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 […]
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.
NEWLY LAUNCHED PRODUCTS & SERVICES
| 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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