LOS ALTOS, Calif. July 28: OnsiteGene, Inc., a member of the NIH RADx initiative, today introduced a complete sample-to-answer molecular testing workflow that pairs its handheld Xlyser™ ultrasound lysis device with the XDive® ultra-fast real-time PCR system. Together, the two instruments take a raw sample to a molecular result in approximately twelve minutes, processing up to 16 samples per run at laboratory-grade sensitivity. Both devices are commercially available, and the workflow is being demonstrated at the 2026 Association for Diagnostics & Laboratory Medicine (ADLM) meeting.
Where handheld molecular testing trades throughput for portability, the Xlyser + XDive workflow is built to deliver both: the one-minute, laboratory-independent sample preparation of a point-of-care device, feeding directly into a benchtop instrument that runs 40-cycle PCR in about five minutes across up to 16 samples. It is a sample-to-answer solution for laboratories, clinics, and high-throughput settings that need speed without sacrificing capacity.
Four steps, about twelve minutes, up to 16 samples
Xlyser converts a raw sample into PCR-ready lysate in about one minute, using high-efficiency ultrasound that cracks even hard-to-lyse organisms while fully inactivating pathogens — with no centrifuge and no purification. The lysate is loaded into XDive, which completes a full 40-cycle real-time PCR run in approximately five minutes, with real-time fluorescent imaging across four to six optical channels. Lyse, load, amplify, answer — roughly twelve minutes from raw sample to result, for as many as 16 samples and up to 96 targets in a single run.
The world’s first 5-minute PCR, fed by one-minute sample prep
XDive integrates proprietary high-speed thermal cycling, advanced fluorescence optics, and room-temperature-stable dried reagents into a compact benchtop system, completing 40 thermal cycles with real-time imaging in approximately five minutes — faster than any commercially available PCR instrument — without compromising accuracy or sensitivity. It is an open platform, running both OnsiteGene’s dried reagents and conventional qPCR chemistries, and its performance has been validated with Professor Carl Wittwer, co-founder of BioFire/FilmArray.
Xlyser complements XDive at the front end, delivering materially higher nucleic acid yield than bead-beating or thermal lysis, with full pathogen inactivation and low-cost disposable lysis tubes. By removing the centrifuge, the purification step, and the cold chain from the front of the workflow, it turns XDive’s five-minute PCR into a genuine sample-to-answer capability. For fully automated operation, XDive also pairs with OnsiteGene’s Xtractor® extraction module.
Availability
Both Xlyser and XDive are commercially available now and are intended for research use only. Neither is cleared or approved for diagnostic use. OnsiteGene is accepting orders and evaluation inquiries at info@onsitegene.com.
OnsiteGene is seeking distributors, licensing partners, and assay-development collaborators worldwide, and is demonstrating the Xlyser + XDive workflow — alongside its newly introduced handheld myNAT™ PCR instrument — at Booth #2168 throughout ADLM 2026. Hands-on demonstrations are available at the booth.
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