How the CLART® technology works?

“CLART® Clinical Array Technology.
Clinical daily use of low density microarrays”
José Luis Lafarga López
Area Manager
GENOMICA SAU
GENOMICA S.A.Unip.

Personnel: 60 employees.

Selling CLART microarray for IVD purposes since 2005.

Export activities started in 2006.

Present in more than 35 countries.
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Branch office in Scandinavia.
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Representative Office in China.
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Quality management:
• ISO 9001:2008 certified company for all its activities.
• ISO 13485:2003 certified company for manufacturing of IVD products.
• CE-Marked IVD products.
GENOMICA S.A.Unip.

HPV
PRODUCTOS
• Human Papilloma Virus 35
genotypes
EnteroBac
• 19 bacteria which cause
infectious diarrhea
STIs
• 18 main organism
responsible for sexually
transmitted diseases.
Pneumovir
• 17 human viruses which
cause respiratory
infections
SeptiBac
• 5 fungus, 16 bacteria
Gram+ and 12 bacteira
Gram- which cause Sepsis
Pneumo CLART
bacteria
• 11 bacteria which cause
respiratory infections.
Entherpex
• human herpes viruses and
enteroviruses
CMA
• 15 mutations implied in
colorectal cancer
OEM
• Your kit here
1. How the CLART® technology works?
2. Are the results accepted clinically and approved
to be used in routine diagnostics?
3. Why this technology is improving the actual
results of a Lab?
How the CLART® technology works?
1 sample
1 test, controls included
The entire spectrum of targets
suspected by clinicians
Positive/Negative per target
Clinical Diagnostic use
How the CLART® technology works?
1. Amplification
Ampl.Tubes Ready to use
Controls included
No mix preparation
Enzyme included
Multiplex PCR
PCR equipments compatible
Just add the
extracted sample !
How the CLART® technology works?
2. Visualization
CMV
Detection probes
for CMV
How the CLART® technology works?
3. Reading
Automatic
LIMS connection
Objective
Data stored
Export
Print
How the CLART® technology works?
What do you need?
What do you receive?
a Mol. Lab
a reduction on the cost per target
a PCR equipment.
a reduction on the hands on
work per sample.
a CAR (Clinical Array Reader), an
affordable, unexpensive equipment.
Plug and play.
a entire view of the targets that
could be implicated clinically.
a technician to run the test (ready to
use, low hands on time, intuitive and
easy)
a better and most complete
diagnostic, really welcome by
clinicians.
Are the results accepted clinically and
approved to be used in routine diagnostics?
Yes, it is validated by the Spanish, European and Canadian Authorities as a
CE-IVD product to be used in routine diagnostics,
Quality has always been our priority. GENOMICA is running nowadays
registration of our products worldwide and we are satisfactorily approved and we
are allowed to distribute our products in more than 40 countries.
ISO 13485:2012
CMDCAS,
Canada
ISO 17025:2005
ISO 9001:2008
Are the results accepted clinically and
approved to be used in routine diagnostics?
Are the results accepted clinically and
approved to be used in routine diagnostics?
We run succesful clinical comparison with long-term previously
stablished kits in the market…………
Are the results accepted clinically and
approved to be used in routine diagnostics?
And we have numerous evidences that prove the clinical relevance
and applicability of our diagnostics.
Are the results accepted clinically and
approved to be used in routine diagnostics?
Fig. 2: Clinical performance of
genotyped specimens
Primary
screenings
Clinical data
Patient History
Are the results accepted clinically and
approved to be used in routine diagnostics?
We are part of important International studies, being our results a
substantial information to complete the characterization of the samples.
Are the results accepted clinically and
approved to be used in routine diagnostics?
GENOMICA takes part in several international projects
Are the results accepted clinically and
approved to be used in routine diagnostics?
In terms of quality, we are constantly improving, facing the World Health
Organization Quality panels and other renowned QC panels satisfactorily:
Why this technology is improving the
actual results of a Lab?
Less hands on time
Objective results (No user interpretation).
Friendly platform, easy to use
Results easily manage in files.
Full automation available
Sensitivity and specificity values confirmed by the WHO panels.
Reagents completely ready to use.
Available to be installed in a wide range of labs (small lab, hospital labs,
reference labs…).
No need of Equipment maintenance.
Why this technology is improving the
actual results of a Lab?
Specific software included.
Technical service of reagents and equipment included.
Coinfections detected.
Better and more accute diagnostic.
To confirm positives and to discard suspicions at once.
Follow up closely the clinical evolution of the patient.
Very low volume of primary sample used: more results obtained in difficult
patients as newborns, transplants…. And with challenging samples as CSF.
Genomic and amplification controls included “in the test”, no need to waste
more tests to run the controls.
Thank you very much !!