OnsiteGene, Inc.

• Booth: 1047

Sponsored by the NIH RADx initiative, OnsiteGene has developed “PeakV”, a next-gen PCR instrument. PeakV enables ultra-fast thermal cycling (40 cycles in 5 minutes), fully automated nested PCR, and magnetic beads based nucleic acid extraction. The low cost, contamination free Open-Assay Cartridge of PeakV has a universal assay capability, allowing third party assay developers to make their own sample-to-answer cartridge-based PCR nucleic acid tests free from any instrument design restrictions.

 Press Releases

• XDive: The World's First 5-Minute Real-Time PCR Instrument with Expansion t (Jul 13, 2024)
  OnsiteGene Inc., a member of the NIH RADx initiative, is proud to announce the launch of XDive, the world's first 5-minute real-time PCR instrument. This groundbreaking innovation completes 40 thermal cycles and real-time fluorescent imaging in just 5 minutes while maintaining sensitivity comparable to leading brands on the market.
  
  XDive offers unparalleled efficiency, capable of processing 16 samples and up to 64 multiplexing targets per run. The instrument has received FDA Emergency Use Authorization (EUA) for COVID-19 and Monkeypox testing using swab or saliva samples. XDive's editable panel technology simplifies the regulatory process for developing test kits and syndromic panels, significantly reducing time, cost, and risk.
  
  The superfast master mix used in the XDive instrument is in a dried form, allowing for easy shipping and storage at room temperature with a shelf life of 6 months.
  
  OnsiteGene has also developed the XPrep module, designed to extract RNA/DNA and seamlessly load XDive cartridges. With the XPrep module, XDive instruments provide a comprehensive and flexible sample-to-answer platform with up to 96-sample throughput, up to 256 multiplexing targets, and a 30-minute turnaround time.
  
  OnsiteGene is currently seeking distributors, licensing, and collaborators worldwide. For more information, please visit us at ADLM 2024 Booth #1047 or contact us at info@onsitegene.com.

• Xtractor: 5-minute Ultra-fast Nucleic Acid Extraction Instrument (Jul 13, 2024)
  Xtractor™ is a small, portable, fully automatic nucleic acid extraction device compatible with both ultra-fast and conventional magnetic bead methods. It efficiently extracts DNA/RNA from 1-16 respiratory samples in just 5 minutes, maintaining the sensitivity and purity performance of traditional methods. When paired with XDive™ 5-minute fluorescent quantitative PCR system, it can achieve ultra-fast PCR detection for up to 16 samples within 12 minutes, offering superior sample analysis throughput and exceptional work efficiency.
  
  Xtractor™ utilizes a fast and sensitive mechanical module for ultra-fast movement and mixing, enabling the extraction and purification steps of heating, lysis, adsorption, washing, elution, and DNA/RNA recovery in mere minutes. Its compact design, user-friendly operation, portability, and flexible throughput make it a versatile tool. It can be configured with 1-8 single-person pre-filled reagents and 96 deep-well plate pre-filled reagents (16 samples each run). Coupled with XDive™ ultra-fast PCR system, it meets the needs for instant sample detection in various scenarios.
  
  Main Product Highlights

  • Fast: Extract and purify nucleic acids from 1-16 respiratory samples in 5 minutes.
  • Flexible: Supports extraction of 1-16 independent samples (1-8 individual samples or 16 samples per deep-well plate).
  • Convenient: Built-in multiple extraction programs; one-click to complete the extraction operation.
  • Portable: Small size for easy handling in various scenarios.
  • Integrated System: With XDive™ 5-minute ultra-fast fluorescence quantitative PCR instrument, achieve 12-minute "sample-to-result" molecular detection of respiratory pathogens.

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• Ultrafast Reagent: Xfast™ HS qPCR Dried Premix (Jul 13, 2024)
  Xfast™ HS qPCR Dried Premix is a specialized reagent designed for fluorescence quantitative PCR (qPCR) using any TaqMan primer and probe set for DNA research. It supports both normal-speed and ultra-fast qPCR thermal cycling. The product contains a fast hot-start Taq enzyme and an optimized PCR buffer to effectively inhibit non-specific PCR amplification, completing 40 cycles with high sensitivity in just 5 minutes. Supplied as a dry powder, it can be transported and stored at room temperature.
  
  Xfast™ HS qPCR Dried Premix is compatible with the XDive™ 5-minute real-time PCR machine developed by OnsiteGene. It is also suitable for multiple qPCR instruments, including:

  • Thermo Fisher's QuantStudio™ 3 or 5 Real-Time PCR instrument
  • StepOne™ or StepOnePlus™ Real-Time PCR System
  • 7500/7500Fast Real-Time PCR System
  • Roche LightCycler 480 instrument
  • Bio-Rad's CFX96 Real-Time PCR instrument

  Additionally, this premix can be used with compatible real-time PCR instruments from other suppliers. It does not contain a passive reference dye, allowing the measurement of a dye in the channel typically used for the ROX™ dye.

• XDiveOne: Ultra-fast, flexible throughput, and flexible large multiplexing (Jul 21, 2024)
  Key Features:

  • 5-minute superfast real-time PCR
  • 5-minute rapid nucleic acid extraction
  • Fully automatic sample preparation, 2-minute hands-on time
  • Supports 1-256 target panel in one run
  • Simple and user-friendly interface
  • Upgradable automated nested PCR, 10~1,000 times more sensitive
  • 4 fluorescence channels, supports 1 to 16 samples in one run, with 1 sample of 256 targets and 16 samples of 16 targets each.

  XPrep Module:

  • Automated pipetting system with prepackaged reagents
  • Automates the entire process: nucleic acid extraction, sample loading, amplification reagent preparation, transfer to PCR reaction tubes, and capping
  • Processes up to 16 samples in one run
  • Uses magnetic beads to extract and purify nucleic acids
  • Completes nucleic acid purification of 16 samples in just 5 minutes
  • User-friendly software with built-in extraction programs, parameter settings, data collection, analysis, and reporting functions

  XDive Module:

  • Can be used independently as a real-time fluorescence quantitative PCR instrument, supports 1 to 16 samples in one run
  • Proprietary heating system for rapid temperature ramping and precise control
  • Completes 40 cycles of qPCR amplification, detection, and reporting in 5 minutes
  • Dried PCR premix for shipping and storage at room temperature
  • Upgradable to ultra-sensitive and fully automatic nested qPCR

  XDiveOne Compliance:

  • Globally patented, including USA, China, EU, Japan, Australia, India, and Singapore
  • TUV-certified for IEC61010 product safety and IEC61326-2-6:2020 electromagnetic safety
  • FDA EUA kits, supporting COVID-19 RT-qPCR Kit, Saliva Direct™ COVID-19 RT-qPCR Kit, MonkeyPox qPCR Kit, all of which have received FDA EUA (Emergency Use Authorization)
  • Singapore HSA approval of medical device registration
  • ISO13485 certified manufacturing facility in Singapore