Case Study: OnsiteGene
OnsiteGene
Utilizing our scientific know-how and research experience to bring the XDive, the fastest real-time qPCR instrument on the planet, to clinical practice. Bridging the XDive to other testing methods to expand its possibilities for clinical use.
SECTOR:
Technology
LOCATION:
San Diego, CA
KEY ACHIEVEMENT:
OnsiteGene is an early-stage biomedical technology company that develops extraordinarily fast genetic testing instruments capable of executing 40-cycle real-time qPCR in just a few minutes. With their revolutionary testing devices, OnsiteGene aims for patients to be able to access accurate results and obtain treatment the same day they visit a healthcare provider.
After OnsiteGene created the XDive Superfast Real-Time PCR System, they knew it would be highly advantageous for clinical diagnostics. The device features state-of-the art technology, user-friendly software, affordable superfast PCR consumables and reagents, and it is possibly the fastest real-time PCR instrument on the planet to date. However, in order to reach patients with their new technology, OnsiteGene needed to find a laboratory that could validate their instrument and assay for clinical use.
OPPORTUNITY
Seeing as Neelyx Labs shares OnsiteGene’s primary goal of providing rapid, accurate diagnostics to patients, it was an easy decision for us to collaborate. Our research experience and understanding of molecular biology was another factor that made OnsiteGene choose us over other clinical laboratories. This proved to be invaluable as we were not only able to validate the XDive, but we also made key modifications to optimize its efficiency and accuracy. Additionally, Neelyx Labs expanded the possibilities for the XDive instrument by bridging it to other testing methods such as the SalivaDirect protocol.
SOLUTION
QUALITY
Clinical Validation
We prepared and performed all necessary validation procedures and submitted all necessary paperwork to clinically validate the XDive and the OnsiteGene assay, (OnsiteGene’s primary goal).
Continuous Collaboration
As we worked to develop the best assay possible for the XDive instrument before validation, we remained in constant communication with OnsiteGene to provide updates and exchange ideas.
R&D Prioritization
We prioritized working on the XDive and its validation even while receiving high sample volumes daily, understanding the importance of research and development for diagnostics in the long run.
INNOVATION
Improving Accuracy
Utilizing our scientific background and research experience, we were able to make modifications to the OnsiteGene assay and XDive instrument settings to improve accuracy for testing clinical samples.
Optimizing Affordability
As Neelyx Labs and OnsiteGene both wanted to prioritize affordable testing, we made sure to use inexpensive consumables and reagents in finalizing the OnsiteGene assay.
Maintaining Speed
Since the XDive is possibly the fast real-time qPCR instrument on the planet, it was crucial to not sacrifice a fast run time. We were able to validate the XDive while keeping its run time under 30 minutes.
SERVICE
Patient-First Development
With much uncertainty at the beginning of the MPOX outbreak, we knew we needed to develop a testing option that offered the fastest results possible. Utilizing the XDive for MPOX testing was the natural solution.
Wide Reach
Validating the XDive to be a part of the SalivaDirect workflow greatly expanded its reach as a COVID-19 testing instrument. This will allow for more clinical laboratories to offer very fast COVID-19 results to their patients.
Open-Source
OnsiteGene and Neelyx Labs prioritized open-source, open-platform technology when validating the XDive. This means that the software is freely available and may be modified as needed by anyone.
“We initially partnered with Neelyx Labs to validate our super fast real-time qPCR instrument, the XDive, for COVID-19 testing. Neelyx not only validated the XDive, but they utilized their research background and expertise in molecular diagnostics to optimize our assay and instrument specifications for the clinical setting. They took the initiative to develop and validate an MPOX assay on the XDive and also bridge the XDive to SalivaDirect, greatly expanding the XDive’s clinical possibilities. We thought we needed a clinical lab, but what we actually wanted was Neelyx.”
— Yanhui Liu, PhD - OnsiteGene CEO
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