BioNano Genomics Inc (NASDAQ: BNGO) stock price rose 50. 42% from a previous closing price of $ 0. 88 to $ 1. 33. And it’s up more than 133% since last week. The company’s announcements in recent weeks have set the momentum.
Bionano Genomics announced on 28. December announced that its client Praxis Genomics has been accredited by the College of American Pathologists (CAP). This makes Bionano Genomics the first CAP-accredited CLIA-certified diagnostic laboratory in the USA that offers a laboratory-developed test (LDT) based on total genome analysis with Saphyr. The LDT was developed for postnatal patients who are suspected of having a constitutional genetic disorder.
Praxis uses optical genome mapping (OGM) with the Saphyr system from Bionano as an alternative to conventional methods of chromosomal microarrays (CMA) and karyotyping (KT) to improve the clinical diagnosis rate in patients with genetic diseases. And CMA and KT together typically diagnose 30-50% of the patients tested. Recent studies have shown that OGM with Saphyr is consistent with CMA and KT and also diagnosed a significant proportion (18-25%) of patients who could not be diagnosed using traditional methods.
Medical guidelines have recommended sequential rounds of analysis with CMA, KT, repeated expansion tests, single gene or gene panel tests, and sequencing of the entire exome until a pathogenic variant is identified or until the various techniques are exhausted. In practice, this tiered approach is replaced upon request with an analysis of the whole genome using OGM with sapphyr for structural variants (SVs) and an analysis of the whole genome by next generation sequencing (NGS) for individual nucleotide variants (SNVs).
This workflow eliminates costly and time-consuming steps such as cell culture and tedious manual data analysis across multiple platforms, and provides a streamlined approach to detecting all types of genomic aberrations to achieve a higher rate of diagnosis faster, easier and faster, lower economic costs for laboratories and Counter.
Several diagnostic laboratories in the U. . S.. . Like PerkinElmer Genomics and the University of Iowa hospitals and clinics, they have already introduced sapphire-based LDTs that target a specific clinical indication, a form of muscular dystrophy called FSHD1. Whilst in Europe full genome clinical tests with sapphyr have been developed for various clinical applications, including hereditary genetic disorders and leukemias, the clinical practice service is the first to offer full genome analysis in the United States. S.. .
On 23. December, Oppenheim-based analyst Kevin DeGeeter confirmed an outperform (buy) rating for BNGO shares. And he assigned the company a price target of $ 1. 50.
Bionano Genomics announced the publication of a study by the Human Genome Structural Variation Consortium (HGSVC) which found that their sequencing method based on PacBio HiFi-Reads only detects 72% of the large SVs that Bionanos Optical Genome Mapping (OGM) detected different human genomes in 32 cases. The consortium developed its custom sequencing method by combining sequencing with PacBio and the StrandSeq single-strand prep and sequencing method to create a comprehensive catalog of human SVs with base pair and haplotype resolution.
The cost of the method is calculated based on the list prices on 10. 000 to 20. Estimated $ 000 per genome. And OGM with sapphire – which costs less than $ 500 per genome – was found to be significantly more sensitive than the sequencing method. And many of the SVs that have been overlooked by sequencing technologies overlapped with complex regions of the genome that cause microdeletion and microduplication syndromes – which are of high clinical relevance because of their involvement in neurodevelopmental disorders.
Analysis mainly focuses on insertions and deletions that are easier to see for sequencing. Other studies have shown that OGM significantly outperforms sequencing to detect other SVs such as inversions and translocations – which are also of high clinical relevance, especially in cancer. In the publication, some large SVs were identified as unambiguously by the PacBio HiFi-based sequence-based method. Upon further analysis, most of these SVs were indeed identified by OGM, but classified differently. Overall, less than 2% of the large SVs detected by PacBio were missed by OGM.
Bionano Genomics recently announced that an important milestone for the throughput of its Saphyr system has been reached. With the release of a software update this week for the Saphyr instrument, which is part of its optical genome mapping system, the system can now track up to 96 human genomes per week up to a coverage depth of 100x (or 4. 992 samples per year) under the assumption of continuous operation.
Since Saphyr was introduced in 2017, the annual throughput of 384 samples per year has decreased by 1. 400% to almost 5. 000 samples per year increased. The expansion in throughput has been driven by the increased use of the Saphyr system in a variety of high volume environments, including discovery research and cytogenomics.
Starting today, the software update will be pre-installed on all delivered or installed systems and is available free of charge for immediate installation on all Saphyr systems installed on site, including the first-generation Saphyr systems delivered before 2019 of 15% see.
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Bionano Genomics, Stock, NASDAQ: BNGO, NASDAQ, Genomics
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