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ADV
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rapid access to actionable diagnostic information
PCR|ONE rapid DNA/RNA detection system receives European CE-IVD certificate for its MRSA/MSSA panel
PCR|ONE is a fast, benchtop, point-of-need DNA/RNA detection diagnostic device
MARKET READY - PCR|ONE already validated inclinical environment
ATTRACTIVE CARTRIDGE TRANSFER COST enablesPCR|ONE accessibility across multiple market segments
PCR|ONE offers fully automated analysis in SAMPLE-IN- ANSWER-OUT format with ONLY 3 SIMPLEMANUAL STEPS
PCR|ONE spatial arraying allows for 20 GENETICTARGETS IN A SINGLE TEST
PCR|ONE can provide sample-to-result testing within15 MINUTES (TAT), with negligible time-between-tests
PHYSICAL MULTIPLEXING ENABLES FAST ADOPTIONTO MUTATIONS (easy to modify or add new reactions)
PCR|ONE ideally integrates into the laboratoryenvironment, offering minimum hands-on time,a rapid response to urgent testing needs, andefficient use of bench space.
DISRUPTIVE TECHNOLOGY AWARD 2019 -SEMI-FINALIST
MRSA / MSSA15 min TATmultiplex
Market ready H1 2021
PANEL
Clinical evaluation*
MRSA / MSSA – clinical panel evaluation (2021)
The MRSA/MSSA assay, performed on PCR|ONE system is a qualitative in vitrodiagnostic test for detection of methicillin-resistant Staphylococcus aureus (MRSA)and Staphylococcus aureus (MSSA) DNA directly from nasal swabs. The test utilizesautomated real-time polymerase chain reaction (PCR) for the amplification and detectionof MRSA/MSSA-specific DNA. The MRSA/MSSA assay is intended to aid in the preventionand control of MRSA/MSSA infections in healthcare settings.
PCR|ONE SARS-CoV-2 qualitative clinical panel
PCR|ONE SARS-CoV-2 assay for use with PCR|ONE system is a rapid real-time ReverseTranscription Polymerase Chain Reaction (real-time RT-PCR) test intended for thequalitative detection of nucleic acid from the SARS-CoV-2 in nasal swab specimencollected from individuals with signs and symptoms of infection who are suspected ofCOVID-19.
SARS-CoV-215 min TATmultiplex
Market ready H1 2021
PANEL
PCR|ONE SARS-CoV-2 panel CE-IVD coming soon
SARS-C
OV-2
MRS
A/M
SSA
MRSA / MSSA panel receives CE-IVD certificate
MRSA MSSA
95% 100% 96.8% 97.1%
sensitivity specificity sensitivity specificity
As a part of the EAP we would like to introduce PCR|ONE MRSA/MSSA and SARS-CoV-2 panels to the EU/US marketsin order to obtain data and information necessary for the continuous improvement of our system.
EARLY ACCESS PROGRAMME
we want to establish cooperation with key
reference and opinion-forming centers
we want to define the most important market needs and prepare appropriate tools to our GO to Market approach
we want to establish strong distribution network in the
EU and US
we want to launch PCR|ONE system in Q4 2021
EARLY ACCESS PROGRAMME
PARTNERSHIP DISTRIBUTION NETWORK MARKET LAUNCHFIELD TESTING
MARKET EMPTY ZONE – COMBINATION OF SPEED AND MULTIPLEXING
15 min
DEGREE OF MULTIPLEXING
SPEE
D O
F AN
ALYS
IS
FUNCTIONALITY AREA OF OTHER SYSTEMSAVAILABLE ON THE MARKET
unique combinationof speed and multiplexing
Curiosity DiagnosticsDuchnicka 3 bldg. 1601-796 Warsaw, Poland
Business Development InquiriesGajane Żurawska, Global Business Development [email protected]
Edward GreyManaging Director Clairfield [email protected]
*Curiosity Diagnostics data on file. April 2021
www.curiositydiagnostics.comwww.scopefluidics.com
PCR|ONE offers a high degree of multiplexing, that allowscomposing diagnostic panels tailored for various clinicalapplications
PCR|ONE is a versatile platform for development of user-specific and cost-effective point-of-need panels
Physical multiplexing allows for fast expansion andadaptation of the assay panels in response to changingneeds and epidemiological landscape
The ultra-fast and fully automated workflow is compatiblewith multiple use scenarios
Load sample into cartridgeloading sample is easy (insert, break the swab, close container) and minimizes chances of error or contamination
STEP 1
STEP 2
STEP 3
Insert cartridge into deviceloading drawer is accessible and keeps the cartridge stable
Start the testresults will be available on a screen, in a printed form or via LIMS compatible distribution (possible to integrate LAN/wireless)
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PCR|ONE
AQS-
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53 M
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