NEW PRODUCTS

The Dx Pipeline
A roundup of the month’s key new product launches

As usual, genome and sequencing products dominated the diagnostics pipeline last month. Exceptions included rapid diagnostic testing products from Alere, oncology lung testing kits from IncellDx, tuberculosis assays from Cepheid and early-stage breast cancer prognostic and recurrence tests from Myriad Genetics. Here’s a rundown of notable new products and services launched last month:

NEW PRODUCTS & SERVICES
Company(ies) Product(s)
Invitae 80 new and 24 updated panels for diagnosis and diagnostic confirmation of inherited immunologic and metabolic disorders
Invitae Patient Insights Network™, permission-based network for patients to share health experiences, contribute de-identified clinical data and track research, treatment and education
Invitae Launch of exome sequencing and interpretation services
Invitae Genetic Health Screen tests, expansion of ongoing proactive genetic testing pilot program
Invitae New test for diagnosis of spinal muscular atrophy
Alere Alere™ Malaria Ag P.f, technology for high-sensitivity, rapid diagnostic testing of malaria
Biogazelle mRNA sequencing service for human plasma and other bodily fluids
Roche MagNA Pure 24 System for nucleic acid extraction and purification
Myriad Genetics Early-stage breast cancer prognostic test assessing risk of post-surgery recurrence and whether patients can safely skip chemotherapy
Thermo Fisher Scientific Applied Biosystems QuantStudio 5 Real-Time PCR system for human identification
Helomics D-Chip, searchable bioinformatics platform for multi-omic and clinical data on cancer patients
Cepheid, Rutgers New Jersey Medical School, and FIND Xpert MTB/RIF Ultra test for diagnosing tuberculosis and resistance to the antibiotic rifampicin
Agilent Technologies SureSelect Clinical Research Exome V2, new target enrichment technology for NGS
Diatech Pharmacogenetics Kits for PCR-based oncology testing and detecting circulating free DNA
Prenetics ONEdna, a DNA screening test service
NuGen Technologies Universal Plus mRNA-seq and Trio RNA-seq., a pair of RNA sequencing kits
LifeLabs Genetic counseling service for patients undergoing BRCA1/2 testing in Canada
PathoFinder and UgenTec Cloud-based CE-IVD interpretation solution for PathoFinder’s next generation multiplex PCR 2SMART assays
Paragon Genomics CleanPlex target enrichment solution
Bionano Genomics Bionano Access 1.0 and Bionano Solve 3.0 software for genomic analysis
Strand Life Sciences StrandNGS 3.0, updated version of  company’s NGS data analysis and visualization platform
Swift Biosciences Accel Amplicon CFTR panel for detecting variants and mutants in all exonic and select intronic regions of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene
Swift Biosciences Accel-NGS XL Library Prep kit for PacBio’s Single Molecule, Real Time SMRT sequencing
FlowJo SeqGeq, platform-agnostic desktop application for analyzing single-cell omics data
Genetic Signatures EasyScreen STI Kit for simultaneous detection of 12 most common sexually transmitted infections
IncellDx OncoTect iO Lung kit, flow cytometry based assay
Bruker Avance Neo NMR Research Platform, updated version of earlier platform
Genomenon Mastermind Panel Design Service for researching disease-gene-variant relationships
Cellecta Driver-Map Human Genome-Wide Gene Expression Profiling kit
GeneNews BreastSentry, risk stratification test for breast cancer
Empirical Bioscience Agarose Gel Extraction kit
Personal Genome Diagnostics PlasmaSELECT 64, targeted panel using bioinformatics for pan-cancer tumor profiling
NanoString nCounter mRNA amplification kit
NanoString Universal cell capture kit
NanoString Two new nCounter assays
SGI-DNA Next-Generation Sequencing Library Construction Kits for its BioXP 3200 system
Bioline (wholly-owned subsidiary of Meridian Bioscience) JetSeq Library Quantification Kit
10X Genomics High-throughput solution for profiling paired V(D)J transcripts from hundreds to millions of lymphocytes
SeraCare Life Sciences Multiplexed Seraseq Inherited Cancer DNA Mix reference material for inherited disease testing by NGS
Optra Health iPhronesis Knowledge Automation for Clinical Genomics platform
Synthego New chemically modified synthetic single guide RNAs for CRISPR genome editing
Variantyx Genomic Intelligence platform for automating NGS testing process from sample collection thru clinical report generation
FDNA Face2Gene Research, application using facial analysis, deep learning and artificial intelligence for clinical genomic discoveries
EntroGen Colorectal Cancer panel
EntroGen Thyroid Cancer Mutation Analysis kit
EntroGen Thyroid Cancer Fusion Gene Detection kit
Phosphorus Genetic tests of inherited conditions associated with early onset cardiovascular disease
Omic Analytics Proteolabels, new proteomics-focused plugin for Progenesis QI mass spectrometry analysis software
Agena Bioscience UltraSeek Lung and Colon panels for detection of somatic mutations from lung and colon cancers
Beckman Coulter Diagnostics DxC 700 AU chemistry analyzer for mid- to high-volume clinical labs
Asuragen AmplideX PCR/CE TOMM40 Kit using PCR and capillary electrophoresis to detect poly-T polymorphisms in TOMM40 gene
PreventionGenetics PGxome Custom Panels, whole-exome NGS panels for clinical genetic testing
Vela Genomics (subsidiary of Vela Diagnostics) TheraKey™, cloud solution for NGS  clinical interpretation and reporting
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