Bionano Laboratories Expands its Clinical Testing Menu with Launch of OGM-Based Laboratory Developed Tests (LDTs) for Prenatal and Postnatal Analysis

Rhea-AI Summary

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.

Positive

• Launch of two new laboratory developed tests (LDTs) for comprehensive genome assessment.
• Tests may aid in the diagnosis of conditions like autism spectrum disorder and genetic anomalies.
• Potential to enhance Optical Genome Mapping (OGM) adoption in clinical settings.

Negative

• Forward-looking statements include risks of tests failing to provide expected diagnostic benefits.
• Potential challenges in obtaining funding for OGM adoption and commercialization efforts.

SAN DIEGO, March 15, 2023 (GLOBE NEWSWIRE) -- Bionano Laboratories today announced the expansion of its clinical testing menu with the launch of 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. These LDTs offer a genome-wide assessment of structural variants (SVs) and provide comprehensive testing for most common and rare chromosomal abnormalities.

OGM-Dx^TM Postnatal Whole Genome SV tests peripheral blood samples from individuals who have diagnoses including but not limited to autism spectrum disorder (ASD), intellectual disability, developmental delay, epilepsy and rare undiagnosed genetic disease.  The OGM-Dx^TM Postnatal Whole Genome SV report will include a whole genome analysis of SVs and will screen for the common CGG expansion in the FMR1 gene that may indicate Fragile X syndrome.

OGM-Dx^TM Prenatal Whole Genome SV may be indicated for fetuses where a genetic anomaly is suspected, including abnormal ultrasound or positive non-invasive prenatal screening (NIPS), previous child with chromosomal abnormality and history of recurrent pregnancy loss. The reports from this LDT will include a whole genome analysis to assess for SVs of diagnostic and prognostic value.

“We are pleased to see the launch of Bionano Laboratories' LDTs for postnatal and prenatal analysis, which can assist patients in their diagnostic and prognostic journey. These LDTs are designed to provide a comprehensive evaluation of genome wide SVs that we believe will assist clinicians in assessing the best potential medical management for their patients,” stated Justin Leighton, vice president of laboratory business at Bionano Laboratories.

About Bionano Laboratories:

Bionano Laboratories provides access to genetic answers and support utilizing cutting-edge technologies to advance the way you see the genome.  Our clinical services offer a genetic testing experience that combines a comprehensive testing portfolio with thoughtful and accessible support options for the diagnostic journey. Bionano Laboratories also offers direct access to optical genome mapping for applications across basic, translational and clinical research. For more information, visit www.bionanolaboratories.com

About Bionano Genomics

Bionano Genomics is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through OGM solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also provides diagnostic testing for patients with clinical presentations consistent with autism spectrum disorder and other neurodevelopmental disabilities. Through its BioDiscovery business, the Company also offers an industry-leading, platform-agnostic software solution, which integrates next-generation sequencing and microarray data designed to provide analysis, visualization, interpretation and reporting of copy number variants, single-nucleotide variants and absence of heterozygosity across the genome in one consolidated view. For more information, visit www.bionanogenomics.com, www.bionanolaboratories.com or www.biodiscovery.com

Forward-Looking Statements of Bionano Genomics

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “can,” “potential,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the ability and utility of the OGM-Dx Postnatal Whole Genome SV test or OGM-Dx Prenatal Whole Genome SV test to detect SVs of diagnostic and prognostic utility; and the ability of OGM-based LDTs to remove barriers for OGM adoption in clinical and research settings. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of geopolitical and macroeconomic developments, such as the ongoing Ukraine-Russian conflict, and related sanctions, and the COVID-19 pandemic, on our business and the global economy; the failure of the OGM-Dx Postnatal Whole Genome SV test or OGM-Dx Prenatal Whole Genome SV test to detect SVs of diagnostic and prognostic utility i; the failure of OGM-based LDTs to remove barriers for OGM adoption in clinical and research settings; general market conditions; changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2022 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

CONTACTS
Company Contact:
Erik Holmlin, CEO
Bionano Genomics, Inc.
+1 (858) 888-7610
eholmlin@bionano.com

Investor Relations:
Amy Conrad
Juniper Point
+1 (858) 366-3243
amy@juniper-point.com

FAQ

What new tests did Bionano Laboratories launch on March 15, 2023?

Bionano Laboratories launched OGM-Dx^TM Postnatal Whole Genome SV and OGM-Dx^TM Prenatal Whole Genome SV tests.

What conditions can the OGM-Dx^TM Postnatal Whole Genome SV test help diagnose?

This test can help diagnose conditions such as autism spectrum disorder, intellectual disability, developmental delay, and epilepsy.

What is the purpose of the OGM-Dx^TM Prenatal Whole Genome SV test?

The Prenatal test is indicated for fetuses suspected of genetic anomalies due to factors like abnormal ultrasounds or previous chromosomal abnormalities.

How might the new LDTs impact the adoption of Optical Genome Mapping in clinical settings?

The new LDTs are expected to facilitate the adoption of Optical Genome Mapping (OGM) by providing comprehensive genome assessments that assist clinicians.

What are the potential risks associated with Bionano Laboratories' new tests?

Risks include the possibility that the tests may not detect structural variants as expected and challenges in funding for OGM adoption.