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Tag Archives: Thermo Fisher Scientific

FDA clears Thermo Fisher chromogranin A assay

November 2023—Thermo Fisher Scientific announced FDA clearance of its Thermo Scientific Brahms CgA II Kryptor, an automated immunofluorescent assay for the quantitative determination of the concentration of chromogranin A in human serum. The biomarker is to be used in conjunction with other clinical methods as an aid in monitoring disease progression during the course of disease and treatment in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NET), grades 1 and 2.

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Thermo Fisher launches TrueMark infectious disease panels

January 2023—Thermo Fisher Scientific launched its TrueMark Infectious Disease Research Panels. The analytically sensitive, duplexed TaqMan assays are performed on pre-spotted and dried-down plates that include microorganism‑specific pathogens, using real‑time PCR techniques, which enables rapid and accurate detection for investigating microorganisms that cause respiratory, vaginal, urinary, gastrointestinal, and sexually transmitted diseases. The predefined and customizable panel options allow researchers to choose from more than 90 different bacterial and viral strain assays to generate results within four hours of taking the samples. Testing can be done from nasopharyngeal swabs or nasopharyngeal aspirate; vaginal, genital, and lesion swabs; or urine samples.

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Thermo Fisher liquid biopsy assays

February 2023—Thermo Fisher Scientific has introduced more than 50 Absolute Q liquid biopsy assays for research use. The wet lab verified liquid biopsy assays provide highly sensitive, specific nucleic acid quantification, enabling single nucleotide polymorphisms detection down to 0.1 percent variant allele frequency.  

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FDA grants EUA for Thermo Fisher monkeypox test

February 2023—Thermo Fisher Scientific announced the FDA has granted emergency use authorization for its Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA kit, a polymerase chain reaction test designed to detect non-variola orthopoxviruses, including monkeypox virus, in approximately three-and-a-half hours. The test is intended for the qualitative detection of DNA from monkeypox virus (clades one and two) and screening for non-variola orthopoxviruses in human lesion swab specimens from patients suspected of monkeypox infection by their health care provider. The test is for in vitro diagnostic use.  

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Thermo Fisher Scientific buys Binding Site

November 2022—Thermo Fisher Scientific announced it has entered into a definitive agreement to acquire the Binding Site Group from a shareholder group led by European private equity firm Nordic Capital. The all-cash transaction is valued at approximately $2.6 billion at current exchange rates, Thermo Fisher reported in a press release.

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Oncomine Dx Target test approved to ID patients for Retevmo

Sept. 28, 2022—The FDA has approved Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to aid in selecting patients with RET-fusion positive locally advanced or metastatic non-small cell lung cancer, RET-fusion positive advanced or metastatic thyroid cancer, and RET-mutation positive advanced or metastatic medullary thyroid cancer who may be eligible for treatment with Lilly’s Retevmo (selpercatinib).

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CE-IVD-marked TaqPath respiratory viral panel

August 2022—Thermo Fisher Scientific has launched its Applied Biosystems TaqPath Respiratory Viral Select panel. The CE-IVD-marked molecular assay panel provides results in approximately three hours and tests for adenovirus, human metapneumovirus, rhinovirus/enterovirus, and parainfluenza virus using PCR technology. RNase P and positive controls are included to offer sample-to-result reliability. The solution is scalable, allowing laboratories to run from one to 94 samples simultaneously.

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NGS-based CDx approved to ID candidates for Enhertu

Aug. 16, 2022—The FDA granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target test as a companion diagnostic to identify patients whose tumors have HER2 (ERBB2)-activating mutations (single nucleotide variants and exon 20 insertion) in non-small cell lung cancer who may be candidates for Enhertu (fam-trastuzumab deruxtecan-nxki).

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Thermo Fisher RT-LAMP tests for ID surveillance

April 2022—Thermo Fisher Scientific has launched two reverse transcription loop-mediated isothermal amplification (RT-LAMP)–based solutions for research use only. The Invitrogen Colorimetric ReadiLAMP Kit, SARS-CoV-2, is an off-the-shelf assay designed to provide accurate, robust detection of SARS-CoV-2 from saliva, nasal, or nasopharyngeal swab samples. The kit includes two protocols, one for crude sample types with a 30-minute turnaround time and one for increased sensitivity with purified RNA sample types that has a one-hour turnaround time.

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TaqMan panel updated to include mu strain

November 2021—Thermo Fisher Scientific has updated its research use only Applied Biosystems TaqMan SARS-CoV-2 Mutation Panel to include the mu strain. Laboratories can build their own panel from a menu of more than 50 verified real-time PCR assays that allows the user to identify relevant SARS-CoV-2 mutations and adapt as additional mutations and variants emerge.

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Thermo Fisher launches TaqPath COVID-19 2.0 test

July 2021—Thermo Fisher Scientific launched its CE-IVD-marked TaqPath COVID-19 Fast PCR Combo Kit 2.0. The kit uses an advanced assay design that compensates for current and emerging variants, the company says, by using eight targets across three genomic regions of the virus to help ensure the test provides accurate results even as the virus mutates.

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Cascadion system launched with vitamin D test

May 2020—Thermo Fisher Scientific announced that its Cascadion SM clinical analyzer is commercially available in the U.S. with the Cascadion SM 25-Hydroxy Vitamin D assay. The Cascadion system analyzes samples directly from qualified primary blood collection tubes. The Cascadion SM 25-Hydroxy Vitamin D Assay incorporates fully barcoded components, all traceable to a specific result.

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Thermo Fisher digital dispensers

April 2020—Thermo Fisher Scientific launched the Thermo Scientific Multidrop Pico 1 and Pico 8 Digital Dispensers, designed to enable assay miniaturization, boost productivity, and improve accuracy of results. The systems dispense reagent volumes between 11 pL and 200 µL in any well and are suitable for a broad array of low-volume applications, including quantitative polymerase chain reactions, dose response curves, drug screening assays, serial dilutions, genotyping reactions, and enzyme-linked immunosorbent assays.

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Thermo Fisher launches genotyping workflow

March 2020—Thermo Fisher Scientific launched the Applied Biosystems Axiom Propel Genotyping workflow designed to allow laboratories to scale up easily by eliminating the need for multiple liquid handlers and lower running costs through the use of reusable dispensing cassettes and minimal labware.

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Thermo Fisher introduces Ion Torrent Genexus System

Nov. 22, 2019—Thermo Fisher Scientific launched at the Association for Molecular Pathology annual meeting the Ion Torrent Genexus System. The integrated, next-generation sequencing platform features an automated specimen to report workflow with 10 minutes hands-on time, two user touchpoints, and a turnaround time of one day.  

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Microbroth dilution plates for AST

November 2019—Thermo Scientific’s Sensititre Gram Negative MDRGN1F AST Plate is now available on the Sensititre AST System. This format offers eravacycline, omadacycline, and plazomicin on an FDA-cleared, IVD-labeled microbroth dilution susceptibility plate for antimicrobial susceptibility testing using second-line multidrug-resistant organism therapies with expanded dilution ranges for Gram-negative organisms.

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Thermo Fisher offers plazomicin immunoassay

February 2019—Thermo Fisher Scientific received FDA clearance for its de novo submission of its QMS Plazomicin Immunoassay. This quantitative immunoassay measures the concentration of a novel therapeutic antibiotic, plazomicin, using the Beckman Coulter AU 680 automated clinical chemistry analyzer. Plazomicin (Zemdri, Achaogen) is a next-generation aminoglycoside being used to treat patients with complicated urinary tract infections.

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Thermo Fisher acquires IntegenX, 5/18

May 2018—Thermo Fisher Scientific has acquired IntegenX, a forensic DNA testing firm. IntegenX products include the RapidHIT platforms, software analysis tools, and related consumables that are compatible with Thermo Fisher’s short tandem repeat chemistries for human identification.

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Thermo Fisher expands Oncomine portfolio, 4/18

April 2018—Thermo Fisher Scientific has expanded its Oncomine portfolio with two assays for liquid biopsy and immuno-oncology for clinical research. The company also announced its next-generation Ion AmpliSeq HD technology. The Ion Torrent Oncomine Pan-Cancer Cell-Free Assay enables reproducible detection and analysis of tumor DNA and RNA across all major classes of somatic mutations (SNVs, indels, CNVs, and fusions) from a single vial of blood, with as little as 1 ng of nucleic acid input, within two days.

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Thermo Fisher unveils line of NGS instruments, 3/18

March 2018—Thermo Fisher Scientific announced the Ion GeneStudio S5 Series, a line of benchtop next-generation sequencing instruments that provides flexibility and scalability enabled by five Ion S5 chips, including the new Ion 550 chip, on a single platform. Research applications include cancer, inherited disease, and microbial and infectious diseases.

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DNA purification reagents, 2/18

February 2018—Thermo Fisher Scientific released its MagMax DNA Multi-Sample Ultra 2.0 reagents, which provide genetic testing companies, labs, and service providers with high-throughput DNA extraction from blood, saliva, buffy coat, and buccal swabs. The next-generation reagents can purify DNA from 96 samples in 45 minutes on Thermo Scientific KingFisher instruments using a simplified protocol for either small- or large-volume sample input.

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Cell washer, 11/17

November 2017—The CW3 Cell Washer, from Thermo Scientific, is an FDA-cleared, fully automated, high-performance cell washer designed to enable precise, thorough, reproducible, and rapid blood cell washing of up to 24 tubes in a three-minute run.

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Thermo Scientific leakproof vials, 10/17

October 2017—Thermo Scientific Samco Clicktainer leakproof vials have been developed to provide sample protection and user safety by enabling correct cap application. The vials are designed for the secure collection and handling of fluid, solid, and powder samples, including urine, sputum, and stool specimens; the lid-lock design makes them ideal for the secure transport of clinical, research, and forensic samples.

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Asuragen, Thermo Fisher collaboration, 5/17

May 2017—Asuragen entered into a collaboration agreement with Thermo Fisher Scientific for the development and commercialization of capillary electrophoresis-based in vitro diagnostics. Asuragen will leverage its AmplideX PCR/CE product technologies to develop diagnostic kits for the 3500 Dx Series Genetic Analyzer CS2 instrument.

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Clariom assays, 1/17

January 2017—Thermo Fisher Scientific’s two Clariom brand of assays, Clariom D Pico and Clariom S Pico, are designed primarily for translational researchers to accelerate the discovery and validation of complex biomarker signatures derived from coding and noncoding RNA across the whole transcriptome. Based on industry-leading microarray technology, the Clariom Pico assay designs include up-to-date content curated from a large number of public sequence databases, including RefSeq, Noncode, Ensembl, VEGA, lncRNAWiki, and RNA Central, among others.

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PCR master mix, 11/16

November 2016—Thermo Fisher Scientific launched the Applied Biosystems TaqPath ProAmp PCR Master Mix. The mixes are developed for high-throughput genotyping and copy number variation protocols requiring accurate results from samples containing PCR inhibitors and are designed to deliver sensitive and reproducible results from genomic DNA targets.

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Hydrocodone, Brahms PCT assays, 10/16

October 2016—Thermo Fisher Scientific exhibited its expanded offering of new assays, instruments, and software designed specifically for customers working in research and clinical settings. The Thermo Scientific DRI Hydrocodone assay detects hydrocodone in specimen samples and is FDA 510(k) cleared.

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NGS assay, 9/16

September 2016—The Oncomine Lung Cell-Free DNA Assay from Thermo Fisher Scientific is designed to target mutations in non-small cell lung cancer samples derived from circulating cfDNA in blood.

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Blood banking centrifuges, 9/16

September 2016—Thermo Scientific introduced two large-capacity blood banking centrifuge models. For regular- to medium-throughput blood processing needs, the Sorvall BP 8 and Heraeus Cryofuge 8 centrifuges provide 6 × 550 mL blood bag capacity and, using the same bucket system, are upgradeable to 8 × 550 mL bags.

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Reverse transcriptase kit for RT-qPCR, 7/16

July 2016—Invitrogen SuperScript IV VILO Master Mix from Thermo Fisher Scientific is a cDNA reaction master mix designed for two-step quantitative PCR (RT-qPCR) applications. The master mix format uses variable input, linear output technology and combines optimized buffer conditions with Invitrogen SuperScript IV reverse transcriptase.

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Autoimmune thyroid disease tests, 6/16

June 2016—Thermo Fisher Scientific received 510(k) clearance for two new EliA IgG tests for detecting anti-thyroglobulin and anti-thyroid peroxidase autoantibodies in serum or plasma. The CLIA-moderate laboratory tests are performed on the fully automated Phadia 250, 2500, and 5000 laboratory systems.

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Benchtop centrifuge, 3/16

March 2016—The Thermo Scientific Medifuge is a benchtop centrifuge that features a two-in-one hybrid rotor with interchangeable fixed-angle and swinging buckets to facilitate quick and convenient switching between applications. When coupled with the Thermo Scientific DualSpin rotor, the centrifuge provides the flexibility to perform several applications on a single platform.

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Hydrocodone assay receives 510(k) clearance, 12/15

December 2015—Thermo Scientific’s DRI Hydrocodone Assay received FDA 510(k) clearance; it also has the requisite sensitivities to meet the newly proposed Substance Abuse and Mental Health Services Administration guidelines (using a 300 ng/mL cutoff). SAMHSA oversees the testing of federally regulated employees, and many organizations follow the guidelines set forth by this agency.

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Newsbytes, 8/15

August 2015—How one pathologist made use of artificial intelligence: Like many pathologists, Jay J. Ye, MD, PhD, longed to spend less time preparing reports and more time interpreting slides and rendering diagnoses. Rather than dedicating half of his workday to what he considers secretarial tasks, the dermatopathologist wanted to devote the lion’s share of his hours in the lab toward applying the knowledge and skills he developed during his years of medical training and practice.

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Mass spectrometer, software solutions, 7/15

July 2015—Thermo Fisher introduced the Thermo Scientific Orbitrap Fusion Lumos Tribrid Mass Spectrometer, the newest addition to its line of Orbitrap Tribrid mass spectrometers. Designed to expand researchers’ capabilities in advanced proteomics and metabolomics applications, including targeted, data-independent acquisition and top-down analyses, the Orbitrap Fusion Lumos Tribrid has a high level of sensitivity, delivering complete protein sequence coverage and allowing scientists to perform more inclusive analyses.

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Horizon, Thermo Fisher agreement, 6/15

June 2015—Horizon Discovery Group has signed a supply and commercialization agreement with Thermo Fisher Scientific. Under the terms of the agreement, Thermo Fisher will market and distribute Horizon’s X-MAN human haploid and diploid isogenic cell line collection and will further offer the X-MAN haploid cell line generation service to its worldwide customer base.

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Thermo Fisher Scientific and Samsung collaborate, 5/15

May 2015—Thermo Fisher Scientific and Samsung Electronics have formed a strategic collaboration to jointly design, develop, and market new point-of-care solutions in key applications, such as the detection of sepsis, drugs of abuse, and therapeutic drug monitoring as well as the detection of cardiac problems and women’s health conditions.

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RNA fusion lung cancer research panel, 4/15

April 2015—Thermo Fisher Scientific has released a next-generation sequencing RNA panel and workflow that enables targeted sequencing of fusion transcripts for clinical research. The Ion Torrent AmpliSeq RNA Fusion Lung Cancer Research Panel allows simultaneous sequencing of 70 ALK, RET, ROS1, and NTRK1 fusion transcripts associated with lung cancer as well as 5’ and 3’ ALK gene expression.

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CE-IVD tumor panel for NGS, 3/15

March 2015—The CE-IVD Oncomine Solid Tumor DNA kit from Thermo Fisher Scientific enables accurate and reliable multiplexed sequencing of formalin-fixed, paraffin-embedded tumor. Based on the Ion Torrent AmpliSeq technology, the kit allows detection of single nucleotide somatic changes, inversions, insertions, and deletions using as little as 10 ng of FFPE DNA ...

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Thermo Fisher, Cynvenio distribution agreement, 2/15

February 2014—Thermo Fisher Scientific has signed an agreement with Cynvenio Biosystems, a molecular testing company focused on the genomic analysis of tumor biomarkers in the bloodstream, for rights to distribute its LiquidBiopsy platform. The automated LiquidBiopsy platform is designed to extract and isolate circulating tumor cells from a standard blood draw in preparation for high-content imaging and genomic analysis.

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Immunoassays for hydrocodone detection

January 2015—Thermo Fisher Scientific launched its DRI Hydrocodone/Hydromorphone Assay, a homogeneous enzyme immunoassay that specifically detects hydrocodone and major metabolites in human urine at a 300 ng/mL cut-off. The assay uses liquid ready-to-use reagents, calibrators, and controls and can be run in qualitative and semiquantitative modes.

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Orbitrap-based mass spectrometer, 12/14

December 2014—Laboratories performing food and environmental testing, clinical research, forensic toxicology, pharmaceutical or biopharmaceutical measurements, and other applied analyses can now benefit from the performance of high-resolution accurate-mass (HRAM) Orbitrap mass spectrometry using an instrument designed for cost-per-sample-sensitive workflows.

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Blast freezers, 12/14

December 2014—The Thermo Scientific XBF40 series of -40°C blast freezers are for rapid cooling during the sample preparation process, prior to freezer storage. Available in two options, the XBF40D-MD is designed for rapid plasma freezing and accommodates plasma bags, boxes, and bottles, and the XBF40D is for general-purpose applications and accommodates staggered loads and a variety of vessels, such as carboys, bottles, racks with vials, and more.

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NGS system CE marked for IVD use, 12/14

December 2014—Thermo Fisher Scientific announced the successful CE-IVD registration of its Ion PGM Dx System for sale in European countries. The system was developed using the Ion Torrent next-generation sequencing technology, currently used in clinical research laboratories to produce tests to uncover meaningful genetic information for a range of human conditions.

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NGS oncology quality control, 11/14

November 2014—Clinical laboratories running next-generation sequencing oncology tests now have access to a universal quality control material compatible with multiple sequencing platforms. The AcroMetrix Oncology Hotspot Control from Thermo Fisher Scientific provides a common quality control material that can be used in laboratories with different NGS instrument platforms, assays, and bioinformatics pipelines to test precision and detect analytical deviations that may arise from reagent and instrument variation.

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Electronic pipettes, 8/14

August 2014—E1-ClipTip electronic pipettes from Thermo Fisher Scientific are designed to maintain precise sample volumes on every channel with fewer repetitions and reproducible results for multiple application types. The ClipTip technology, electronic tip ejection, intuitive personalized user interface, and adjustable tip spacing for sample transfers make the E1-ClipTip pipette an optimal solution for complex and demanding protocols.

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Refrigerated benchtop centrifuge, 8/14

August 2014—Thermo Fisher Scientific’s refrigerated small benchtop centrifuges separate samples in a compact footprint and run a wide range of applications. The refrigeration system provides a temperature range of -10°C to -40°C and can maintain temperatures when the chamber is not in use.

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High-performance centrifuge system, 7/14

July 2014—Designed to improve productivity and ensure sample safety and integrity, the Thermo Scientific Sorvall RC BIOS 10 centrifuge system accommodates a range of cell culture and bioprocessing applications. The company’s Fiberlite F5-10x1000 LEX carbon fiber rotor spins up to 10 one-liter Nalgene centrifuge bottles in a single run. The system’s large capacity and design suits numerous applications, including bacterial and mammalian cell pelleting, pelleting of cell cultures from fermentation tanks, large microbial cultures, biologics and vaccine production, clarifying broths, and harvesting cell and tissue cultures.

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Water purification system, 9/13

Thermo Fisher Scientific has launched its Barnstead GenPure xCAD Plus water purification system, which has technology that allows simultaneous dispensing from three remote dispensers for exceptional flexibility and ease of use in shared laboratory environments. In addition to its advanced dispensing technology, the Barnstead GenPure xCAD Plus is easy to use and comes with leak detection, feed water monitoring, and ...

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LC-MS system, 7/13:109

Thermo Fisher Scientific’s Orbitrap Fusion Tribrid liquid chromatography-mass spectrometry (LC-MS) system combines its quadrupole, Orbitrap, and linear ion trap mass analyzers in a “Tribrid” architecture that analyzes complex biological samples.

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Spectrometer, 5/13:85

Thermo Fisher Scientific’s iCAP 7000 series ICP-OES (inductively coupled plasma optical emission spectrometer) is driven by Qtegra Intelligent Scientific Data Solution (ISDS) software. The platform, designed to streamline workflows and minimize cost per sample, facilitates trace elemental analysis in pharmaceutical, environmental, industrial, and food and beverage analysis applications.

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Cryopreservation reagents, 3/13:74

Thermo Fisher Scientific has expanded its suite of cryopreservation reagents with the HyClone HyCryo and HyCryo-Stem cryopreservation media, enabling researchers to maximize the preservation, recovery, and growth of post-thaw cells for general cell culture and stem-cell applications.

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