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New Products Posted to GenomeWeb: Foundation Medicine, Cepheid, Thermo Fisher, Olink, More

Foundation Medicine FoundationReport+

Foundation Medicine has launched FoundationReport+, a new interactive digital report intended to aid users in their interaction with the company's comprehensive genomic profiling (CGP) results. Accessible through the Foundation Medicine online portal, the new digital reporting tool is customizable to user preference and allows healthcare providers to control the depth of information they would like to see. As an adaptable system, the reporting platform has the potential to evolve in reflection of changes in clinical practice, the company said.

Cepheid Xpert GBS LB XC and Xpert Xpress MVP

Cepheid has launched its Xpert GBS LB XC test to qualitatively detect Group B Streptococcus (GBS) from enriched Lim broth cultures of patient samples. The new assay builds on Cepheid's previous Xpert GBS LB test launched in 2012 by adding another target. The new molecular test includes dual targets in highly conserved regions of the GBS genome to improve coverage and performance, Cepheid said in a statement. The test can provide positive results in 27 minutes and negative results in 43 minutes.

Cepheid has also launched its Xpert Xpress MVP test, a multiplexed PCR test to detect DNA from organisms associated with bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis from a single vaginal swab sample. The test returns results in an hour and runs on Cepheid's GeneXpert systems.

Thermo Fisher Scientific Rapid RT-PCR Accula Flu A/Flu B Test

Thermo Fisher Scientific has released the RT-PCR Accula Flu A/Flu B Test, a rapid, point-of-care RT-PCR test that enables healthcare providers to detect and differentiate influenza A and B in about 30 minutes. The test runs on the palm-sized, portable Accula Dock, which plugs into a standard wall outlet to enable RT-PCR testing without the need for a specialized laboratory, the company said. Thermo Fisher acquired Mesa Biotech, the company that developed and commercialized the Accula platform, in 2021. The Accula Dock and Accula Flu A/Flu B test received 510(k) clearance and CLIA waived status in 2018 from the US Food and Drug Administration.

Olink Flex

Olink has launched its Flex product, which allows researchers to create custom panels measuring up to 21 human proteins with absolute quantification. Users can select prevalidated assays from a catalogue spanning more than 200 human protein biomarkers covering biological pathways including inflammation, immuno-oncology and oncology, neurology, and cardiovascular disease. Flex panels are compatible with Olink's Signature Q100 instrument.

Juno Diagnostics Juno Hazel

Juno Diagnostics has launched Juno Hazel, a noninvasive prenatal screening test that uses blood from a finger prick. The assay makes use of JunoDx's proprietary sample collection kit and does not require phlebotomy. It tests for common chromosomal aneuploidies, including trisomy 21, 18, and 13, and promises greater than 99 percent sensitivity and specificity.

Cytek Biosciences Cytek Cloud

Cytek Biosciences has launched Cytek Cloud, a cloud-based platform that features two integrated tools (Panel Builder and Experiment Builder) to streamline workflows on Cytek's cell sorters and analyzers including Northern Lights, Aurora, and Aurora CS. Cytek Cloud combines all of Cytek's spectral panel design tools in one place and enables users to prepare experiments remotely prior to accessing the instrument.

Sony SFA – Life Sciences Cloud Platform

Sony has launched the SFA – Life Sciences Cloud Platform, cloud-based flow cytometry data analysis software that can perform a wide array of analysis protocols from conventional analyses like gating to advanced analyses such as dimensionality reduction. The platform is compatible with Sony's flagship ID7000 spectral cell analyzer, which can deliver streamlined multicolor cell analysis with more than 44 colors, Sony said. Raw data output and analysis results from the ID7000 software can be directly imported and analyzed without any conversion. In addition, the new product features BL-FlowSOMiv, a newly developed algorithm that speeds up FlowSOM, one of the clustering methods, Sony said.

MRC Holland SALSA Digital MLPA Probemixes for Multiple Myeloma and Acute Lymphoblastic Leukemia

MRC Holland has launched two new research-use-only assays for hematological malignancies: SALSA Digital MLPA Probemix D006 Multiple Myeloma and SALSA DigitalMLPA Probemix D007 Acute Lymphoblastic Leukemia.

The multiple myeloma panel targets all non-acrocentric chromosomal arms to enable the detection of large copy number alterations and ploidy changes. Chromosomal regions that are frequently altered in multiple myeloma, including 1q, 1p, 13q, and 17p, are especially well-covered, allowing for high-resolution screening of these arms. The assay also covers genes of emerging significance, such as BCMA and GPRC5D, MRC Holland said.

The ALL assay has been specifically developed to increase the genomic coverage of ALL-related regions, making it possible to include all the targets from ALL-relevant SALSA MLPA Probemixes and more in one assay. A single reaction is enough to simultaneously screen for numerous ALL-related alterations, such as intragenic copy number alterations (e.g. IKZF1del), aneuploidies (e.g. 5q deletion), whole chromosome gains, losses and amplifications (e.g. iAMP21), gross ploidy changes (e.g. high hyperdiploidy), and intrachromosomal gene fusions (e.g. STIL-TAL1 fusion), the company said. In addition, this panel includes probes that target subtelomeric, pericentromeric, and middle regions of most chromosomal arms. This allows the detection of larger copy number alterations and ploidy status (hyperdiploidy and hypodiploidy).

Both panels are based on MRC Holland's SALSA DigitalMLPA technology, which merges the MLPA method with next-generation sequencing. Both assays are available worldwide, a company spokesperson said.

MGI Tech MGISP-Smart 8 Automated Sample Preparation System

MGI Tech has released the MGISP-Smart 8 automated sample preparation system in Europe. MGISP-Smart 8 is an eight-channel pipetting robot capable of independent multi-channel positioning and dual-level liquid detection, according to MGI. Equipped with technologies such as an intelligent integrated gripper and triple slide track design, the instrument enables a variety of applications, including sequencing library preparation to nucleic acid detection and sample preparation.

Bio-Rad Molecular Blood Screening Controls for HBV, HCV, and HIV-1

Bio-Rad Laboratories said this week that its Exact Diagnostics HBV, HCV, and HIV-1 Screen Controls are now available to laboratories in Europe after having received CE IVD marking earlier this year. These controls are designed to monitor the performance of blood donor screening assays, including extraction, amplification, and detection, and are calibrated against WHO International Standards for HBV, HCV, and HIV-1. The products are made of whole viruses in a high-quality citrate plasma matrix to ensure lot-to-lot reproducibility, have an 18-month shelf life from date of manufacture (when stored at -20° C or below), and have a 24-hour stability (when stored at 2-8° C).

Sentinel Diagnostics SentiNat 200 System, Stat-Nat SN200 Assays

Sentinel Diagnostics has launched the fully automated SentiNat 200 sample-to-result system and Stat-Nat SN200 real-time PCR assays to quantitatively detect 10 viruses. According to the Milan, Italy-based firm, the products are for midsized to large laboratories that diagnose viral infections. SentiNat 200 is a compact platform for DNA/RNA extraction, PCR setup, and amplification. It contains two integrated thermal cyclers and FastFinder analysis software and can be used to perform a multiparametric analysis of up to 15 viruses in one run, Sentinel said, adding the assay can process as many as 48 samples in four hours.

PCR Biosystems Clara qPCR Reagent Mixes

PCR Biosystems has launched three Clara qPCR reagent mixes: Clara Probe Mix, Clara Probe 1-Step Mix, and Clara HRM.

The Clara Probe Mix is a concentrated 4x mix for single and multiplex assays that enables detection of DNA targets down to 1 pg/ml of cDNA. The mix can be used for melt-curve analysis and is available in No-ROX, Lo-ROX, Hi-ROX, and separate-ROX options. The Clara Probe 1-Step Mix is a single tube 4x RT-qPCR mix for universal probe-based detection of RNA and DNA targets in single and multiplex assays. The Clara HRM Mix uses SyGreen 2 dye with a 2x qPCR mix and can be used to detect genetic mutations, identify genotypes based on SNPs, or calculate percent methylation of a target region. It is compatible with many standard qPCR thermocyclers.

For more new products and services, please visit the New Products page on our website.