LOS ALTOS, Calif. July 28: OnsiteGene, Inc., a member of the NIH RADx initiative, today announced the global commercial availability of XDive®, the world’s first real-time PCR system to complete 40 thermal cycles with real-time fluorescent imaging in approximately five minutes — without compromising accuracy or sensitivity. The company also announced that an XDive system has been deployed at the Wyss Institute for Biologically Inspired Engineering at Harvard University to support advanced medical research. In addition, the platform is being deployed at scale for forensic testing applications.
Deployed at the Wyss Institute for advanced medical research
At the Wyss Institute at Harvard University, an XDive system has been installed to support advanced medical research programs. Through the Wyss Instrumentation Program, the system will be evaluated for both speed and laboratory-grade accuracy. The deployment places OnsiteGene’s ultra-fast PCR technology in one of the world’s leading bioengineering research environments, where rapid, sensitive nucleic acid analysis can accelerate the pace of discovery.
Scaling into forensic testing
Separately, XDive is being deployed at scale for forensic testing. Forensic DNA analysis has traditionally required hours of laboratory processing, a constraint that limits how quickly investigative decisions can be made. XDive’s five-minute real-time PCR, combined with room-temperature-stable reagents and automated sample-to-answer workflows, brings laboratory-grade results into a timeframe and footprint suited to high-throughput forensic operations.
“Having XDive placed at a premier biomedical research institute and additionally scaling into forensic testing shows the breadth of what the platform can do,” said Yanhui Liu, PhD, Chief Executive Officer of OnsiteGene. “Wherever the work is time-critical — in the research lab or the forensic lab — five-minute PCR changes what is possible. The science no longer has to wait on the instrument.”
A breakthrough in speed and multiplexing
XDive integrates proprietary high-speed thermal cycling, advanced fluorescence optics with four to six optical channels, and room-temperature-stable dried reagents into a compact benchtop system. Each run processes up to 16 samples with a total of 64 to 96 targets per run — four to six targets per tube in multiplex — delivering results faster than any commercially available PCR instrument. The system supports both OnsiteGene’s Xfast dried reagents and conventional qPCR chemistries, offering open-platform flexibility for assay development and regulatory submissions.
Key innovations include a proprietary thermal block and sensor technology enabling exceptional ramp rates and thermal precision; dried, room-temperature-stable reagents with a six-month ambient shelf life that eliminate cold-chain requirements; an intuitive software interface; and open-platform compatibility that accelerates both research and IVD workflows. For sample-to-answer automation, XDive pairs with OnsiteGene’s Xtractor® or Xprep modules, enabling fully automated testing from raw sample to result in 12 to 15 minutes — well suited to point-of-care and decentralized settings.
Proven and certified
XDive has held FDA Emergency Use Authorizations for COVID-19 and Mpox testing and is actively expanding into syndromic testing applications. Its performance has been validated with Professor Carl Wittwer, co-founder of BioFire/FilmArray, and it is protected by granted patents in the United States, China, the European Union, Japan, Australia, India, and Singapore. The platform is ISO13485 certified, and its OEM-ready modular design supports integration into third-party systems and flexible deployment across laboratory, clinical, and mobile environments.
OnsiteGene is actively seeking global distributors, licensing partners, and assay-development collaborators, and is demonstrating XDive — alongside its newly introduced handheld myNAT™ PCR instrument and Xlyser™ ultrasound lysis device — at Booth #2168 throughout ADLM 2026.
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