New Products

Feb 19, 2019

LabCorp Certolizumab Concentration and Anti-Certolizumab Antibody DoseAssure CTZ Assay

Laboratory Corporation of America has launched its Certolizumab Concentration and Anti-Certolizumab Antibody DoseAssure CTZ assay. The test is part of the company's therapeutic drug monitoring DoseAssure portfolio and can be used by physicians to monitor individual drug response in patients who are on certolizumab, a monoclonal antibody to TNF-alpha used to treat certain inflammatory diseases. 

Feb 12, 2019

Myriad Genetics Prequel

Myriad Genetics commercially launched an enhanced version of the Prequel Prenatal Screen. The enhanced noninvasive prenatal screen analyzes 23 chromosome pairs instead of the standard five chromosomes (13, 18, 21, X and Y) it previously gauged. According to the company, the ability to assess additional chromosomes enhances the test's clinical utility by improving aneuploidy detection by 30 percent. Myriad is combining the NIPS Prequel tests with its Foresight Carrier Screen and is marketing them to all female patients, including women who have a high body mass index, are an ovum donor, or have a twin pregnancy. The expanded offering will be available for doctors to order on Feb. 19. 

Feb 12, 2019

Invitae NIPS

Invitae has added non-invasive prenatal screening (NIPS) to its offerings and integrated it as part of the firm's carrier screening test. The NIPS test analyzes cell-free DNA to assess whether a pregnancy is at heightened risk for three common chromosomal disorders, including trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome) and trisomy 13 (Patau syndrome). There is no additional charge for adding microdeletion and sex chromosome analysis. The carrier screen sequences 301 genes linked to serious genetic disorders, and now the same specimen collection kit will also enable NIPS. Invitae will begin accepting NIPS test orders next week.

Feb 07, 2019

ArcticZymes T4 DNA Ligase

ArcticZymes, a Biotec Pharmacon subsidiary, has released a T4 DNA ligase, its first commercial ligase enzyme. T4 DNA ligase is the most widely used enzyme in the ligase family, and works by joining DNA fragments together. It is used in the development of kits and products for in vitro diagnostics and molecular research. The ligase is produced under strict ISO 13485 guidelines, and can be used by customers either in combination with their own enzymes or alongside other ArcticZymes enzymes.

Feb 05, 2019

Baylor Genetics Clinical Whole-Genome Sequencing for Genetic Disorders

Baylor Genetics has launched clinical whole-genome sequencing for the diagnosis of rare genetic and inherited disorders. The test covers various mutation types throughout the genome, including single-nucleotide variants, indels, copy number variants, structural variants, regions of absence of heterozygosity, and repeat expansion variants. It requires a sample from patient and parents and has a turnaround time of 8 to 10 weeks.

Feb 05, 2019

OmegaQuant Analytics Prenatal DHA Test

OmegaQuant Analytics has launched its Prenatal DHA Test, which allows expecting mothers to monitor their omega-3 DHA level. According to the Sioux Falls, South Dakota-based firm, research suggests taking the nutrient DHA may reduce the risk of premature births. 

Feb 05, 2019

Caris Life Sciences MI Transcriptome

Caris Life Sciences has launched a whole-transcriptome assay, MI Transcriptome, to sequence the transcriptome of patients' tumors. The assay generates on average 60 million reads per patient to enable detection of fusions, splice variants, and gene expression. The company plans to submit the assay to the US Food and Drug Administration for pre-market approval review in the first half of the year.

Feb 04, 2019

Viracor Eurofins Baloxavir marboxil (Xofluza) Influenza A Antiviral Resistance PCR

Viracor Eurofins has launched its test for resistance to the antiviral Xofluza (baloxavir marboxil). The Baloxavir marboxil (Xofluza) Influenza A Antiviral Resistance PCR detects I38T/M/F mutations in H3N2 and 2009 H1N1 strains of influenza A and aids in evaluating resistance to the drug developed by Shionogi and Roche. Results can be available to healthcare providers within eight to 12 hours from the receipt of nasopharyngeal swab at Viracor's lab, the company said. 

Feb 04, 2019

Nichols Management Group LabScore

The Nichols Management Group has announced the launch of LabScore, a proprietary benchmarking service that provides laboratories with productivity and cost comparisons to institutions that are similar in size and acuity. LabScore uses published industry standards and internally developed productivity metrics based on lab complexity to benchmark lab services. LabScore can drill down into individual laboratory departments, including reference laboratory spend, to identify opportunities for improvement and provide metrics based on a lab's test mix and service menu. LabScore can be used by a variety of types of laboratories, including community hospitals and large academic medical centers with multiple locations. Esoteric testing comparisons are available in cytogenetics, human leukocyte antigen testing, and flow cytometry.

Jan 31, 2019

iQ Group Global Saliva Glucose Biosensor

The iQ Group Global has launched the Saliva Glucose Biosensor, a noninvasive, saliva-based glucose test for managing diabetes. According to the company, it is the first such test using saliva rather than blood for patient samples. The test comprises the Glucose Biosensor Unit and a digital healthcare app. The iQ Group Global added that it is working on a pilot research and development program with the University of Newcastle to expand beyond the saliva glucose diagnostic test and developing point-of-care diagnostic tests starting with tumor markers, hormones, and communicable diseases. 

Jan 31, 2019

Sysmex America's UN-2000

Sysmex America this week launched its UN-2000, a urine sediment analysis platform that combines flow cytometry and digital imaging to classify pathogenic cells, essentially eliminating the use of a microscope. According to the firm, the new platform's user-definable rule settings, intelligent data management with Urine Data Manager, and high-quality images produced by a digital camera, provide labs with more control over their process and analysis. The UN-2000 allows for flexible configurations that can increase throughput, as well as scalable options for upsizing and downsizing. The UN-2000 reduces the opportunity for clerical errors, lessens manual data entry, and decreases specimen-handling requirements, the firm added.

Jan 30, 2019

Bio-Rad Laboratories Liquichek Serum Indices

Bio-Rad Laboratories has launched the Liquichek Serum Indices for use as part of laboratory interference testing to monitor an instrument's ability to dtect hemolysis, icterus, and lipemia (HIL) specimen interferences in patients' samples. HIL interference can alter assay results and contribute to preanalytical variation affecting clinical chemistry testing. Liquichek Serum Indices is prepared from human-source material that resemble human samples at HIL-relevant concentrations. 

Jan 28, 2019

Biocept Target Selector Kits

Biocept has announced the availability of the first research-use-only (RUO) assay in a planned menu of kits for labs to run its Target Selector circulating tumor DNA assays in house.  The first assay being released is for high-sensitivity detection of EGFR mutations, which are among the most frequently evaluated biomarkers for lung cancer. Additional RUO test kits for other oncogene mutations are planned for launch in the future.

All will use Biocept's proprietary "switch blocker" technology, which the firm says produce industry-leading sensitivity for the detection of variants of interest. The EGFR kit and other assays can be used on a variety of analytical platforms including qPCR, Sanger sequencing, microarrays, mass-spectrometry, and next generation sequencing. 

Jan 28, 2019

SQI Diagnostics RA Test, Celiac Disease Monitoring Service

SQI Diagnostics announced its partner Microdrop has launched two at-home testing products for rheumatoid arthritis and celiac disease. The RA test measures biomarkers for the condition and provides information to patients for discussions with their docturs. Microdrop also launched a celiac disease monitoring service, which allows a patient to be continuously monitored to determine the effectiveness of their diet and treatment. The celiac monitoring service follows on the Imaware celiac screening test launched last month by Microdrop.

Jan 25, 2019

Roche Cobas Plasma Separation Card

Roche has launched the Cobas Plasma Separation Card for quantitative HIV viral load testing. The card, which received CE-marking earlier this month, is a sample collection device that takes a small amount of blood from a patient's fingertip. It simplifies blood collection and sample transportation, which is useful in areas of extreme heat and humidity. It also meets the World Health Organization's sensitivity standard of less than 1,000 cp/mL. The card is available in countries accepting the CE mark for use with the Cobas AmpliPrep/Cobas TaqMan HIV-1 and the Cobas 4800/6800/8800 HIV-1 tests.

Jan 24, 2019

Biocare Medical Valent

Biocare Medical has launched the Valent, an open, fully automated in vitro diagnostic staining platform. The system enables users to process 48 slides simultaneously, allowing for multiplexing immunohistochemistry capability. The open platform allows users to apply enzyme pretreatments, antibodies, detections, or chromogens from any source, Biocare said. 

Jan 23, 2019

Bio-Rad Laboratories qUAntify Advance Control

Bio-Rad Laboratories has launched the qUAntify Advance Control for urinalysis testing in clinical labs. The control is used to monitor the precision of laboratory urinalysis test procedures, and it contains human urine solution and offers 31 days of open vial stability for all analytes, including ketones at room temperature. Bio-Rad added that the Unity Interlaboratory Program and Unity QC Data Management Solutions are availabe for use with qUAntify Advance. 

Jan 22, 2019

Intermountain Healthcare Precision Genomics ICG100 Myeloid Malignancies Panel

Intermountain Healthcare Precision Genomics has announced its ICG100 Myeloid Malignancies Panel to help classify and diagnose multiple blood cancer types. The panel includes 63 genes and uses peripheral blood, bone marrow aspirate, extracted DNA, or fixed samples to detect faulty gene alterations through next-generation sequencing. According to the firm, the panel identifies variants in genes linked to several cancers, including acute myeloid leukemia, myeloid proliferative neoplasm, myeloid dysplastic syndrome, and myeloid dysplastic/myeloid proliferative overlap disorders. 

Jan 22, 2019

Thermo Fisher Scientific ImmunoCAP Specific IgE

Thermo Fisher Scientific has launched its ImmunoCAP Specific IgE blood test for Ara h6. The test is for use by medical providers to better determine which patients may be at risk for life-threatening sensitivity to the Ara h6 protein component in peanuts. The test has been cleared by the US Food and Drug Administration for in vitro diagnostic use. The ImmunoCAP line of tests include assays for cross-reactive carbohydrate determinants and profilins, allergens that are contained in various plants, pollens, and foods. 

Jan 17, 2019

XIFIN's VisualStrata

XIFIN this week launched VisualStrata, a precision medicine informatics platform that curates and visualizes diagnostic, clinical, and financial data documenting patients' journey through diagnosis and treatment to outcomes. The firm said the new platform provides healthcare professionals with deeper insights into optimal disease treatments and can help drive personalized care decisions. VisualStrata seamlessly integrates with most electronic medical record systems and electronic health record systems, as well as with other products that collect patient clinical, diagnostic, and financial data. 

It also supports organizational objectives such as clinical improvement initiatives, efficiency programs, physician engagement, and population health efforts, the health information technology firm said.

Jan 15, 2019

Roche uPath Digital Pathology Software

Roche has introduced uPath, an enterprise software system for digital pathology that replaces the previous Ventana Virtuoso software from Roche subsidiary Ventana Medical Systems. The new uPath system promises to decrease image rendering times and integrate automated image analysis functions, according to the company. In developing uPath, Roche acquired Leeds Virtual Microscope technology from the University of Leeds, U.K., and the Leeds Teaching Hospitals NHS Trust in the UK.

Jan 09, 2019

Sclero-Smart

Specialty biotech firm Gemelli Biotech has launched Sclero-Smart, a blood-based test that measures levels of anti-vinculin, an autoantibody which has been found to be elevated in sclerodema patients and associated with gastrointestinal complications. The finding of the association suggests a link between sclerodema and the gut microbiome, the Los Angeles-based firm said, and could lead to new microbiome-related diagnostic tools and therapeutics for the disease. The Sclero-Smart, which uses an ELISA format measures anti-vinculin levels in patients with systemic sclerosis and sclerodema. 

Jan 08, 2019

Yourgene Sage 32 Plex

Yourgene Health has launched the Sage 32 plex test, a high-throughput noninvasive prenatal testing and analysis solution for clinical laboratories. It runs on Thermo Fisher Scientific's Ion Torrent sequencing platform and allows 32 samples to be processed in parallel. The test, which will be available internationally, has improved performance due to workflow enhancements and upgraded analysis methods. Yourgene plans to launch a CE-IVD-marked version of the library preparation kit for the Sage 32 plex workflow in the coming months. The Sage test differs from Yourgene's other NIPT, the Iona test, in that it screens for a wider range of conditions, including trisomies 21, 18, and 13; sex chromosome aneuploidies; and clinically relevant microdeletions. The analysis uses a cloud-based bioinformatics solution called Sage Link.

Dec 21, 2018

Contextual Genomics 'Find It' and 'Follow It' Assays

Contextual Genomics, a Vancouver, Canada-based cancer genomics company, said that it has completed development of two new products: an improved version of its Find It hotspot panel for detection of genomic mutations in solid tumour cancers; and its Follow It hotspot panel for detection of the same genomic mutations in blood plasma.

The Find It panel now screens for 146 somatic genome alterations found in solid tumor cancers to identify optimal therapeutic treatments and recognize acquired drug resistance mutations. The assay is supported by Contextual's cloud-based genome analysis engine (CGIRP).

The Follow It panel screens for cell-free circulating tumour DNA in plasma, and is designed to  be used in patients with widespread metastatic disease at diagnosis and as a time series monitoring tool to read out tumor burden and treatment resistance. Follow It will screen for all of the same somatic genome alterations as Find It and can be used to follow disease progression for patients, including those whose tumors were initially tested with Find It.

Dec 21, 2018

DiaSorin Molecular Primer Pairs

DiaSorin Molecular has introduced three new primer pairs for Legionella species, Chlamydophila pneumoniae, and Mycoplasma pneumoniae, which can be used in laboratory-developed tests. The firm noted that it now offers more than 55 analyte-specific reagents.

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