Bionano Genomics Announces First Publication Demonstrating OGM as an Alternative to Karyotyping for Product of Conception Sample Analysis
Chromosomal abnormalities are the most common cause of early pregnancy loss and at least 5% of women trying to conceive face recurrent pregnancy loss with two or more consecutive miscarriages. According to current medical guidelines, KT and chromosomal microarray (CMA) can be performed on POC to determine the etiology of a loss and identify potential inherited causes. However, KT requires cultured cells, which are difficult to obtain with POC samples, and as a result, KT test failures are frequent. In addition to failing to culture, POC samples are highly heterogeneous and frequently contaminated with maternal cells, making any cytogenetic or molecular analysis challenging.
In this preliminary study, published as a preprint in medRXiv, researchers devised a novel workflow that eliminated the need for tissue culture by using OGM as an alternative to KT for comprehensive SV analysis, thereby circumventing the most common failure mode of POC analysis. Previous studies have demonstrated that OGM is highly concordant with KT, and because of its higher resolution, OGM often identifies additional genetic aberrations missed by other methods. The study workflow also describes a way to rescue samples that are contaminated with maternal cells through a combination of microdissection of formalin-fixed, paraffin-embedded (FFPE) POC samples followed by microarray analysis. OGM was not tested on the microdissected FFPE samples.
Overall, the preliminary study results showed that the new workflow using both OGM and CMA provided results in 93% of cases vs. 9.6% for workflows using KT and CMA, and identified genetic aberrations in 45.1% of samples compared to only 6.4% of samples with KT and CMA.
“POC samples are some of the most challenging samples I have ever dealt with in the lab. It’s frustrating and emotionally draining not to be able to get results to families asking why they had a pregnancy loss,” remarked Alka Chaubey, PhD, FACMG, Chief Medical Officer of Bionano. “It fills me with hope when I see indications of how OGM and other advanced molecular methods can significantly improve test success rates, and I am very proud to have worked on this approach with
This publication is available at: https://www.medrxiv.org/content/10.1101/2022.02.03.22269494v1
For more information, visit bionanogenomics.com, lineagen.com or biodiscovery.com
Forward-Looking Statements of
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” 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: how the application of OGM can significantly improve test success rates, including for POC analysis; and the ability of OGM to outperform KT in POC analysis workflows. 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: additional data from additional studies may contradict or fail to support the findings reported in this preliminary study and this press release, including with respect to the potential impact of OGM in POC analysis; the impact of the COVID-19 pandemic on our business and the global economy; changes in the competitive landscape, including the introduction of competitive technologies or improvements in existing technologies; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; whether medical and research institutions will adopt and/or continue to use our technologies, including as a result of their funding and the results of studies evaluating the utility and effectiveness of OGM; 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
+1 (858) 888-7610
+1 (858) 366-3243
+1 (503) 799-7520
Source: Bionano Genomics