Bionano Genomics, Inc. - BNGO STOCK NEWS

Bionano Genomics (BNGO) announced three peer-reviewed publications validating optical genome mapping (OGM) as a superior alternative to traditional cytogenetic methods for analyzing hematological malignancies. The studies indicate that OGM demonstrates high concordance rates with traditional methods, revealing additional relevant genetic variants that could influence clinical decisions. Key findings include:

• 91% concordance in acute myeloid leukemia (AML) and 83% in myelodysplastic syndrome (MDS).
• OGM's detection threshold can be lowered to 1-2% variant allele fraction.
• OGM provides results in 4 days without cell culture.

The research highlights OGM's potential for enhanced patient management and risk assessment, positioning it as a first-tier cytogenetic testing option.

Bionano Genomics (Nasdaq: BNGO) announced preliminary financial results for Q1 2023, predicting total revenues between $7.3 million and $7.5 million, reflecting a 28% to 32% increase from Q1 2022. The installed base of Saphyr® systems grew to 259, marking a 47% year-over-year rise, with an increase of 19 systems in the quarter. Additionally, 5,226 nanochannel array flowcells are expected to be sold, indicating a 62% growth over the previous year. Bionano has decided to withdraw its applications for Category I CPT codes for optical genome mapping (OGM) to avoid potential assignment of less favorable Category III codes. This quarter marks the 10th consecutive quarter of revenue growth, with a revenue guidance of $35 million to $38 million for the full year 2023.

Bionano Genomics (Nasdaq: BNGO) announced its participation in the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place from April 14-18, 2023, in Orlando, Florida. The company will showcase the utility of optical genome mapping (OGM) in cancer research through various presentations and scientific posters. Notably, experts, including Dr. Ben Finlay, Dr. Marc Henri Stern, and Dr. Rashmi Kanagal-Shamanna, will present on the applications of OGM in analyzing tumor biopsies, identifying biomarkers, and exploring treatment approaches for leukemia. The conference will facilitate discussions among industry and academic professionals on advances in cancer science.

Bionano Genomics announced a significant study publication from Radboud University Medical Center that showcases the effectiveness of optical genome mapping (OGM) in identifying gene-disruptive structural variants (SVs) associated with inherited retinal diseases (IRDs). This research revealed a large inversion impacting the USH2A gene, previously disregarded by next-generation sequencing (NGS) as a false positive. The study found that OGM could improve SV detection and identified 30 likely pathogenic SVs in 427 IRD cases. 8 of these variants were previously overlooked. Bionano's CEO, Erik Holmlin, highlighted the importance of OGM in genetic research, particularly in complex disorders, emphasizing its ability to enhance diagnosis and treatment prospects.

Bionano Genomics announced a groundbreaking study using optical genome mapping (OGM) to identify structural variants (SVs) related to Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome, affecting 1 in 4,500 females. The study analyzed samples from 87 MRKH patients and 47 parents, confirming the presence of 14 rare SVs in 19.5% of probands, and additional SVs in 27.6%. OGM demonstrated higher resolution and sensitivity than traditional methods, with significant findings including the first report of a MRKH patient with mosaicism for trisomy 12. This research may enhance understanding and treatment options for MRKH, a syndrome impacting female reproductive health.

Bionano Laboratories expanded its clinical testing menu by launching two new laboratory developed tests (LDTs) based on optical genome mapping (OGM): OGM-Dx^TM Postnatal Whole Genome SV and OGM-Dx^TM Prenatal Whole Genome SV. The Postnatal test assesses structural variants in individuals with conditions like autism spectrum disorder and epilepsy, while the Prenatal test is for fetuses suspected of genetic anomalies. Both tests aim to provide comprehensive genome-wide assessments, assisting clinicians in patient management. The company emphasizes that these tests may facilitate OGM adoption in clinical and research settings.

Bionano Genomics (BNGO) announced its involvement in the ACMG Annual Meeting 2023, showcasing the significance of optical genome mapping (OGM) in genetics. CEO Dr. Erik Holmlin will present at the awards ceremony on March 15, alongside Dr. Bruce Korf, to honor LGG award recipients. The conference will feature key sessions on OGM's utility in detecting structural variants and its application in prenatal and postnatal analysis. Notable research presentations will include comparisons of OGM to traditional methods. The event highlights Bionano's commitment to advancing genetic disease research and supporting future leaders in the genomics field.

Bionano Genomics reported Q4 2022 revenue of $8.2 million, a 30% increase from Q4 2021. The total revenue for 2022 reached $27.8 million, marking a 55% increase over 2021. The company installed 240 Saphyr® systems by year-end, a 46% rise from 2021. Key validations showing optical genome mapping's (OGM) effectiveness for prenatal and postnatal genetic disorders were published. Full-year 2023 revenue is forecasted between $35 million and $38 million, indicating growth of 26% to 37% from 2022. However, operating expenses surged, with Q4 2022 GAAP operating expenses at $39.3 million.

Bionano Genomics (BNGO) announced two publication results from its clinical trial evaluating optical genome mapping (OGM) for diagnosing genetic disorders in postnatal patients. The peer-reviewed study revealed a 99.5% concordance rate of OGM against standard care methods and a 90.2% first-pass success rate. A subsequent preprint further confirmed a 99.6% overall concordance with 560 additional samples. Notably, OGM showed a 42% increase in reportable findings for genetic disorders and a 32% increase for autism spectrum disorders. The findings position OGM as a potential standard in genetic diagnosis, offering improved efficiency and accuracy.