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Apr 18, 2019

Quest Diagnostics STD Packages

Quest Diagnostics launched three sexually transmitted disease laboratory test packages that consumers can purchase online. The packages include tests for chlamydia and gonorrhea, trichomonas, hepatitis B and C, syphilis and human immunodeficiency virus, and are available in 45 states throguh QuestDirect, an online consumer-initiated testing service provided by Quest. Test results are available on MyQuest, the firm's patient portal. Quest noted that licensed physicians provide oversight of all lab tests, including ordering of the tests and evaluation of the results.

Apr 10, 2019

Thermo Fisher Scientific CEDIA Mitragynine (Kratom) Assay

Thermo Fisher Scientific launched the CEDIA Mitragynine (Kratom) Assay for laboratorians to test for the presence of kratom. The test, which is for criminal justice and forensic use only, includes supporting calibrators and controls, and can be run on commonly used clinical chemistry analyzers, Thermo Fisher said. 

Apr 08, 2019

Becton Dickinson BD Bactec Platelet Quality Control Media

Becton Dickinson launched its BD Bactec platelet quality control media, which allows microbilogy laboratories, blood banks, and transfusion services to identify contaminated platelet units, and reduce the risk of sepsis. The product is part of a package from BD leveraging the BD Bactec FX technology and BD Synapsys microbiology informatics solution to help labs meet culture-based platelet testing requirements. The BD Bactec platelet is FDA cleared and CE-IVD marked, and can be used for QC testing of leukocyte-reduced aspheresis platelet units, and both leukocyte-reduced single and a pool of up to six units of leukocyte-reduced whole-blood platelet concentrates, the firm said. 

Apr 05, 2019

Fabric Genomics Hereditary Panels With ACE

Fabric Genomics has launched Fabric Hereditary Panels with ACE (AI Classification Engine) software for variant interpretation and clinical reporting. ACE is an artificial intelligence inference engine that leverages deep gene and variant annotation, resulting in highly accurate American College of Medical Genetics variant classification. The software is embedded within the Fabric Enterprise platform for genomic analysis and reporting that delivers a complete sequence-to-clinical report workflow. ACE enhances the Fabric Enterprise platform, making ACMG classification even faster and easier, the company said. The new software is now available for many common genetic tests such as inherited cancer risk including BRCA1 and BRCA2, newborn screening, and CDC-Tier 1 and ACMG incidental findings testing.

Apr 02, 2019

Progenity Resura Prenatal Test for Monogenic Disease; Innatal Prenatal Screen

Progenity has launched the Resura prenatal test for monogenic disease, a customizable, noninvasive prenatal test (NIPT) for single-gene disorders. The test is available to families with known risk for monogenic disease such as cystic fibrosis, sickle cell anemia, and Tay-Sachs disease. The test, which was developed using droplet digital PCR, uses fetal cell-free DNA extracted from a sample of the mother's blood, and can be performed on disease-causing variants of all inheritance types, including recessive, dominant, and X-linked genetic mutations.

Progenity also announced improvements to its Innatal prenatal screen, a NIPT for chromosomal aneuploidies that now provides greater specificity and sensitivity in evaluating aneuploidy across all chromosomes. Specifically, the sequencing-based test has been enhanced in terms of detecting aneuploidies in chromosomes 21, 18, 13, X, and Y, the company said.

Apr 02, 2019

MDNA Life Sciences Endemetriosis Blood Test

MDNA Life Sciences has launch a blood test for endemetriosis. The firm said it is the first blood test for the indication and can detect the disease in up to 9 out of 10 cases. Test results can be available in a few days, allowing doctors to make earlier diagnostic decisions and treatment. According to the West Palm Beach, Florida-based company, its technology is based on using mitochondrial DNA mutations as biomarkers for a range of diseases. A clinical study published in Biomarkers in Medicine, it added, showed that newly identified biomarkers was able to detect endometriosis in blood samples, including in early stages. 

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. 

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