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

Abusy month in product launches included a new CE-marked IVD version of Invivoscribe Technologies’ LeukoStrat CDx FLT3 Mutation Assay, which the company describes as the first companion diagnostic for acute myeloid leukemia. The assay also secured FDA approval earlier this year.

Helix had a busy month. In addition to partnering with Illumina Accelerator to provide support services to consumer genetics startups (See Diagnostic Deals on page X for the details), the personal genomics firm launched a new online marketplace offering customers DNA sequence interpretations for ancestry, fitness, nutrition and other applications. The new service leverages mobile apps developed by partner companies Admera, Azumio, DNAFit, DotOne, EverlyWell, Exploragen, Genome Medical, Insitome, Intelliseq, Lose It!, National Geographic, Sema4, Titanovo and Vinome.

Here’s a rundown of the other key diagnostic product launches from late July through mid-August.


Company(ies) Product(s)
Invivoscribe Technologies New version of its LeukoStrat CDx FLT3 Mutation Assay, the first companion diagnostic for acute myeloid leukemia
Cynvenio Biosystems Second-generation PD-L1 expression test
Color Genetic test for familial hypercholesterolemia
Lexogen Small RNA-seq library prep kit compatible with Illumina sequencing instruments
Canon BioMedical Novallele HRM Analyzer, web-based software for analyzing data from different thermocyclers and well plate formats
DNAStack Workflows, a new app for its genomics software platform
Advanced Data Systems Augmented version of MedicsPremier PM for Laboratories to handle added, built-in capabilities for lab practice management
Meridian Bioscience (via its Bioline sub) JetSeq Clean Kit, a clean-up system for NGS workflows
Asuragen QuantideX qPCR BCR-ABL minor kit for identifying minor BCR-ABL fusion transcripts in chronic myeloid leukemia patients
Genohm Version 6.0 of SLIMS, a combination lab information system and electronic lab notebook platform
ArcherDx Archer VariantPlex Core Myeloid NGS panel that analyzes 37 genes related to myeloid malignancies
Synthego Modified synthetic single guide RNA libraries for arrayed whole human genome CRISPR screening
Roche Avenio Millisect System, a tissue dissection instrument
CloudLIMS New version of its pay-as-you-go LIMS, CloudLIMS Lite software
Thermo Fisher Scientific Applied Biosystems Precision ID GlobalFiler NGS STR Panel v2 and Converge Software 2.0 for forensic research
Thermo Fisher Scientific Applied Biosystems Axiom Asia Precision Medicine Research Array containing over 750,000 biomarkers for common and rare diseases
LabCorp ADAMTS13 test for thrombotic microangiopathy (TMA), a rare life-threatening blood-clotting disorder
Agilent Technologies AriaDx Real-Time PCR System
Agilent Technologies Agilent SureSelectXT HS, an updated version of its NGS library prep product
Fluidigm Advanta Immuno-Oncology Gene Expression Assay, a research-use-only qPCR assay
Empirical Bioscience 2X qPCR Probe Master Mix for probe-based quantitative PCR applications
Exosome Diagnostics MedOncAlyzer 170, liquid biopsy pan-cancer panel integrating exosomal RNA and circulating tumor DNA into single assay
SeraCare Life Sciences Reference materials for validating and monitoring Zika virus test methods
SeraCare Life Sciences ctDNA reference materials for development and validation of liquid biopsy assays

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