The Dx Pipeline: A Roundup of the Month’s Key New Product Launches

A team led by Johns Hopkins Kimmel Cancer Center announced that it has developed a new test capable of determining whether patients with pancreatic cysts do or do not need surgery or further surveillance. The CompCyst test uses imaging and molecular data to classify pancreatic cysts into three groups: 

  • Cysts with no potential to become cancerous;
  • Cysts with a small risk of becoming cancerous; and
  • Cysts with a high risk of becoming cancerous. 

The team is looking to do a 1,000-patient clinical study of the test in the hopes of securing FDA approval to bring it to the commercial market.

Here’s a summary of the key launches that did take place from mid-June to the third week of July, 2019:

Company(ies) Product(s)/Service(s)
Abbott Afinion HbA1c Dx assay for use on both the Afinion 2 Analyzer and Afinion AS100 Analyzer
Roche Ventanna ROS1 (SP384) Rabbit Monoclonal Primary Antibody, which company claims is first in vitro diagnostic immunohistochemistry (IHC) tests for detecting ROS1 protein in cancers
HTG Molecular Diagnostics Updated version of HTG EdgeSeq Reveal data analytics software
Co-Diagnostics Vector Smart NAM test to identify presence of West Nile virus, St. Louis encephalitis and western equine encephalitis in mosquito populations
Circulomics Two new versions of its Short Read Eliminator kit for the depletion of short DNA fragments from high molecular weight DNA samples
Biotechne Multiplex in situ hybridization RNAscope HiPlex Assay for tissues
ZeptoMetrix NATtrol Respiratory Verification Panel, a 20-member respiratory panel for molecular testing for infectious disease
Cellecta Dual-sgRNA libraries designed for CRISPR activation (CRISPRa) and CRISPR interference/repression (CRISPRi) genetic screens
23andMe New genetic health risk report for MUTYH-Associated Polyposis (MAP)
BillionToOne Unity prenatal screening assay
AutoGen Xtract 16+ system to extract DNA or RNA from molecular diagnostic, biological, clinical and forensic sample types
Thermo Fisher Scientific Four versions of Invitrogen Collibri DNA Library Prep kits for use with high-throughput Illumina sequencing systems
Porvair Sciences ChIP kit range dedicated to Drosophila
Expedeon Lightning-Link Metal Labeling Kits for immunoassay-based applications to support single cell analysis
GenScript Upgrade to its GenBrick Gene Synthesis platform
Phitonex New line of NovaFluor dyes
Phase Genomics New ProxiMeta platform, which includes 8-pack ProxiMeta kit with cloud-based ProxiMeta Analysis
Fluidigm Three Imaging Mass Cytometry Maxpar panel kits are for immune-oncology research
Fluidigm New CyTOF software for use with the Hyperion Imaging System for cellular biomarker identification
Fluidigm Seven new cadmium metal labeling kits for mass cytometry
Cytek Biosciences New version of its Cytek Aurora flow cytometry system
BGI 676 Quality Genome for high de novo genome assembly using MGI’s DNBSEQ and stLFR technologies
Biocept Target Selector NGS Breast Panel to detect and monitor genomic biomarkers associated with breast cancer run on Thermo Fisher Scientific’s Ion Torrent NGS platform
Qiagen Microbial Insights AR (QMI-AR) integrated genomic database
GeneCast Research-use-only kits for BRAF, EGFR and JAK2 mutation detection

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