Bionano Genomics announces publication on use of OGM to identify SVs » 08:0301/2001/20/22
Bionano Genomics announced the publication of a study that described the use of OGM to identify rare human genomic structural variants (SVs) as predisposition factors associated with severe COVID-19, highlighting the potential role of SVs in the pathogenesis of COVID-19 severity. The International COVID-19 Host Genome Structural Variation Consortium is a global open host genome structural variation consortium for the COVID-19 response. It is comprised of over 30 researchers from leading institutions who are using long-read molecule technologies, including OGM, to assess SVs in the human genome that could be contributing to COVID-19 susceptibility or progression. In this peer-reviewed study, published in the journal iScience, researchers performed OGM on samples from 52 severely ill COVID-19 patients to investigate SVs as decisive predisposition factors associated with COVID-19. They identified 7 SVs in 9 patients involving genes implicated in two key host-viral interaction pathways: innate immunity and inflammatory response, and viral replication and spread. The study authors reported that SVs in two genes, STK26 and DPP4, are the most intriguing candidates in these biological pathways. As the authors indicate, this is the first study to systematically assess the potential role of SVs in the pathogenesis of COVID-19 severity. These findings indicate that SVs can be a factor in COVID-19 severity and expand the research community's understanding of COVID-19 susceptibility and progression.
Bionano Genomics announces average daily attendance of 565 for 2022 Symposium » 08:0401/1901/19/22
Bionano Genomics announced the conclusion of Bionano's 2022 Symposium, with record daily attendance representing a 63% increase relative to last year's event. Bionano's premier scientific event showcasing OGM, Symposium was held January 10-13, 2022. Symposium had over 4,000 registrants from 82 countries and featured 31 oral presentations and 37 scientific posters from genomic scientists at leading institutions, including Brigham and Women's Hospital, MD Anderson Cancer Center, and Quest Diagnostics. During this four-day online event, presenters reported on their use of OGM and its utility for genetic disease and cancer applications.
|Over a week ago|
Wall Street in Fives - Must Read Lists for Wednesday » 16:3101/1201/12/22
BIIB, C, FLMN, JOBS, MRNA, PYPL, SNOW, DASH, BZFD, SHOP, SAN, DIDI, AAPL, TSLA, T, DISH, OCGN, PL, BBBY, HYZN, JEF, WIT, DGX, PHG, ISRG, BNGO, KLR
Get caught up quickly on…
Wall Street in Fives - Must Read Lists at Midday » 12:1401/1201/12/22
BIIB, C, FLMN, JOBS, T, DISH, SAN, DIDI, AAPL, PRDS, TSLA, OCGN, PL, BBBY, HYZN, JEF, WIT, DGX, PHG, ISRG, BNGO, KLR, PYPL, SNOW, DASH, BZFD, SHOP
Get caught up quickly on…
Bionano Genomics sees 2021 revenue $17.5M-$17.9M, consensus $17.13M » 08:1401/1201/12/22
"We ended the year…
"We ended the year with a lot of momentum across the business and have achieved or exceeded all of the milestones we set out at the beginning of 2021," commented Erik Holmlin, PhD, President and CEO of Bionano. "The integration of BioDiscovery is going well and the results from our first interim readout from our postnatal clinical trial exceeded our expectations. Additionally, there is a lot of excitement around our 2022 Symposium, which began earlier this week."
Bionano Genomics sees Q4 revenue $5.8M-$6.2M, consensus $5.44M » 08:1301/1201/12/22
Bionano also reported a…
Bionano also reported a record net increase in the installed base of 23 Saphyr systems in the fourth quarter of 2021, bringing the year-end total to 164, representing a 69% increase over the 97 installed systems reported at the end of 2020 and exceeding our goal of 150 systems by the end of 2021.
Bionano Genomics announces publication of interim readout from trial on OGM » 08:5801/1001/10/22
Bionano Genomics announced the publication of the first readout from the ongoing clinical trial designed to support establishing optical genome mapping, OGM, as part of standard of care, SOC, in diagnosis of genetic disease for postnatal patients. This publication reports on the postnatal genetic disease diagnostic arm of Bionano's study to evaluate OGM as an alternative to SOC workflows in four key clinical areas: prenatal and postnatal genetic diseases, hematologic malignancies and solid tumors. Study Design: The study is an Institutional Review Board-approved, multicenter, double-blinded trial with 202 clinical research subjects analyzed in a total of 331 sample runs. All samples had been previously tested with traditional methods like karyotyping, fluorescence in situ hybridization and chromosomal microarray. The samples were from cases with a genetic diagnosis, cases without a genetic diagnosis and controls. Key Findings: This publication describes OGM performance metrics like first pass success rate and reproducibility from site-to-site, operator-to-operator and run-to-run for the first time ever and for the largest number of samples investigated with OGM to date. Key findings for the technical endpoints were reported as follows: Concordance with SOC - 97.7%; Partially concordant with SOC - 2.3%; Concordance with SOC for pathogenic variant calls - 100%; Concordance with CMA - 100%; First-pass success rate for OGM - 94%; Reproducibility of analytical QC from site-to-site - 98.8%; and Reproducibility of pathogenic variant calls from site-to-site - 100%. Key Takeaways: The authors concluded that a single approach, like OGM, can allow genetic laboratories to provide rapid results with a cost-effective solution, which can benefit both the lab and the affected individuals.
Bionano Genomics announces prototype for next single molecule imaging system » 08:0612/2912/29/21
Bionano Genomics announced that it has completed the first prototype for its next single molecule imaging system for OGM. The prototype is being used to integrate and test the key engineering designs of a new instrument and consumable intended to meet the needs of high volume users. The commercial system based on this prototype is expected to be released in the first half of 2023. The company said, "We believe OGM provides the most comprehensive, reliable and cost-effective solution for detecting structural variations. OGM is a workflow comprised of four proprietary stages: ultra-high molecular weight DNA isolation; sequence-specific DNA labeling; single molecule linearization & imaging; and data processing and analysis. The third stage creates the molecule images and sequence motif patterns that are used to reveal SVs. This stage also sets the limit on the number of samples that can be processed per day. The throughput of the current Saphyr system is designed for the volumes encountered by academic medical centers doing standard clinical research in genomics, but large reference laboratories and contract research organizations with higher volumes require an instrument with higher throughput capabilities. Compared to the Saphyr system, which images DNA at a rate of approximately 205 Gbp per hour, the new system is expected to image nearly 820 Gbp per hour. The new instrument is designed to be configurable into an array of up to four instruments processing samples in parallel approximately six months after initial release. Other anticipated features of the new system include a new consumable design, higher capacity carousel for staging samples to be imaged and updated optical components all in a space-efficient benchtop footprint. The new imaging system will also incorporate features designed to make high throughput workflows more flexible, allowing for data collection to start without needing to wait for multiple samples being available, enabling high-coverage cancer experiments to be run next to lower coverage constitutional experiments and the ability to prioritize samples to be run ahead of all others. This flexibility is expected to surpass that of peer sequencing systems, where getting this flexibility often means waiting for enough samples to fill a flow cell or paying a significant per sample premium to have a sample consume more of a consumable. Prototype photos of the next single molecule imaging system for OGM will be made available on Bionano's social media channels on December 31, 2021."
Oppenheimer bullish on Bionano Genomics, sees potential Q4 upside » 08:0612/2712/27/21
Oppenheimer analyst Kevin…
Oppenheimer analyst Kevin DeGeeter notes that Bionano Genomics is on track to meet or exceed its 2021 Saphyr placement goal of 150-plus. Multiple clinical validation studies to support reimbursement are enrolling well and commercial adoption is leading to higher consumable pull-through that should impact Q4 and 2022, he adds. On the last point, DeGeeter spoke to management regarding disclosure late last week regarding accreditation of University Hospitals Leuven in Belgium, which should drive uptick in consumables beginning in Q4. Bionano noted Leuven is one of several European labs completing accreditation with each high-volume lab expected to process 300-500 samples annually at $400-$500 per sample. The analyst has an Outperform rating and a price target of $14 on the shares.
|Over a month ago|
Bionano says University Hospitals Leuven expand BELAC-accredited menu » 08:0812/2312/23/21
Bionano Genomics announced that University Hospitals Leuven in Belgium, after previously receiving its accreditation from the Belgian Accreditation Body for using OGM in analysis of acute lymphoblastic leukemia, is expanding its BELAC-accredited menu to include acute myeloid leukemia, chronic lymphocytic leukemia and facioscapulohumeral muscular dystrophy. "With the flexibility we now have as an accredited laboratory by BELAC, our teams can develop OGM-based assays addressing hematological malignancies without the need for a new audit," said Barbara Dewaele, PhD, supervisor of the Laboratory for Genetics of Malignant Disorders at University Hospitals Leuven. "We are excited to move forward using this valuable tool to analyze the genomes of patients with cancer and rare diseases." At the European Cytogenomics Conference in July 2021, Dr. Dewaele shared the results of implementing an OGM-based assay for ALL patients that her team developed with Bionano's Saphyr system. As presented by Dr. Dewaele and her team, compared to their existing workflow, the new workflow including OGM as a primary analysis method reduced the number of fluorescence in-situ hybridization probes used by 90% and eliminated the need for multiplexed ligation polymorphism assays. In their new workflow including OGM, it is complemented with karyotyping to detect ploidy changes and the presence of small subclones. This transformation resulted in a turnaround time that was 14 days faster, a cost savings of approximately 50% and higher overall success rates in finding pathogenic variants in samples. In parallel, as part of their menu expansion efforts, and under the direction of Dr. Valerie Race, Center for Human Genetics at University Hospitals Leuven, a validation of Bionano's EnFocus FSHD tool will be conducted on a prospective cohort of FSHD samples to confirm OGM's capability to accurately measure the length of D4Z4 repeat arrays and assess reproducibility and repeatability of the workflow. Preliminary results were presented at the European Society of Human Genetics conference in August 2021, and reported that OGM can be a powerful and robust technique for FSHD testing in genetic diagnostic laboratories by providing results that are concordant with the current gold standard, Southern blot analysis in a substantially simpler workflow that does not use radioactivity. Dr. Dewaele reported that she and her colleagues have doubled their weekly sample volume relative to when they first started using their Saphyr system and believe they are on track to reach their goal of 500 samples per year with this instrument. The teams at University Hospitals Leuven believe that the time and cost savings from using OGM-based assays could be a competitive advantage relative to traditional techniques. OGM is also complementary to many of the tools used in typical molecular pathology and cytogenomics labs and, as a result, it can be helpful to interpretation of results from assays such as karyotyping, which can be used to confirm OGM findings.