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Enzo Biochem p16

Jan 22, 2018

Enzo Biochem launched its p16 cervical cancer biomarker detection test. The test, the firm said, is the latest addition to its immunohistochemistry pipeline, which includes Ki-67, HER2, and p53. The validated p16 test allows for the detection of tissue abnormalities in cancer, including cervical cancer, and it complements Enzo Biochem's Polyview line of immunohistochemistry detection products, the company said. 

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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.