Why Bionano Isn’t in the Club Yet Unlike se
Post# of 82
(Total Views: 37)
Posted On: 07/21/2025 2:24:38 PM
Why Bionano Isn’t in the Club Yet
Unlike sequencing incumbents, Bionano isn’t just optimizing, it’s relacing. Established players have lobbying power, legacy CPT codes, and cozy workflows.
Bionano Genomics’ OGM will replace outdated tools like karyotyping and FISH, disrupting entrenched giants. The fact that OGM is already being used in China and Europe suggests credibility, but the FDA’s conservatism lags behind. This international momentum could pressure the FDA to act, but it’s not a guarantee. The agency tends to move cautiously, especially when a technology threatens to redefine diagnostic standards
Pioneering a new standard is a big part of the challenge. But it’s also fair to say that industry inertia and entrenched interests create friction. If Bionano succeeds, it won’t just be a regulatory win, it’ll be a tectonic shift in how we see the genome.
Unlike sequencing incumbents, Bionano isn’t just optimizing, it’s relacing. Established players have lobbying power, legacy CPT codes, and cozy workflows.
Bionano Genomics’ OGM will replace outdated tools like karyotyping and FISH, disrupting entrenched giants. The fact that OGM is already being used in China and Europe suggests credibility, but the FDA’s conservatism lags behind. This international momentum could pressure the FDA to act, but it’s not a guarantee. The agency tends to move cautiously, especially when a technology threatens to redefine diagnostic standards
Pioneering a new standard is a big part of the challenge. But it’s also fair to say that industry inertia and entrenched interests create friction. If Bionano succeeds, it won’t just be a regulatory win, it’ll be a tectonic shift in how we see the genome.
(0)
(0)