Kelliop is a medical diagnostics company focusing on IVD field. Kelliop’s technologies integrate lab-on-chip microfluidics, photonics, advanced material, thermal control, automation, embedded edge computing, molecular biology and biochemistry capabilities to produce a unique and valuable combination of speed, sensitivity and throughput sample-to-answer solutions for molecular diagnostic and genomics, enabled by qPCR, ddPCR, and Sequencing.
Press Releases
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- Kelliop’s new RapidSeq™ system is designed to provide healthcare professionals and lay people reliable, quick qPCR results, typically ready in 15-30 minutes for people with symptoms of multiple common respiratory viral infections, such as Covid-19, Influenza A and B, RSV, and ADV to allow fast, informed triage and treatment decisions
- At the time of announcement, Kelliop group has filed and obtained CE approval in Europe, and expect to file for FDA EUA approval, and Chinese NMPA approval shortly.
- Kelliop expects to have production capacity to manufacture 5,000-10,000 of instruments, and millions of tests available per month for the United State, EU, China, and SEA markets in 6-12 months.
- Portable instrument and small reliable disposable microfluidic cartridge are designed to be affordable and enable convenient sample-to-answer use by healthcare professionals and even untrained lay people at various point-of-care locations or in resource-limited settings.
- Test is designed for use with a nasopharyngeal swab to allow quick and convenient sample collection and minimally-invasive testing experience for patients
- Kelliop (www.kelliop.com) announced today a breakthrough multiplexed qPCR system RapidSeq™ using state-of-art microfluidic lab-on-a-chip technology, for a multiple respiratory viral infection test that is designed for use by healthcare professionals in point- of-care settings with patients experiencing symptoms of respiratory infections.
The test is designed to help healthcare professionals quickly identify SARS-CoV-2, Influenze A, Influenza B, RSV, and ADV infections, typically in 15-30 minutes, in people exhibiting symptoms of respiratory infections. It uses a simple nasopharyngeal swab sample and comes in a small, convenient kit that does not require laboratory instruments, so it can be used at various point-of- care locations close to the patient and in settings where healthcare resources are limited. The test is highly beneficial where timely decisions are needed and clinical laboratory-style PCR tests are not readily available.
As the COVID-19 pandemic persists, and the emergence of new pandemic threats such as Monkeypox, and the yearly flu season approaching, it’s becoming more and more important to increase immediate testing for all patients in multiple settings, particularly at the point of care, ER, ICU, and travel gateways, said Dr. Frank Chen, CSO of Kelliop. This new rapid multiplexed qPCR test will provide a much needed solution to the healthcare system and general public, as broad access to testing will be instrumental for returning our society to normalcy, and for timely responses for future outbreaks.
Kelliop expects to have tens of millions of RapidSeq™ Respiratory qPCR Tests available per month in the United States , EU, China, and SEA markets in 6-12 months with the capacity to produce additional volumes as needed to help address pandemic testing demand. A portable instrument in the system could be manufactured at capacity of 5,000-10,000 yearly at the same time frame. Kelliop expects to first launch in countries accepting the CE mark in end of 2022.
This test will be a valuable addition to the comprehensive Kelliop diagnostic portfolio to help healthcare systems combat disease through testing in the laboratory and at the point of care. Currently, this portfolio includes multiplexed molecular diagnostics that help diagnose and manage COVID-19 and other respiratory diseases during the initial stages of infection, during the recovery phase, as well as following the resolution of infection; the portfolio also includes cancer biomarker companion diagnosis, gastrointestinal infection, hepatitis, urinary infection, STD, and sepsis.
About RapidSeq platform
Kelliop’s RapidSeq platform is a hands-free, multiplex microfluidic testing system that could quantitatively measure 72 genetic markers simultaneously using its ultrafast 6 color fluorescence optical scanner and microfluidic chip. It has a completely sealed microfluidic lab-on-a-chip cartridge that fully automates sample preparation, nucleic acid extraction and purification, precision PCR reaction initiation and real-time measurement, all without any further human intervention, in a secure biohazard-secured cartridge.
An qPCR test detects nucleic acids that are genetic components of a pathogen and are thus very specific to that pathogen. In this case, the test would provide a qualitative “yes/no” answer on the presence of the pathogen in the patient sample and can be offered as a rapid test that is performed at the point of care. If the pathogen DNA or RNA are present in sufficient concentrations in the sample, it can be also quantitatively measured by qPCR, typically with results ready in 15 minutes, and the pathogen’s load (e.g. viral load) can be calculated very accurately at the point-of-care in real time.
In general, qPCR tests have a high specificity, they are molecular tests that amplify the target viral DNA or RNA sequence in order to generate a quantifiable signal. qPCR is one of the most sensitive tool to indicate the presence of the virus in a sample, and is considered as the gold-standard for molecular diagnosis.
Healthcare providers should visit our dedicated site for more information.
*The test has not been FDA cleared or approved or authorized. The test has been validated according to CE Mark, and CLIA (Clinical Laboratory Improvement Amendments), but FDA’s independent review of this validation is pending.
All trademarks used or mentioned in this release are protected by law. The RapidSeq Respiratory qPCR test is not available for sale in the US.
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