals in Singapore, expanding the firm's reach in the Association of Southeast Asian Nations region.
A molecular assay used in combination with patient-collected samples had similar accuracy to testing with clinician collected samples.
The funds will help commercialize Ador's NATlab reader, a point-of-care MDX platform for sample-to-answer identification of specific infectious diseases.