New Products

Apr 16, 2018

True Health PlanTrue

True Health has launched the PlanTrue genetic carrier screening test. The next-generation sequencing test analyzes up to more than 80 genes associated with early-onset genetic conditions that are both prevalent and actionable. It comes in five versions that cover between three and 82 genetic conditions.

Apr 11, 2018

MNG Laboratories MNGenome

MNG Laboratories has launched a clinical genome product, MNGenome. The test includes whole-genome sequencing to 30x coverage, as well a mitochondrial sequencing and repeat expansion detection. The test has a turnaround time of two to six weeks with a rapid option available for less than two weeks. The Atlanta, Georgia-based clinical laboratory offers the test for trios or proband-only.

Apr 10, 2018

CareDx HeartCare

CareDx has launched HeartCare, a comprehensive rejection surveillance solution for heart transplant recipients. HeartCare includes both AlloMap and AlloSure-Heart results for a holistic view into the health of a heart transplant patient, the company said. The diagnostic gives clinicians indications of patients' immune system activity and graft health

Apr 10, 2018

Beckman Coulter Diagnostics Access Sensitive Estradiol

Beckman Coulter Diagnostics has launched its Access Sensitive Estradiol for detecting estradiol levels in women, children, and men. The assay will help labs deliver accurate results for patients seeking answers to reproductive health questions, the company said. Its broad measuring range surpasses clinical decision limits for in vitro fertilization hyper-responders, and the launch follows the recent FDA clearance of Beckman Coulter's automated Anti-Müllerian Hormone assay. 

Mar 30, 2018

Foundation Medicine FoundationOne CDx

Foundation Medicine's FoundationOne CDx is now available in the US, following approval by the US Food and Drug Administration last year and finalization of a national coverage determination by the Centers for Medicare and Medicaid Services earlier this month. The test is available for patients with advanced solid tumor cancers. It assesses genomic alterations in 324 cancer genes and serves as a companion diagnostic for patients with certain types of non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer, and breast cancer to determine if they could benefit from one of 17 on-labeled therapies, of which 12 are approved as first-line therapy for their respective indication. In addition, the test reports genomic biomarkers, such as microsatellite instability and tumor mutational burden that can help inform the use of immunotherapies.

Mar 30, 2018

Immunodiagnostic Systems Sex Hormone, Sarcoidosis Assays

Immunodiagnostic Systems Holdings launched two assays in the European market for use with its automated system. Its IDS SHBG assay measures the levels of sex hormone binding protein in blood samples. Its IDS ACE assay is an angiotensin-converting enzyme blood test used to monitor the therapeutic treatment of diagnosed sarcoidosis.

Mar 28, 2018

Owlstone Medical Breath Biopsy Kits

Owlstone Medical has launched its Breath Biopsy Kits. The kits are based on the firm's Breath Biopsy platform, which detects volatile organic compound markers in breath. The kits will allow academic, clinical, and pharmaceutical research to quickly discover and validate breath-based biomarkers for detection and precision medicine research, it said. Earlier this month, the company said that it raised $15 million for the commercialization of its breath-based diagnostic technology. Owlstone aims to bring tests for lung cancer, colorectal cancer, and asthma to market on its Breath Biopsy platform in coming years.

Mar 28, 2018

CellMax Life PD-L1 Test

CellMax Life has added analysis of PD-L1 in circulating tumor cells to its test menu. PD-L1 status is used to determine if a patient might benefit from treatment with cancer immunotherapy drugs. 

Mar 26, 2018

Roche Ventana DP 200

Roche has launched the Ventana DP 200 high-speed slide scanner for digital pathology. The instrument has a scan speed of less than 49 seconds for a 15-by-15 millimeter scan area and is compatible with Digital Imaging and Communications in Medicine standards. It integrates with image management servers, including Ventana Virtusis software, and is CE marked for IVD use in countries that recognize the designation. In the US it is for research use only. 

Mar 22, 2018

Color Hereditary Heart Health Test

Color launched its Hereditary Heart Health Test this week. Priced at $249, the test gauges mutations in 30 genes associated with serious hereditary heart conditions that, if detected, can be monitored more closely and treated. The American College of Medical Genetics and Genomics supports testing for these genes. Color said that if patients have mutations in these genes, they can work with their doctors to create a plan to monitor and prevent potentially serious heart events.

Mar 20, 2018

Proteomics International Promarker D

Proteomics International Laboratories' partner Omics Global Solutions launched PromarkerD, a predictive diagnostic test for diabetic kidney disease. The test was launched through OMG's distributor in the Dominican Republic, Macrotech Farmaceutica. Proteomics International is in discussions with potential partners to bring the test to the US, Mexico, Japan, Australia, China, and Europe. The test is a mass spec-based laboratory-developed test, Proteomics International said, adding it anticipates another licensing deal for the test with a certified lab in coming weeks. The firm plans on developing an in vitro diagnostic immunoassay version of Promarker D for use in clinical labs. 

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-kilobase 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 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.

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