Definiens Immunoprofiling Panel

Natera has launched Signatera, a research-use-only circulating tumor DNA assay. Signatera consists of analyzing whole-exome sequencing data from a patient's tumor sample to design a targeted, custom-designed assay to analyze 16 or more mutations that were identified in the tumor sample. According to Natera, the assay can detect variant allele frequencies down to 0.01 percent and is optimized to achieve high specificity by requiring detection of multiple mutations for a ctDNA-positive call, leading to fewer false positives.

SeraCare Life Sciences has launched a set of reference materials for vlaidaing and monitoring Zika virus test methods. The AccuSet Zika Performance Panel is a 10-member panel consisting of patient samples demonstrating a range of reactivity for Zika IGM antibodies, and assessed for cross-reactivity to dengue and chikungunya. The panel is intended for use by researchers, diagnostic manufacturers, and clinical laboratories to develop, evaluate, and validate Zika serological test methods. The panel members have been comprehensively tested following the recommended US Centers for Disease Control and Prevention algorithm and using several commercially available methods.

SeraCare also launched the AccuSpan Zika RNA Linearity Panel and the AccuPlex Zika RNA Reference Material, both formulated using the company's AccuPlex recombinant virus technology. These safe, non-replicative, non-infectious, and fully extractable positive reference materials support the development and evaluation of molecular diagnostics detecting Zika virus.

Exosome Diagnostics launched the MedOncAlyzer 170, a liquid biopsy pan-cancer panel that interrogates exosomal RNA and circulating tumor DNA in one assay. MedOncalyzer 170 is a targeted panel for tumor profiling that identifies clinically actionable and functionally important mutations across multiple cancer types, using as little as 0.5 ml of patient blood or plasma. 

Canon BioMedical has launched the Novallele HRM Analyzer, web-based software capable of analyzing data from different thermocyclers and well plate formats. The software provides an intuitive and easy-to-use graphical interface with comprehensive algorithms capable of analyzing high-resolution melting (HRM) data from different thermocyclers, Canon said. The software also complements Canon's Novallele genotyping assays, in conjunction with the Novallele Controls Sets, to analyze HRM data.

DNAStack has released an update to its genomics software platform. The cloud-based system features a new application called Workflows to assist researchers and clinicians in building, running, and sharinge bioinformatics workflows across sites. The software remains free for research; DNAStack charges per use for computation and data storage.

Bioline, a subsidiary of Meridian Bioscience, has launched the JetSeq Clean Kit, a clean-up system for next-generation sequencing workflows. The kit uses paramagnetic bead technology to purify nucleic acid fragments during NGS library prep. It removes salts, primers, primer-dimers, and dNTPs while selectively binding library fragments to magnetic particles based on their size.

Asuragen has launched a new CE-marked QuantideX qPCR BCR-ABL minor kit for identifying minor (e1a2) BCR-ABL fusion transcripts in patients with chronic myeloid leukemia. The new test joins the firm's existing FDA-cleared and CE-marked QuantideX qPCR BCR-ABL IS Kit that covers major (e13a2, e14a2) fusions.

The two kits can be combined in a streamlined and common workflow, and Asuragen said it is also expanding the capabilities of its QuantideX Reporter, analysis software, which accompanies the CE-marked QuantideX qPCR BCR-ABL IS Kit, to allow laboratories the ability to report CML patient disease burden on the International Scale after reviewing ABL1 copy number, in compliance with European LeukemiaNet guidelines.