The Dx Pipeline
A roundup of the month’s key new product launches
From - Laboratory Industry Report As usual, genome and sequencing products dominated the diagnostics pipeline last month. Exceptions included rapid diagnostic testing products from… . . . read more
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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