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May 28, 2020

Analytik Jena Biometra TRobot II and qTOWER³ Auto Thermal Cyclers

Jena, Germany-based life science firm Analytik Jena has introduced two new thermal cyclers. The Biometra TRobot II is a small footprint PCR module that can be used to save space in a robotic setup, while the qTOWER³ Auto is a qPCR thermal cycler useful for fully automated qPCR applications.

May 21, 2020

Indica Labs, Octo: COVID Digital Pathology Repository

Indica Labs and Octo launched the COVID Digital Pathology Repository, an online collection of high-resolution microscopic COVID-related human tissues hosted at the US National Institutes of Health. The repository enables international collaboration by providing a centralized, cloud-based repository for sharing and annotating digital whle-slide images of lung, liver, kidney, and heart tissues from patients who were infected with the SARS-CoV-2 coronavirus, as well as SARS and MERS. The images, annotations, and metadata will be used as a reference dataset for education, research, and future clinical trials. The repository is underpinned by Indica's Halo Link software, an image management platform. For the repository, Halo Link will be deployed in a web portal developed by Octo and Axle Informatics.

May 19, 2020

Aalto Bio Reagents Recombinant SARS-CoV-2 Spike Proteins

Dublin-based Aalto Bio Reagents has released a range of recombinant SARS-CoV-2 spike (S) proteins for diagnostic test manufacturers, vaccine developers, and researchers globally. The S protein is the main antigenic component that is responsible for inducing host immune responses and neutralizing antibodies, making it the principal focus of therapeutic and vaccine design for COVID-19. When used solely or in combination with Aalto's new insect-derived nucleocapsid protein (N), the company's S1-S2 chimeric glycoprotein has demonstrated excellent reactivity in ELISA for the detection of IgA, IgG and IgM antibodies against SARS-CoV-2, the company said.

May 18, 2020

Beckman Coulter DxH 690T Hematology Analyzer

Beckman Coulter announced the launch of its DxH 690T table-top hematology analyzer in the US. The instrument provides the benefits of the company's large-volume DxH 900 hematology analyzer for a mid-volume setting. The Brea, California-based company said the instrument streamlines throughput, minimizes reflex testing, and reduces manual interventions. Beckman Coulter's Early Sepsis Indicator, a biomarker cleared by the US Food and Drug Administration that can help clinicians detect patients with sepsis or at high risk for developing sepsis, is available on the new analyzer. 

May 11, 2020

LGC SARS-CoV-2 Verification Panel and Reference Materials; Charité ValuPanel Assay Reagents

LGC Seracare has launched new versions of its AccuPlex Verification Panel and Reference Material Kit for SARS-CoV-2 testing. The previous versions contained negative control material targeting the human RNase P gene and positive control material for the viral ORF1a, RdRp, E, and N gene consensus sequences targeted in the US Centers for Disease Control and Prevention and World Health Organization assays. They have now been expanded to include the S gene region of the virus. 

In addition, LGC Biosearch Technologies has launched new assays in its ValuPanel line. The Charité 2019-nCoV BHQ and BBQ-650 ValuPanel Reagent sets use oligonucleotide sequencedesigned by the German Center for Infection Research (DZIF) at Charité. The firm also now offers US CDC 2019-nCoV BHQ ValuPanel Reagents sets, and continues to offer the 2019-nCoV CDC-qualified Probe and Primer Kits for SARS-CoV-2.

May 01, 2020

CloudLIMS LIMS for COVID-19 Testing

Laboratory informatics provider CloudLIMS has launched its rapid deployment LIMS preconfigured for COVID-19 testing. The LIMS can be set up for SARS-CoV-2 testing in two to four days and comes preloaded with tests approved by the US Food and Drug Administration and US Centers for Disease Control and Prevention, as well as report templates and workflows to maximize testing and reporting capability of labs doing COVID-19 testing. 

May 01, 2020

Microbiologics SARS-CoV-2 RNA Process Control

Microbiologics has launched two new research-use-only products for COVID-19 research and quality control: a protein-coated RNA process control and an IVD control with pooled gene targets.

The new SARS-CoV-2 control features diagnostically relevant RNA sequences protected by phage protein, providing nuclease resistance even in nuclease-rich environments such as nasal secretions or plasma. This coating protects the RNA during the extraction process, preventing the false negatives that can occur with the use of naked RNA. The protein coating functions like the virus's protective envelope that sequesters and protects its RNA genome. Featuring genomic targets for all seven WHO COVID-19 testing protocols, this process control can be used for SARS-CoV-2 assay development, positive extraction, and spike-in controls.

The new SARS-CoV-2 Helix Elite control features a pool of large RNA molecules that match the viral sequences for the RdRp gene, S gene, E gene, and N gene. These pooled genetic targets offer broad compatibility with CDC- and WHO-specified test components to generate positive PCR signals.

Apr 29, 2020

ProteoGenix Human Immune COVID-19 Library

ProteoGenix has launched a Human Immune COVID-19 Library to facilitate the discovery of antibodies against SARS-CoV-2. Created using blood samples from dozens of recovered COVID-19 patients, the library is adapted for screening with phage display and features 1.2 x 1010 different clones. The phage display screening technology coupled with the library's diversity is expected to speed the discovery of antibodies with the strongest affinity, specificity, and viral blocking activity, the company said. ProteoGenix said that it also offers a broad diversity of ready-made SARS-CoV-2 antigens, as well as custom antigen development services. Within eight weeks, clients can receive three to 10 unique and royalty-free antibody sequences with optimal affinity.

Apr 28, 2020

LabVantage COVID-19 Biobanking Accelerator

LabVantage Solutions has introduced COVID-19 Biobanking Accelerator to help laboratories rapidly implement COVID-19 biobanking, testing, and research programs. Based on the existing LabVantage laboratory information management system, the COVID-19 Biobanking Accelerator can accommodate tests including reverse transcription PCR, isothermal nucleic acid amplification, and serology, according to Centers for Disease Control and Prevention or customer-specified testing protocols. The company said that new users can be live on the software-as-a-service platform in fewer than four weeks.

Apr 27, 2020

Meridian Bioscience Inhibitor Tolerant 1-Step RT-qPCR Mix

Meridian Bioscience launched its Inhibitor Tolerant 1-step RT-qPCR Mix, an enzyme master mix that eliminates the need for an RNA extraction kit before running a sample through a molecular assay. Meridian developed the master mix formulation because it said RNA isolation and purification is time consuming and expensive. The company also noted that RNA extraction kits have been in short supply during the COVID-19 pandemic. 

When combined with SARS-CoV-2 primers and probes, the proprietary master mix can be used by laboratories to eliminate RNA purification, reducing processing times by as much as 30 minutes and lowering test costs.  

Apr 27, 2020

Proscia: Concentriq Dx

Proscia has launched its Concentriq Dx digital pathology software in the US. The software can be used for reviewing and reporting digital pathology slides from remote locations, such as home offices, using an internet browser. Concentriq Dx was CE marked in November 2019. According to Proscia, Concentriq Dx will support the need for remote pathology in US during the coronavirus pandemic. The US Food and Drug Administration recently issued new guidance allowing the greater availability of remote digital pathology services during the pandemic. 

 
Apr 22, 2020

Skyline Dx: Merlin Assay

Skyline Dx launched the Merlin Assay for melanoma as a laboratory-developed test available through its CLIA/CAP facility in San Diego. According to the Rotterdam, Netherlands-based company, a recently published study found the test could reduce up to 42 percent of surgical interventions in patients diagnosed with melanoma. The assay was developed as a result of the Falcon R&D Program, a partnership between clinicians and academia to develop tools for optimizing the clinical pathway of melanoma patients. 

Apr 22, 2020

Centogene CentoSwab

Centogene has launched CentoSwab, a sample collection kit that is validated for pharyngeal sampling for the detection of SARS-CoV-2, the virus that causes COVID-19. The kit consists of a swab and a collection tube and will be distributed globally.

Apr 22, 2020

Caris Life Sciences MI Exome

Caris Life Sciences has launched MI Exome, a whole-exome next-generation sequencing-based assay.

The test covers 22,000 genes and detects point mutations, indels, copy number alterations, and about 250,000 exonic, intronic, and intergenic SNPs. MI Exome also includes analysis of tumor mutational burden, microsatellite instability, loss of heterozygosity, and homologous recombination deficiency, and can be used to interrogate bacteria, viruses and fungi, including cancer-related pathogens, to support microbiome analysis. Average turnaround time is less than 14 days. When paired with the Caris Molecular Intelligence profiling services, the test can help detect and characterize cancer to guide individualized treatment decisions, the company said.

Apr 21, 2020

Biocept RUO Target Selector Kits

Biocept has announced the availability of new research-use-only kits allowing molecular laboratories to perform some of its Target Selector molecular assays in house on both formalin-fixed paraffin-embedded tissue and circulating tumor DNA samples. The first available kits, for EGFR mutations, are being made available now and additional assays targeting other oncogene mutations are planned for launch in the future, Biocept said.
 
The firm's Target Selector technology platform utilizes patented "Switch-Blocker" technology to enrich specimens for specific mutations of interest, resulting in high assay sensitivity and specificity. According to the company, this high performance allows detection of minute fractions of mutated DNA in a liquid biopy sample, and could also allow laboratories to eliminate macro-dissection of tumor blocks or provide results with small DNA inputs compared to most tissue-based assays. Target Selector assays can be used in combination with a variety of low-cost analytical platforms including qPCR, Sanger sequencing, microarrays, and mass-spectrometry, in addition to next generation sequencing, the firm said. 
Apr 17, 2020

Randox: Qnostics SARS-CoV-2 Molecular Controls

Randox has launched whole pathogen molecular controls for SARS-CoV-2. The controls were developed by UK scientists and are being made available by Randox under the Qnostics brand name. The controls are for use to ensure accurate coronavirus test and system performance and are manufactured using whole pathogens to mimic the patient sample. The controls contain the entire SARS-COV-2 genome, incuding conserved regions recommended by the US Centers for Disease Control and Prevention and the World Health Organization, and they are compatible for use with commercial and in-house testing methods. 

Apr 16, 2020

Eurofins Genomics US SARS-CoV-2 Plasmid DNA Controls

Eurofins Genomics US and its subsidiary BlueHeron Biotechnology have launched three SARS-CoV-2 plasmid DNA controls for verifying the presence of the virus. The controls are intended for use in both R&D and diagnostic applications and target key segments in the virus genome. One of them, CVGP, covers a large part of the viral sequence.

Apr 15, 2020

Bio-Techne ExoDx Prostate Test At-Home Collection Kit

Bio-Techne has launched the Exosome Diagnostics ExoDx Prostate Test At-Home Collection Kit for patients who are concerned about their prostate health.

The ExoDx Prostate or EPI test is a urine-based genomic test that helps inform the prostate biopsy decision.

Due to shelter in place orders issued to reduce the spread of COVID-19, appointments have been cancelled for millions of men for important procedures such as biopsies to detect the presence of prostate cancer, the firm noted. The at-home collection kit enables physicians and their patients to employ a telehealth solution when patients share frustration, anxiety, and fear over whether they might harbor high-grade prostate cancer, Bio-Techne said.

Apr 10, 2020

Active Motif Recombinant COVID-19 Antibodies

Active Motif said that in February it successfully isolated antibodies from patients in China recovering from COVID-19, and that the full suite of antibodies is now available for research applications and diagnostic test development. In collaboration with Fudan University and its Public Health Clinical Center, the company used its proprietary single-cell AbEpic screening technology to isolate the antibodies from patients, whose samples were screened to obtain whole human IgG antibody clones that have been sequenced, expressed, and characterized for binding directly to the SARS-CoV-2 S1 protein.

Apr 10, 2020

Codex Synthetic DNA Products for COVID-19 Research; Dx/Vaccine Development

Codex has launched a number of newly developed products and services for COVID-19 research and diagnostic/vaccine development. The new products include:

  • SARS-CoV-2 diagnostic RNA controls: safe positive controls that replace the need for live virus in RT-PCR and NGS testing protocols
  • SARS-CoV-2 antigen panels and antibody libraries: allow for rapid design and iteration of antigens or antibody libraries for the development of vaccines and therapeutics using the company's BioXp 3200 gene automated synthesis platform.
  • SARS-CoV-2 spike protein DNA vaccine construct, mRNA vaccine scaffold, and live attenuated vaccine scaffold for vaccine development
  • SARS-CoV-2 synthetic DNA parts: span the whole genome and useful for developing DNA, RNA, and viral vector vaccines and pan-genome diagnostics
  • SARS-CoV-2 full-length synthetic genome: the Wuhan-Hu-1 strain of SARS-CoV-2 cloned in a bacterial artificial chromosome for the development of vaccines, therapeutics, and diagnostics.
Apr 06, 2020

Verichem Laboratories: Enzyme ER Verifier Kits

Verichem Laboratories launched the Enzyme ER Verifier Kits, a ready-to-use, liquid stable product for the calibration verification of wet chemistry testing systems. The kit is a multianalyte, six-layer verifier kit of liquid stable materials. It comprises nine separate clinical enzyme components and covers 54 individual activities.

Apr 03, 2020

AmpTec Universal COVID-19 Positive Control IVT RNA EURM-019

AmpTec has released a Universal COVID-19 Positive Control IVT RNA, called EURM-019, to facilitate quality control of the detection of SARS-CoV-2 at core facilities and hospital laboratories. The EURM-019 material consists of single-stranded RNA fragments of the SARS-CoV-2 genome and can also serve as a benchmark to validate SARS-CoV-2 RT-PCR tests kits in development. AmpTec is supplying the control on behalf of the European Commission.

Apr 03, 2020

Thermo Fisher Scientific AcroMetrix Coronavirus 2019 (COVID-19) RNA Control

Thermo Fisher Scientific has launched the Thermo Scientific AcroMetrix Coronavirus 2019 (COVID-19) RNA Control to help validate and monitor COVID-19 molecular diagnostic tests. The non-infectious positive control consists of synthetic RNA transcripts containing the N, S, E, and Orf1ab regions of the SARS-CoV-2 genome. The RNA is ready for reverse transcription, PCR amplification, and detection. The kit contains two vials of RNA at concentrations that will result in low-positive and ultra-low-positive results in most commonly used PCR-based testing methods. The control is available globally as a research-use-only product and is not intended for clinical use.

Apr 03, 2020

Agilent K6460S Clinical Edition TQ LC/MS System

Agilent this week launched the K6460S Clinical Edition TQ LC/MS system, a triple quadrupole liquid chromatography/mass spectrometry system designed to improve in vitro diagnostic workflows in clinical labs. The system is listed as a Class I medical device with the US Food and Drug Administration and includes the clinical edition of Agilent MassHunter software to enable an easy and intuitive submission-to-reporting workflow. TQ LC/MS increases the specificity, selectivity, and accuracy of many clinical diagnostic assays compared to traditional binding assays, Agilent noted in a statement. The platform also received approval from China's National Medical Products Administration in January.

Apr 03, 2020

SensID Control Materials for Qiagen Therascreen PIK3CA RGQ PCR Kits

SensID, a Germany-based provider of controls and reference materials for clinical genomics, has introduced a set of controls for Qiagen's US Food and Drug Administration-approved and CE-IVD marked Therascreen PIK3CA RGQ PCR kits. Qiagen's kit was launched in Europe in February 2020 to aid in the identification of activating PIK3CA mutations in FFPE or blood plasma samples from patients with advanced breast cancer. The kit received FDA approval in 2019 and has been commercialized in the US as a companion diagnostic test for alpelisib (Novartis' Piqray).

SensID and Qiagen collaborated to develop the new control materials, which include 11 clinically actionable PIK3CA mutations estimated to be present in approximately 40 percent of HR+/HER2- advanced breast cancer cases and to confer a greater likelihood of responding positively to PI3K inhibitors. The control set contains seven vials (DNA in buffer) in a format matched to the reaction mixes of the Therascreen kit, and each set provides sufficient materials for about 40 runs, the company said. SensID also offers certified DNA-free human plasma that can be used in conjunction with the sample set, if suitable plasma is not available locally.

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