Invitae Breast Cancer STAT Panel Expansion

Dec 08, 2016

Invitae has launched an expansion of its Breast Cancer STAT panel. The expansion contains two additional breast cancer predisposition genes — ATM and CHEK2 — and a faster turnaround time with results available in as few as five days at no additional cost. The panel also includes seven well-established genes associated with a significantly increased risk of developing breast cancer: BRCA1, BRCA2, CDH1, PALB2, PTEN, STK11, and TP53. Testing is available for both blood and saliva samples.

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Mar 19, 2018

MDNA Life Sciences Mitomic Prostate Test

MDNA Life Sciences has launched the Mitomic Prostate Test Real-Time PCR Kit for research use only in Europe. The liquid biopsy test is designed for the early detection of prostate cancer in advance of biopsy, is independent of PSA and age, and is available for licensee laboratories to conduct in-house validation studies and controlled testing. The assay targets the 3.4-kb mitochondrial DNA deletion and is designed for use on real-time PCR platforms. Each kit contains all necessary reagents to process up to 21 patient samples, MDNA Life Sciences said. The company noted that a CE-IVD version of the kit will be available in July.

Mar 16, 2018

Fimmic Aiforia Cloud

Fimmic has launched Aiforia Cloud. Formerly called WebMicroscope, Aiforia Cloud has new Create tools that allow users to generate their own deep learning algorithms by training convolutional neural networks to learn, detect, and quantify specific features of interest in tissue images. The technology brings together a deep learning AI image analysis cloud solution with self-service and automatized pahtology image analysis capabilities, Fimmic said. 

Mar 15, 2018

Coriell Life Sciences Bacterial Vaginosis Assay

Coriell Life Sciences launched a solution for the quantitative diagnosis and reporting of bacterial vaginosis. Coriell, together with Quantigen, developed the assay and a reporting algorithm that runs on Thermo Fisher Scientific's real-time PCR-based OpenArray technology. The solution provides affordable and comprehensive sample analysis with rapid turnaround times, allowing Coriell to report which microorganisms are present and at what quantities. The test aids in the differential diagnosis of other vaginal infections that clinically present with the same signs and symptoms as bacterial vaginosis, Coriell said.

Mar 14, 2018

Bio-Techne MimEX GI

Bio-Techne released MimEX GI for generating 3-D gastrointestinal tissue on a 2-D surface. The platform uses characteristics of adult ground-state stem cell to generate 3-D gastrointestinal epithelial tissue on a 2-D surface. The system comprises specialized media and reagents that allow for the expansion and differentiation of ground-state adult stem cell populations from the gastrointestinal tract, while maintaining their regional specificity, Bio-Techne said. 

Mar 14, 2018

Sebia FLC Kappa, Sebia FLC Lambda

Sebia launched two serum-free light chain assays for multiple myeloma testing. The tests called sebia FLC Kappa and sebia FLC Lambda use an ELISA format and were developed to provide more consistent results by overcoming the challenges in analytical performance and coherence often seen in currently available testing methods, the firm said. The assays are CE marked, and Sebia intends to apply for 510(k) clearance for them later this year. 

Mar 14, 2018

Optrascan Third Generation On-Demand Digital Pathology System

Optrascan launched its third generation On-Demand Digital Pathology system for researchers and clinicians. The firm said that its third generation Optrascan brightfield scanner is now able to acquire a whole slide image from a formalin-fixed paraffin-embedded sample on a glass slide in under 60 seconds and at the cost of a traditional digital microscope. The next generation system is available at a price of $20,000. With faster scan times, it will provide technicians and physicians access to images quickly and help keep their workflow moving at a steady pace, Optrascan said.

Mar 13, 2018

Sekisui/Mesa Biotech Silaris Influenza A&B Test

Sekisui Diagnostics has launched the Silaris Influenza A&B test, a 30-minute PCR-based point-of-care assay developed by Mesa Biotech. The test and testing platform were recently cleared by the US Food and Drug Administration and CLIA-waived under the Mesa branding, the Accula Flu A/Flu B. The test system includes a palm-sized dock and disposable test cassettes. Last year Sekisui Diagnostics inked an exclusive contract with Mesa to distribute the system in the US and Canada.

Mar 09, 2018

PierianDx Clinical Genomics Services

PierianDx this week launched clinical genomics services to complement its Clinical Genomics WorkSpace software product. One component of the services involves preparing labs for precision medicine and expanded molecular testing, which includes planning with the clinical team, molecular tumor board development, physician engagement, and integrating technology into LIMS and EMRs. The other component of the services is focused on the clinical lab such as assay validation, selection, and interpretation. The company said that it also offers turnkey and custom assays performed in a CLIA-certified, CAP-accredited laboratory.

Mar 07, 2018

Leica Biosystems Bond-III IHC and ISH Stainer

Leica Biosystems has launched a new version of the Bond-III IHC and ISH stainer for use by clinical laboratories in the US. The instrument includes Active Visual Management to simplify bulk reagent management. It allows staff to monitor instrument readiness from across the lab while performing other tasks. It also includes Bond Controller software version 6.0 to improve lab management. It facilitates the reduction of slide data entry times, so runs can begin sooner and cases can be available for diagnosis earlier. 

Mar 02, 2018

SQI Diagnostics, Predictive Health Diagnostics PULS Cardiac Test

SQI Diagnostics and Predictive Health Diagnostics have announced the validation, commercial transition, and installation of SQI's sqidlite system to run Predictive Health's PULS Cardiac Test. The PULS multi-biomarker assay integrates quantification of the body's immune system response to endothelial damage to identify subclinical residual cardiac risk and predict a five year risk of heart attack. The sqidlite system and test kits will be available to Predictive Health's global customer base for purchase to run the PULS Cardiac test in their own laboratories. 

Feb 28, 2018

Metabolon Meta UDx

Metabolon launched the Meta UDx to help clinicians in the diagnosis of rare diseases, as well ailments in pediatric and adult patients that are difficult to diagnose. The test is analytically validated under CLIA as a laboratory-developed test and requires a small plasma sample. It looks for biomarkers or biochemical pathway changes that may indicate metabolic effects associated with diseases or disorders. Meta UDX surveys about 1,000 metabolites, Metabolon said. 

Feb 26, 2018

Genomic Health Oncotype DX AR-V7 Nucleus Detect

Genomic Health has launched the Oncotype DX AR-V7 Nucleus Detect Test, a liquid biopsy assay intended to predict treatment response in men with advanced prostate cancer. Developed and performed by circulating tumor cell firm Epic Sciences, the new assay is the first of its kind to be commercially marketed. The test detects the presence of a splice variant of the androgen receptor protein in the nucleus of CTCs using Epic's detection and analysis platform.

The presence of AR-V7 has been shown in research studies to be predictive of whether men will respond to androgen receptor-signaling inhibitors like enzalutamide and abiraterone, or might be better served by chemotherapy.

Feb 20, 2018

Beckman Coulter Diagnostics, NTE-Sener DxM 6100 Autoplak Advanced System

Beckman Coulter Diagnostics and NTE-Sener have partnered to launch the DxM 6100 Autoplak Advanced automated plate streaking system in Europe. The platform automates and integrates the core aspects of microbiology specimen testing, Beckman Coulter said, and streamlines routine tasks. As a result, laboratories can manage increasing testing volumes by allowing them to reallocate technical resources as needed. Beckman Coulter and NTE-Sener, which is part of the Sener group, originally signed a deal in June to make Beckman Coulter the sole distributor of the DxM 6100 Autoplak Advanced System in most European countries.

Feb 13, 2018

SeraCare Seraseq Breast CNV; Lung and Brain CNV Mix

SeraCare Life Sciences launched the Seraseq Breast CNV and Seraseq Lung and Brain CNV Mix, reference materials for analyzing copy number variation. Both have been built with biosynthetic technology that can be easily scalable to incorporate new CNVs over time, and were developed so that clinical labs conducting NGS-based tumor profiling for cancer can better understand and characterize their assays, SeraCare said. They were precisely quantified using highly sensitive digital PCR assays to analyze amplification of EGFR, MET, FGFR3, MYC, ERBB2, and MYCN genes at +3, +6, and +12 copies against a single well-characterized genomic background, the company said.

Feb 09, 2018

Sema4 Natalis

Sema4 has launched Natalis, a supplemental newborn screening test designed to detect 193 childhood-onset diseases or disorders. In the US, newborns are typically screened for 34 health conditions on the recommended uniform screening panel, but the conditions vary by state and represent only a fraction of the genetic diseases that can manifest in a child's first decade, Sema4 noted. As a supplemental test, Natalis screens for more than five times the number of genetic diseases than a state's standard hospital test, the company said. Every Sema4 Natalis order also includes a pharmacogenetic analysis of how a baby is likely to respond to 38 medications commonly prescribed at an early age. The test uses DNA sequencing analysis, and sample collection can be performed at home with a cheek swab, the company said.

Sponsored by
Thermo Fisher Scientific

In this webinar, the first in the “New Frontiers in Liquid Biopsy Research” series, Bea Bellosillo, head of pathology at the Hospital del Mar, will discuss her experience evaluating an early-access lung cancer panel that detects copy number variants and fusions.


Proximity ligation technology generates multi-dimensional next-generation sequencing data that is proving to solve unmet needs in genomic research. 

Sponsored by
Thermo Fisher Scientific

In this webinar, the second in the “New Frontiers in Liquid Biopsy Research” series, Luca Quagliata, Senior Consultant in the Molecular Pathology Unit at University Hospital Basel, will share two specific unmet needs within his lab’s liquid biopsy research that led to the eventual evaluation, adoption, and implementation of the latest liquid biopsy Oncomine NGS solutions from Thermo Fisher.


This webinar will provide an in-depth case study demonstrating how reference standards can be used to develop and validate circulating tumor DNA (ctDNA)-based assays.