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At JPM: PacBio Turns Attention to LDTs

By Allison Proffitt 

January 21, 2025 | PacBio’s president Christian Henry gave the sequencing company’s 43rd Annual J.P. Morgan Healthcare Conference address last week. And while Oxford Nanopore and Illumina both doubled down on proteomics and a multi-omic future, Henry stayed focus on PacBio’s mission to enable the promise of genomics to better human health.  

PacBio’s goals for 2025 are to drive innovation, expanding to a multi-platform portfolio, improve efficiency and reduce costs, and explore emerging HiFi applications—including clinical laboratory-developed tests (LDTs).  

Building a Product Portfolio  

Over the past two years, the company has been aggressively updating its sequencing fleet. “PacBio provides a comprehensive portfolio from end-to-end, from sample-to-answer, of long and short read sequencing technologies,” he said. In 2023, PacBio launched the Revio long read platform and the Onso short read program. In 2024, the desktop Vega.  

Vega—which exceeded Henry’s November 2024 predictions and sold 7 units before the end of the year—sells for $169,000 and serves a market of desktop customers, which Henry estimates is over $1 billion. “We had double-digit orders,” Henry said. “The truth is we could only ship seven; that’s all the units we had available to ship.” Scaling the Vega pipeline is a top priority, Henry added. There are “hundreds” of interested customers, he reports, the majority are new to PacBio. “70% of those opportunities are brand new customers. That’s actually, for me, a very exciting metric.” Vega will widen the company’s reach, Henry said, “so that we can get more customers leveraging HiFi technology, creating new applications, because that’s what happens when you have new customers testing or using the technology.”  

The real “watershed moment” for PacBio in 2024 came on the clinical side of the business, Henry said. He listed “just a few” customers who adopted HiFi long reads in their clinical work including Quest Diagnostics, Myriad Genetics, Bioscientia, Radbound University Medical Center, J. Craig Venter Institute, and Berry Genomics.  

These customers are adopting long read sequencing and HiFi reads in products like targeted panels for neurological disorders, carrier screening, neurosensory disorders, and whole genome sequencing for rare disease.  

“Revio and now Vega are replacing legacy technologies and enabling new insights and new clinical opportunities that didn’t exist before because the technology wasn’t there,” Henry said. PacBio has taken notice of these customers’ success. “We’ve taken this momentum… and we intend to develop and launch an IVD solution,” Henry said, aligned to the FDA final rule stage 4 on laboratory developed tests.  

Much of the pipeline is already in place, he said: the Nanobind PanDNA test for saliva/buccal extraction, PureTarget panel of gene targets, and the Vega desktop sequencer would also work well in a clinical setting. PacBio is pursuing a premarket approval for high-risk LDTs (not expected before October 2027) and 501(k) or de novo submission for low- to moderate-risk LDTs (not expected before April 2028). “We’ll be working with partners to develop IVD-driven assays so that we can have an FDA-cleared instrument by the time the stage for market approval is required,” Henry said. “This is an important strategic priority for the company because we do think the Vega system has applications across a wider array of clinical areas.”  

For more on PacBio’s 2025 goals and 2024 achievements, see the story at Bio-IT World.  

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