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Apr 02, 2019

PerkinElmer, Helix GenePrism:Actionable Insights

PerkinElmer and Helix have launched GenePrism:Actionable Insights, a genetic screening test that they said is the "most comprehensive clinical grade DNA sequencing and interpretation" test currently on the market. The test allows users to learn about their risk for underlying diseases. A user's DNA will be sequenced by Helix and the results will be interpreted by board-certified geneticists at PerkinElmer Genomics using ordered data interpretation network, that firm's proprietary high-throughput software platform. In comparison to other commercial firms that look at a limited number of letters in a gene sequence, GenePrism:Actionable Insights assesses each of 59 genes in its entirety, including BRCA1/2, the partners said. They also noted that PerkinElmer Genomics maintains one of the largest databases of known genetic variations from different ancestries globally providing customers with a more in-depth assessment. 

Mar 21, 2019

Roche Diagnostics Navify Mutation Profiler, Navify Therapy Matcher

Roche Diagnostics has launched Navify Mutational Profiler and Navify Therapy Matcher to support next-gen sequencing-based cancer genomic profiling tests. Both are part of Roche's Navify Decision Support portfolio.

Navify Mutational Profiler is a clinical software that provides annotation, interpretation, and clinical reporting of NGS tests. Navify Therapy Matcher is an optional clinical decision support app that helps clinicians link clinically actionable mutations to therapy options.

Mar 21, 2019

Beckman Coulter Access PCT Assay

Beckman Coulter has launched its Access PCT assay, which helps physicians assess the risk of critically ill patients progressing to severe sepsis or septic shock. Test results, the firm said, are availalbe in less than 20 minutes. The test allows physicians to integrate procalcitonin testing analysis into their routine sepsis workups on core lab analyzers, it added, as a primary or reflex test programmed through Beckman Coulter's Remison Advance middleware, simplifying the lab workflow and optimizing institutional sepsis management protocols. The Access PCT assay received CE marking in late January, a company spokesperson said, and is available for use on the Access Family of Immunoassay Systems, including the Access 2, UniCel DxI 600, and UniCel DxI 800. 

Mar 19, 2019

Strata Oncology StrataNGS

Strata Oncology has launched version 3.0 of StrataNGS, its pan-cancer assay for solid tumors. The updated 500-gene assay sequences DNA and RNA from tumor samples to detect all clinically actionable biomarkers — including microsatellite instability, tumor mutational burden, and PD-L1 — recommended by leading guidelines, in a single test. Test results are provided in a streamlined report that facilitates interpretation and identification of potential treatment options and clinical trials, Strata said.

Mar 14, 2019

Numares Glomerular Filtration Rate Test

Numares announced the global launch of its latest test in the Axinon family, the Clearance Check, used for the assessment of the glomerular filtration rate — how much blood the kidneys filter each minute. The serum test provides the accuracy of tracer-based plasma clearance methods, the firm said. The new test is based on a metabolite constellation analyzed by a technique called magnetic group signaling combined with nuclear magnetic resonance spectroscopy.

Mar 14, 2019

Shield Diagnostics Target-NG

Shield Diagnostics, a CLIA-certified clinical laboratory based in San Jose, California, has launched Target-NG, a rapid molecular test for antibiotic susceptibility in Neisseria gonorrhoeae. The test, which users can run on urine, rectal, and pharyngeal samples, can determine if a given gonorrhea infection is susceptible to ciprofloxacin with the same turnaround time as standard gonorrhea screening tests, the company said.

Mar 14, 2019

Lonza Lucetta 2 Luminometer

Lonza has launched the Lucetta 2 Luminometer, a single-tube system for simplifying and accelerating mycoplasma detection in cell cultures. The instrument can be used to run Lonza's MycoAlert Mycoplasma Detection Assays with results available within 20 minutes, the firm said. 

Mar 07, 2019

LGC, Biosearch Technologies RapiDxFire Thermostable RT

LGC, Biosearch Technologies has launched RapidDxFire Thermostable RT, a thermostable reverse transcriptase designed specifically for diagnostic kit developers. The enzyme's optimum temperature of 55° C to 80° C improves reaction specificity and allows synthesis from diverse RNA templates. It also has a reaction time of five minutes or less, and is recommended for targets under 1 kb. Its extended stability at room temperature make it compatible with automation, and the enzyme is available in a lyophilization-ready Triton X-100-free format, the company said.

Feb 25, 2019

Medical Database LDS, LDS Analytics

Medical Database introduced two new clinical laboratory decision support products, LDS and LDS Analytics. The LDS platform helps clinicians choose and order appropriate diagnostic tests according to diagnosis, symptoms, and ICD-10 codes to assure that the tests meet payor "medical necessity" guidelines. The LDS Analytics product is an enterprise analytics system to check every claim for medical necessity and assure that the provider has included the most appropriate CPT or ICD-10 code for maximum reimbursement.

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. 

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