Bionano study shows gene editing detection capabilities

Bionano Genomics Inc. (NASDAQ: BNGO) announced that researchers from the Sanford Burnham Prebys Medical Discovery Institute published a study in Molecular Therapy - Methods & Clinical Development examining the use of optical genome mapping to detect genomic alterations from gene editing technologies.

The study analyzed human induced pluripotent stem cell lines before and after treatment with different gene editing methods, including transposons, lentiviral transduction, and CRISPR-Cas9-mediated locus insertion. The research found that optical genome mapping could detect large genomic rearrangements and structural variants with sensitivity to variant allele fractions as low as 5%.

According to the study, the number of transgene insertions varied by editing technology. Transposons or lentiviral transduction resulted in multiple transgene insertions in the genome, while CRISPR-Cas9 technology produced more precise and limited transgene insertion. The research indicated that optical genome mapping revealed previously undetected structural rearrangements and copy number changes present only in engineered cells.

"This study shows that optical genome mapping can uncover relevant structural variants and rearrangements that other methods miss, which supports the integration of OGM as a complementary QC tool to strengthen confidence in genome integrity, genetic fidelity, and long-term stability of edited cell lines in therapeutic development pipelines," said Erik Holmlin, president and chief executive officer of Bionano.

The study suggested that optical genome mapping could serve as a quality control tool for cell-line genome integrity in pre-clinical and clinical development of gene editing therapies. The research indicated that editing processes can introduce genomic alterations that may escape detection by traditional methods.

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