Becton Dickinson CPO Detect Test

Now Diagnostics launched its over-the-counter First To Know finger-stick pregnancy test in Italy, making it the first OTC, blood-based pregnancy test for sale in the EU. The test is available in pharmacies in Italy through an exclusive distribution agreement with Welcome Pharma. Now Diagnostics CEO Gianni Furino said the company plans to expand the availability of First To Know throughout the EU in the coming months. The test is not US Food and Drug Administration-cleared for OTC sale or for home use in the US. 

Agilent Technologies announced the release of a new accessory kit that enables the company’s fully automated Dako Omnis tumor sample staining system to analyze tissue samples using three different techniques simultaneously. With the new kit, the system can process immunohistochemical, fluorescence in situ hybridization, and chromogenic in situ hybridization assays. All tests for a specific case can be run simultaneously, and a clinician can get results in a "greatly reduced timeframe, enabling better patient case management," Agilent said.

Curetis has announced the US commercial launch of its molecular diagnostic Unyvero System and the Unyvero LRT Application Cartridge, a test cartridge to detect lower respiratory tract infections. The cartridge, which was cleared together with the system by the US Food and Drug Administration earlier this year, covers more than 90 percent of infection cases of hospitalized pneumonia patients, detecting pathogens and genetic resistance markers directly from aspirate samples in less than five hours.  

Novacyt's protein diagnostics division, Lab21, has launched a new product for the diagnosis of infectious mononucleosis (IM), or glandular fever. The product, PathFlow Mononucleosis, is a qualitative lateral flow immunoassay for the detection of IM antibodies in the blood. IM is frequently misdiagnosed as streptococcal pharyngitis, a bacterial infection, due to common clinical presentation of the diseases at onset. However, Epstein–Barr, a virus, causes infectious mononucleosis, so it doesn't respond to antibiotic treatment. PathFlow Mononucleosis provides a rapid and effective differential diagnosis to patients with IM over streptococcal pharyngitis, Novacyt said.

Abbott has launched the Afinion 2 analyzer, a new generation of its Afinion system, in the US. The Afinion 2 provides patients with health information that they can discuss with their providers during a single visit, Abbott said. It is a compact rapid, multi-assay platform that streamlines and simplifies the delivery of results at the point of care for measurements of hemoglobin A1c (HbA1c) and albumin-to-creatinine ratio (ACR), the firm said. Healthcare professionals receive results in three minutes for HbA1c and five minutes for ACR, and can thus dedicate more time to counseling patients within a single office visit, Abbott said. The new analyzer is already available with HbA1c, ACR, C-reactive protein, and a lipid panel in select markets outside the US.

Precipio has launched two new research-use only ICEme kits for the detection of mutations in KRAS Exons 2 and 3 in pancreatic cancer. The kits use the company's proprietary ICE-COLD PCR liquid biopsy technology and are available for both qPCR and Sanger sequencing platforms. According to Precipio, its non-invasive, low-cost enrichment technology is well-suited for laboratories developing screening and monitoring tests. The kits will be priced at approximately $100 per specimen.

InvivoScribe Technologies has released its LymphoTrack Dx TRB Assay for the Illumina MiSeq platform, a CE-marked next-generation sequencing kit for in vitro diagnostic use. The assay completes the menu of Invivoscribe's CE-marked clonality assays on the MiSeq, enabling small and large laboratories to identify and track clonal rearrangements.