New Products

Jun 28, 2017

Redbud Labs MXR

Redbud Labs released MXR, a microfluidic chip that accelerates molecular assay by as much as tenfold. Redbud said the chip is specifically designed for diagnostic consumables and can be added to almost any cartridge design. MXR is a microfluidic mixer that delivers rapid, gentle agitation that can improve reaction kinetics, decrease variability, and simplify cartridge design. 

Jun 28, 2017

Roche Harmony NIPT 22q11.2 deletion

Roche has added 22q11.2 deletion testing to the Harmony Prenatal Test's menu, allowing laboratories and physicians using the test to screen for 22q11.2 deletion syndrome, which is associated with heart defects, poor immune system function, cleft palate, and delayed development. The 22q11.2 deletion is estimated to occur in 1 out of every 2,000 to 4,000 live births. 

Jun 26, 2017

Premaitha Health Updated Iona Test

Premaitha Health has updated its Iona noninvasive prenatal test, which now includes the first trimester combined test risk score as an option in its software. The company said that it completed a validation study to show that the Iona test in combination with the first trimester combined screen was as accurate as estimating prior risk using maternal age.

Jun 26, 2017

BloodCenter of Wisconsin's Diagnostic Laboratories hematology test panels

BloodCenter of Wisconsin's Diagnostic Laboratories launched seven hematology genetics test panels. The new panels include nonmalignant hematology disorders, such as platelet function disorders, inherited thrombocytopenia, and congenital neutropenias.  

Jun 22, 2017

Grifols TDMonitor assays

Grifols has launched a therapeutic drug monitoring testing service as part of its Texas-based clinical diagnostics laboratory menu. Its TDMonitor assays measure levels of infliximab, Humira (adalimumab), and Entyvio (vedolizumab) and the antidrug antibodies, and support therapeutic decisions by clinicians.

Jun 22, 2017

Quest Diagnostics Blueprint For Athletes

Quest Diagnostics has expanded the capabilities of its biomarker testing service called Blueprint for Athletes to include at-home specimen collection using the Mitra microsampling device, which uses a few drops of blood. The at-home collection sampling is available now for Blueprint for Athletes Hormone package and is expected to become available with other Blueprint for Athletes services later this year.

A Blueprint for Athletes "concierge collection" service also is available now, in which trained phlebotomists will go to a person's home to collect a blood specimen for testing. Blueprint for Athletes is based on medical-grade diagnostic tests and is subject to federal and state regulations. It is available in 33 states. 

Jun 16, 2017

Premaitha Sage Prenatal Screening Solution

Premaitha Health has launched Sage, a noninvasive prenatal testing solution. The test uses the latest technology to detect placental DNA in maternal blood sample, and uses the company's cloud-based bioinformatics analysis to allow laboratories to upload sequencing data files to the cloud for remote analysis. The panel includes full chromosome analysis. The testing will be available through Yourgene Bioscience Singapore, which was acquired by Premaitha in March.

Jun 15, 2017

TATAA Biocenter GrandPeformance Assays

TATAA Biocenter has launched GrandPerformance assays for expression profiling single circulating tumor cells. The assays' workflow is based on preamplification allowing precise measurements of 96 specific expression markers per cell. They are also optimized for single-cell sensitivity.

Jun 07, 2017

Prevention Genetics Tests for Female, Male Infertility

Prevention Genetics has launched genetic tests for both female and male infertility. The new infertility sequencing panels cover 83 genes for females and 80 genes for males. They also include chromosomal microarray, Y chromosome deletion testing, and FMR1 CGG repeat expansion for premature ovarian failure. Tests must be ordered through a qualified health provider and will be performed in the company's CLIA- and ISO 15189:2013-accredited laboratory.

Jun 05, 2017

Global Lyme Diagnostics GLD Test

Global Lyme Diagnostics has made its Lyme disease test, the GLD Test, available. The blood-based test is based on research by Richard Marconi, a professor of microbiology and immunology at the School of Medicine at Virginia Commonwealth University. The GLD Test uses chimeriope technology for the construction of diagnostic antigens to detect Lyme disease strains. 

Jun 02, 2017

Phosphorus Hereditary Cancer Panels

Phosphorus has released new advanced tests for hereditary cancers. The tests are organized into three panels — a common/high-risk panel comprising 32 genes that interrogates "the most actionable and widely-recognized genes across cancer types"; a 114-gene pan cancer panel; and disease-specific panels covering 11 specialties, including breast; colorectal; brain/nervous system; leukemia; pancreatic; ovarian/uterine; renal; thyroid; melanoma; prostate; and pediatric cancer. 

Jun 02, 2017

Centogene Noninvasive Prenatal Testing

Centogene has launched its CenoNIPT test for noninvasive prenatal testing. The test uses Illumina VeriSeq NIPT Solution. It is performed on a single maternal blood sample and combines the latest next-generation sequencing technology with the highest quality medical reporting. The company's optimized workflows allows patients to receive a full medical report within five working days.

May 30, 2017

Sophia Genetics Whole Exome Solution, Clinical Exome Solution

Sophia Genetics launched the Whole Exome Solution and Clinical Exome Solution for the detection of disease-related genetic variants. The two solutions use AI technology to give clinicians a better understanding of genomic data for more accurate and personalized clinical care, the firm said. 

May 26, 2017

Horizon BRAF-Resistant Melanoma PDX Models

Horizon Discovery has launched four new BRAF-resistant melanoma patient derived xenograft (PDX) models. The company has partnered with the Wistar Institute of Anatomy and Biology in Philadelphia to make their melanoma PDX models available to the research community. The models are created by implanting cancerous tissued from a human primary tumor directly into immunodeficient mouse or rat models.They can support drug efficacy studies, the company said.

May 24, 2017

Interpace TERT biomarker

Interpace Diagnostics launched the TERT biomarker for ordering along with its ThyGenX molecular thyroid cancer test. The TERT marker is a molecular predictor of the aggressiveness of thyroid cancer, and the addition of it to the ThyGenX test will provide evidence that a positive result indicates the cancer is likely to be more aggressive in nature, the company said. Physicians can order the new marker as part of the ThyGenx mutation panel or on an individual basis. 

May 23, 2017

Sera Prognostics Birth Risk Blood Test

LabCorp today announced the nationwide availability of the PreTRM blood test, developed by Sera Prognostics, which provides an "early and individualized" prediction of preterm birth risk for pregnant women. The companies had previously announced a strategic collaboration through which LabCorp became the exclusive US distributor of Sera’s PreTRM test. LabCorp was also a lead investor in Sera’s recently closed Series C financing round.

May 23, 2017

Biocartis IVD NRAS Test for Colorectal Cancer

Biocartis has launched its Idylla NRAS Mutation Test. The CE-marked IVD assay joins the company's existing Idylla NRAS-BRAF Mutation Test, allowing for more flexibility in geographies where BRAF testing for metastatic colorectal cancer patients is not reimbursed. According to Biocartis, the NRAS-only assay detects 18 mutations directly from a single slice of FFPE tumor tissue in approximately two hours, with less than two minutes hands-on time.
May 17, 2017

Quanterix Simoa Neurology 4-Plex A Assay

Quanterix launched the Simoa Neurology 4-Plex A assay, which the firm said is the first test that can simultaneously measure four protein biomarkers from either CFS or directly from blood samples, for studying traumatic brain injury and other neurodegenerative disorders. The four biomarkers on the panel include neurofilament light, tau, glial fibrillary acidic protein, and ubiquitin carboxyl-terminal hydrolase L1.

May 17, 2017

NMDX HER-2/neu blood test kits

NMDX, a company spun off from now-defunct Nuclea Technologies, is now selling HER-2/neu blood testing kits, acquired from Nuclea. The test measures the presence of HER-2 protein for patients with metastatic breast cancer. 

May 17, 2017

Claritas Genomics HLH/MAS Region of Interest Test

Claritas Genomics has launched the Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) Region of Interest test to its menu of exome-based molecular diagnostic testing. The test encompases 20 genes relevant to autosomal recessive or x-linked primary HLH and auto-inflammatory disease that can trigger MAS. It also identifies variants in exons and adjacent intronic sequences and detects deep intronic variants in UNC13D. The assay uses the company's dual-capture, dual sequencing platform method.

May 16, 2017

Cynvenio Biosystems ClearID Lung Cancer Test

Cynvenio Biosystems has launched its ClearID Lung Cancer blood test. The 11-gene panel leverages next-generation sequencing technology to identify tumor-related genetic mutations that can be treated with targeted therapies. It identifies ctDNA burden and detects somatic mutations as low as .13 percent with an accuracy of 99.76 percent and a sensitivity of 95.9 percent, the firm said.

May 16, 2017

NHGRI Genomics Resource

The National Human Genome Research Institute and several professional medical societies have partnered to make a genomic resource available online for use in the classroom and for "self-directed learning of genetics and genomics concepts for use in the clinic." The resources are available on the Genetics/Genomics Competency Center website. 

May 11, 2017

Intermountain's ICG100 ONCO Focus Panel

Intermountain Precision Genomics, a cancer sequencing service provided by Intermountain Healthcare, is now offering the ICG100 ONCO Focus Panel. The next-generation sequencing panel analyzes five genes, KRAS, BRAF, NRAS, EGFR, and KIT, and is a leaner offering than the ICG100 Comprehensive Cancer panel which gauges 162 genes. Intermountain said that the five-gene panel requires as little as 20 nanograms of DNA, or between 5,000 and 8,000 cells, and has a two-day turnaround time, as opposed to the two weeks it takes to get back results from the comprehensive panel. The ICG100 ONCO Focus Panel evaluates genes that are frequently mutated in melanoma, lung, and colon cancers.

May 11, 2017

ASI HiPath

Applied Spectral Imaging introduced the HiPath system for the imaging and analysis of PD-L1 assays. it determines PD-L1 protein expression by calculating a percentage of viable tumor cells show partial or complete membrane staining while providing automatically the rumor proportion score. HiPath provides digital automation of IHC tissue analysis, and allows pathologists to capture images, receive computer-aided scoring, and generate automatic reports with comple case statistics, ASI said. 

May 10, 2017

GenomeDx Decipher Bladder Cancer Classifier

GenomeDx Biosciences launched its Decipher Bladder Cancer Classifier, a clinical assay for subtyping muscle invasive bladder cancer. The commercial launch follows the publication of a study supporting the assay's development and validation. The test is for use by physicians to stratify patients into more accurate risk groups than can be done with traditional diagnostic diagnostic tools. It also is for identifying those patients who are most likely to benefit from additional treatment. 

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