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Bionano Genomics, Inc. (Nasdaq: BNGO) is a pioneering company in the life sciences instrumentation sector, dedicated to advancing genome biology understanding through innovative solutions. The company is renowned for its development and marketing of the Saphyr™ system, an ultra-sensitive platform designed for structural variation detection. This system enables researchers and clinicians to accelerate diagnostics and therapeutic target discovery, streamlining studies on chromosomal changes.
Bionano's core mission is to transform genomic analysis through optical genome mapping (OGM) solutions, diagnostic services, and software. Their flagship product, Saphyr™, offers unmatched capabilities in structural variation discovery and the ability to construct comprehensive genome assemblies. This technology is crucial for applications in cancer research, human disease studies, agricultural bioengineering, and genome discovery.
Recent achievements include the detection of unique structural variations and gene fusions in blood cancer samples, underscoring OGM's potential as a complement to traditional sequencing methods. Bionano's OGM technology has shown superior sensitivity and resolution in various studies, highlighting its utility in pediatric leukemia and other cancers.
The company operates globally with significant revenue from the Americas, and it generates product revenue from the sales of OGM and Ionic Purification systems and consumables. Bionano also offers diagnostic testing for neurodevelopmental disabilities through its Lineagen, Inc. d/b/a Bionano Laboratories business and industry-leading genome analysis software that integrates next-generation sequencing and microarray data.
Partnerships with AI-driven companies like Diagens further enhance Bionano's offerings, aiming to improve reproductive health and other clinical applications. Additionally, Bionano continuously upgrades its VIA software and Bionano Solve pipeline to provide researchers with precise and sensitive genomic research tools.
For more information, visit Bionano Genomics and its associated websites, www.bionanolaboratories.com and www.purigenbio.com.
Bionano Genomics (Nasdaq: BNGO) announced plans for an underwritten public offering of its common stock, with Oppenheimer & Co. Inc. as the sole book-running manager. All shares offered will be sold by Bionano, and underwriters may purchase an additional 15% to cover over-allotments. This offering is under a previously filed "shelf" registration statement, which is effective until August 2023. The company has emphasized potential risks associated with market conditions and closing conditions of the offering, which may affect completion. Further details will be available in the filed prospectus.
Bionano Genomics (Nasdaq: BNGO) announced the publication of a genome analysis of Professor Temple Grandin, highlighting the significance of genetic testing for Autism Spectrum Disorder (ASD). Conducted by Lineagen, Bionano's CLIA-certified diagnostic subsidiary, the study identified novel variants in ASD risk genes, improving clinical management of Grandin's symptoms. Dr. Grandin emphasized the life-changing potential of genetic testing, while CEO Erik Holmlin noted that only 3% of ASD-diagnosed children receive clinical genetic testing, advocating for widespread adoption to inform treatment decisions.
Bionano Genomics (Nasdaq: BNGO) has received a 180-day extension from Nasdaq to comply with the $1.00 minimum bid price requirement, now until June 28, 2021. This decision follows the company's adherence to other continued listing requirements. Nasdaq's notification allows the company to maintain its stock listing while it works towards regaining compliance. Bionano plans to consider a reverse stock split if necessary to achieve this goal. CEO Erik Holmlin expressed optimism about the company's progress and ongoing efforts to advance the Saphyr System in target markets.
Bionano Genomics has announced that Praxis Genomics received CAP accreditation, becoming the first U.S. lab offering a laboratory developed test based on whole genome analysis using the Saphyr system. This test targets postnatal patients with suspected genetic disorders and significantly increases the diagnosis rate compared to traditional methods.
With 18-25% additional diagnoses achievable through Saphyr, the streamlined approach promises a faster and more cost-effective solution for detecting genomic variations. The CEO acknowledged this step as crucial for future reimbursement opportunities.
Bionano Genomics (Nasdaq: BNGO) announced a study showing its optical genome mapping (OGM) detected 72% more large structural variants (SVs) compared to PacBio's sequencing method across 32 human genomes. The OGM technology costs less than $500 per genome, while PacBio's method is estimated at $10,000 to $20,000. The study highlights the clinical relevance of OGM for detecting SVs linked to neurodevelopmental disorders and cancer. Bionano's Saphyr system can produce clinical quality SV calls efficiently, demonstrating superior performance in structural variation detection.
Bionano Genomics (BNGO) announced a significant milestone for its Saphyr System with a new software update increasing annual throughput by 1,400% from 384 to nearly 5,000 human genomes. The update allows for imaging up to 96 genomes weekly at a 100x coverage depth. New features include Saphyr Assure, an automated health monitoring tool for data quality. This advancement supports high-volume settings like discovery research and cytogenomics, and comes pre-installed on new systems while being available to existing users free of charge.
Bionano Genomics (Nasdaq: BNGO) announced a pivotal publication in the Proceedings of the National Academy of Sciences, detailing how the Saphyr system effectively characterizes the integration of human herpesvirus 6 (HHV-6) within the human genome. This international collaboration demonstrated that traditional molecular techniques failed to pinpoint the viral integration sites, highlighting Saphyr's unique capabilities in imaging long DNA sequences. CEO Erik Holmlin emphasized the significance of this research in understanding HHV-6's impact on human health, as its integration can lead to various diseases.
Bionano Genomics (BNGO) is showcasing its Saphyr System as a diagnostic tool for hematologic malignancies at the ASH Annual Meeting. Dr. Rashmi Kanagal-Shamanna from MD Anderson will present on Saphyr's performance in Myelodysplastic Syndrome (MDS). Additionally, Dr. Barbara Dewaele will discuss a validation study for Acute Lymphoblastic Leukemia (ALL). The conference takes place from December 5-8, focusing on advancements in genomic diagnostics.
Bionano Genomics announced that its Saphyr system for optical genome mapping is being highlighted at the Annual Meeting of the Association for Molecular Pathology (AMP) from November 16-20, 2020. The event focuses on advancements in molecular diagnostics, with Bionano showcasing its technology in various presentations, including a corporate workshop. The application of the Saphyr system spans multiple clinical applications, especially in complex genetic disorders and heme malignancies, marking a significant step in molecular pathology education.
Bionano Genomics (NASDAQ: BNGO) reported Q3 2020 financial results, with total revenue of $2.2 million, an 86% sequential increase but down 33.7% year-over-year. The decrease is attributed to a change in revenue mix. Operating expenses rose to $11 million, driven by acquisition-related costs and increased workforce. Bionano completed the acquisition of Lineagen and received accolades for Saphyr as a first-line tool for leukemia diagnostics. Cash and equivalents stood at $18.9 million, up from $17.3 million at year-end 2019. A conference call to discuss the results is scheduled for November 12.
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