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Contextual Genomics 'Find It' and 'Follow It' Assays

Dec 21, 2018

Contextual Genomics, a Vancouver, Canada-based cancer genomics company, said that it has completed development of two new products: an improved version of its Find It hotspot panel for detection of genomic mutations in solid tumour cancers; and its Follow It hotspot panel for detection of the same genomic mutations in blood plasma.

The Find It panel now screens for 146 somatic genome alterations found in solid tumor cancers to identify optimal therapeutic treatments and recognize acquired drug resistance mutations. The assay is supported by Contextual's cloud-based genome analysis engine (CGIRP).

The Follow It panel screens for cell-free circulating tumour DNA in plasma, and is designed to  be used in patients with widespread metastatic disease at diagnosis and as a time series monitoring tool to read out tumor burden and treatment resistance. Follow It will screen for all of the same somatic genome alterations as Find It and can be used to follow disease progression for patients, including those whose tumors were initially tested with Find It.

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Dec 03, 2020

Meridian Bioscience Air-Dryable RT-qPCR Mix

Meridian has launched its Air-Dryable RT-qPCR mix, a specialized master mix designed for air drying instead of lyophilization. The ready-to-use mix has ambient temperature stability and removes the need for cold chain shipping and storage, the company said. Its one-tube format chemistry contains all the reagents necessary for RT-qPCR, including magnesium, dNTP, and reverse transcriptase.

The mix is designed to simplify development, manufacturing, and storage of molecular tests, along with delivering fast detection of RNA targets, making the mix ideal for COVID-19 testing, the firm said. Meridian added that the mix has high performance in singleplex and multiplex reactions after rehydration.

Nov 17, 2020

GeneMatters Automation for Pioneer Telegenetics Platform and RISE Patient Engagement Tools

GeneMatters has added automation features to its Pioneer Telegenetics Platform and has launched RISE Patient Engagement Tools to support patients undergoing genetic testing and counseling.

The Pioneer Telegenetics Platform, available since 2017, is designed to integrate telehealth genetic counseling service delivery and patient management. The platform now includes several automation features designed to reduce administrative burden, provide real-time communication, and allow GeneMatters to quickly deploy custom workflows to meet partner needs.

The RISE (Reach, Inform, Support, and Educate) Patient Engagement Tools specifically support patients and can be used independently or as a complement to Pioneer, and will include modules for genetic care such as scheduling, patient triage, patient education, and results delivery.

Nov 11, 2020

NeoGenomics Mobile Phlebotomy Services

NeoGenomics has launched a mobile phlebotomy service for its blood-based tests, including the InVisionFirst-Lung assay and the NeoLab liquid biopsy suite of tests. The firm will offer in-home mobile phlebotomy services through ExamOne and Metro Health Staffing. NeoGenomics said it will arrange for the blood sample collection at the patient's desired location and cover the expense of the service. 

Nov 10, 2020

Galaxy Diagnostics Nanotrap Urine Test for Lyme Borreliosis

Galaxy Diagnostics has launched the Nanotrap Urine Test for Lyme Borreliosis. According to the Research Triangle Park, North Carolina-based firm, the antigen test provides the most sensitive direct detection of Borrelia burgdorferi at all stages of the disease. It leverages Nanotrap technology developed by Ceres Nanosciences to capture and concentrate low abundance outer surface protein A in urine samples confirmed by Western blot.

Nov 10, 2020

NIPD Genetics: Amfira PGT

NIPD Genetics has launched Amfira PGT, a preimplantation genetic test to detect genetic abnormalities in embryos. The test consists of two panels, the PGT-A panel for aneuploidies for individuals or couples undergoing in vitro fertilization, and the PGT-SR panel for structural rearrangements for couples diagnosed with a structural rearrangement. Both panels can detect selected male polyploidies, as well as deletions and duplications larger than 10 megabases. The turnaround time is five to seven days from sample receipt.

Nov 06, 2020

Bio-Rad: StarBright Dyes

Bio-Rad has launched three new dyes for flow cytometry in its StarBright line. StarBright Blue 700, StarBright Violet 440, and StarBright Violet 610 consist of fluorescent nanoparticles conjugated to flow antibodies. The dyes offer narrow excitation and emission profiles for improved resolution in flow cytometry experiments. They are also resistant to photobleaching and highly stable, with minimal lot-to-lot variation, according to Bio-Rad, which enables researchers to achieve consistent and reproducible staining. The dyes work with all common staining buffers for easy integration into multicolor panels and the chemistry is designed to ensure no loss of signal in fixation.

Nov 05, 2020

Enzo Biochem Microplate Reader

Enzo Biochem launched a small portable microplate reader for use with the company's immunoassays and molecular diagnostics. Enzo provides more than 17,000 ELISA assays and kits. The design and technology of the new compact microplate reader makes it possible to deliver precise and accurate results, the firm said.

The Enzo portable reader enables lab work to be executed outside of traditional research facilities, giving researchers and lab professionals a dedicated, personal device to fit their space and needs with convenience and accessibility. The handheld instrument is about one-tenth the size of the average benchtop plate reader, allowing it to fit into any laboratory setting and saving bench space, while providing flexibility and portability that can be extended to point-of-care facilities to allow physicians to provide molecular testing.

In the future, the company said it anticipates launching isothermal testing on this platform, enabling constant temperature and eliminating the need for a thermal cycler.

Nov 02, 2020

Castle Biosciences DecisionDx DiffDx-Melanoma

Castle Biosciences has launched DecisionDx DiffDx-Melanoma, a gene expression profile test for use in patients with suspicious pigmented lesions. The test is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions, and classifies these lesions as either benign (gene expression profile suggestive of benign neoplasm), intermediate-risk (gene expression profile cannot exclude malignancy), or malignant (gene expression profile suggestive of melanoma).

The intent-to-treat analysis of the DiffDx-Melanoma validation study showed that the test accurately diagnosed malignant and benign cases at a rate of 96.6 percent, with 99.1 percent sensitivity, 94.3 percent specificity, 93.6 percent positive predictive value, and 99.2 percent negative predictive value, the company said. An intermediate-risk result was identified in 3.6 percent of the cases.

Oct 27, 2020

Enzo Biochem GoTestMeNow

Enzo Biochem has launched GoTestMeNow, an online platform that enables consumers to directly order physician-authorized laboratory tests. GoTestMeNow can be used to access necessary medical tests without the need for a doctor's office visit, the company said. Specimen collection and testing is accomplished through a network of patient service centers in the New York/New Jersey metro area and consumers can get their results through a secure online portal. The platform will also facilitate any issues related to payment, including insurance coverage.

The GoTestMeNow platform will initially support access to COVID-19 molecular and antibody testing, and will then be expanded to offer access to a broad range of additional tests in the near future, Enzo added.

Oct 23, 2020

Fabric Genomics Fabric GEM Algorithm for Genetic Disease Diagnosis

Fabric Genomics has launched Fabric GEM, an algorithm designed to identify the likely genetic cause of rare diseases from next-generation sequencing data. Fabric GEM, the latest product in the Fabric Enterprise software suite, uses artificial intelligence to analyze sequencing data (including complex structural variants) and patient clinical information in order to perform probabilistic disease matching and speed genetic diagnoses. The algorithm was developed in collaboration with Mark Yandell of the University of Utah and Stephen Kingsmore of Rady Children's Institute for Genomic Medicine, Fabric said.

Oct 22, 2020

Bionano Genomics Access v1.6, Solve v3.6

Bionano Genomics has updated its suite of data analysis and visualization software tools for its Saphyr genome mapping platform. The new version of Bionano Access is designed to simplify and accelerate every step in the data-analysis workflow, enabling clinical labs to develop tests on the Saphyr more easily. It builds on the Bionano EnFocus FSHD Analysis tools for the automated analysis of variants in a form of muscular dystrophy to allow for similar automated variant analysis for EnFocus panels for other genetic conditions. These include autism spectrum disorder, developmental delay, and repeat expansion disorders, as well as hematologic malignancies and solid tumors. The new version also enables Bionano EnFocus FSHD data to be analyzed on a PC rather than in the cloud or on a compute cluster. In addition, it reduces the time and increases capacity for analyses run on Bionano's cloud-based platform.

Oct 20, 2020

Genome Diagnostics NGSgo-MX11-3 Multiplexing for HLA Typing

Genome Diagnostics has launched NGSgo-MX11-3, its latest addition to a series of singleplex and multiplex amplification strategies for HLA typing by NGS. NGSgo-MX11-3 consists of amplification primers for eleven HLA genes — HLA-A, -B, -C, -DRB1, -DQB1 and -DPB1, DRB3/4/5, DQA1, and DPA-1 — in three mixes per sample. The three-tube design results in low noise levels and well-balanced alleles, making the data quality of the 11-loci multiplex similar to a singleplex strategy, Genome Diagnostics said. NGSgo-MX11-3 is available on a research-use-only basis. The firm anticipates that it will become available as a CE-marked IVD.

Oct 15, 2020

Magnolia Medical Steripath Micro Initial Specimen Diversion Device

Magnolia Medical Technologies launched its new Steripath Micro Initial Specimen Diversion Device, an FDA-cleared product indicated to reduce blood culture contamination. The device uses syringe-driven negative pressure to divert and sequester the first .6 to .9 mL of blood. The user then presses a button to isolate the diverted blood and a second blood flow pathway is opened to collect the blood specimen for culture in the syringe.

Oct 14, 2020

Paragon Genomics CleanPlex ARS-CoV-2-Related NGS Assays

Paragon Genomics has launched four new coronavirus-related CleanPlex next generation sequencing (NGS) assays. The new panels widen the capabilities of the firm's CleanPlex SARS-CoV-2 Research and Surveillance Panel, which allows researchers to sequence the SARS-CoV-2 genome and obtain accurate nucleic acid-level information on the virus for strain typing, mutation monitoring, and other epidemiological studies.

Paragon's CleanPlex ACE2 & TMPRSS2 Panel identifies genetic mutations in patients that are related to disease susceptibility and severity. The test targets genes affecting the binding affinity and expression of angiotensin-converting enzyme 2 (ACE2) and transmembrane serine rotease 2 (TMPRSS2). The panel interrogates the entire coding region of ACE2 and TMPRSS2, along with more than 70 curated unique quantitative trait loci that regulate their expression. Paragon noted the panel uses CleanPlex technology's three-hour workflow to produce enriched NGS libraries for all major sequencing platforms.

Paragon's CleanPlex SARS-CoV-2 FLEX Research Panel anticipates increases in SARS-CoV-2 viral mutations and offers extra assurance that mutation detection and genome coverage remain optimal. The FLEX panel specifically focuses on variant analysis and tracking of mutations over time. The test also includes degenerate primers and human RNA primer controls for more confident negative sample calling, especially when viral copies are not present or are at extremely low counts, the firm said.

The company also launched its plated 384 Unique Dual-Indexed PCR Primers for Illumina sequencing of its CleanPlex SARS-CoV-2 NGS panels. The primers will allow additional multiplexing capability so that researchers can simultaneously run up to 3,072 CleanPlex sequencing samples on Illumina NovaSeq instruments.

In anticipation of the upcoming flu season, Paragon is also releasing an early-access edition of the CleanPlex Respiratory Research Panel, which combines assays for SARS-CoV-2, influenza A subtypes H1N1, H1N2, H3N2, and influenza B. The combination panel allows for simultaneous influenza detection with SARS-CoV-2 detection or whole-genome sequencing. The extra sensitivity and additional coverage of the multiplex PCR-based method also works for high-throughput sample pooling and screening strategies, the firm said. Paragon expects to expand the panel to include respiratory syncytial virus and possibly other respiratory viruses in the future.

Oct 12, 2020

Exact Sciences Oncotype MAP Pan-Cancer Tissue Test

Exact Sciences has introduced the Oncotype MAP Pan-Cancer Tissue rapid, comprehensive tumor profiling panel test for patients with advanced, metastatic, refractory, or recurrent cancer. Oncotype MAP provides clinically actionable information from genomic alterations in hundreds of cancer-related genes, including tumor mutations, copy number variants, fusions, tumor mutation burden, microsatellite instability, and protein expression, allowing physicians to understand a patient's tumor profile and effectively recommend targeted therapies or clinical trials, the company said.

The test, which Exact acquired as part of its merger deal with Paradigm Diagnostics in February, was previously called PCDx. 

Oncotype MAP has a turnaround time of three to five business days to guide timely treatment decisions, a sample requirement of as little as 3 mm of tissue or 2-3 slides, and accurate and comprehensive results based on next generation sequencing and immunohistochemistry. Exact also noted that patients who used a previous generation of the test had a 43 percent rate of progression-free survival compared to 5 percent for patients who did not utilize the test.

The Oncotype MAP test report is based on NCCN Compendium-based recommendations, along with potential evidence-based therapies and clinical trials. The report is currently tailored to support clinical decision-making by showing actionable biomarkers associated with more than 100 evidence-based therapies, more than 45 combination therapies, and more than 650 active clinical trial associations, Exact added.