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Focus of the month

ReaDigest Quality Diagnostics

Vo l u m e 1 , I s s u e 4 1 0 o f J a n2 0 1 0
Wishing you all

“A very
Happy New Year”

esk
O’ s D Dear friends,
E
ReaMetrix employs a
m C
highly process driven, Fro Wishing you all a very joyful and successful 2010.
cost-efficient I am pleased to share with you another exciting
approach to product milestone in our journey to make innovative and affordable diagnostic
development.
products. We have entered into an agreement with BD Biosciences where
We not only make ReaMetrix will develop and supply reagents to enumerate CD4 and %CD4, in
products that are ReaMetrix's room temperature stable, dried-down reagent format, for the
more applicable to the
FACSCount platform. BD and ReaMetrix entered into this agreement after
Indian market, but we
an extensive validation of ReaMetrix's manufacturing processes and
do it better, resulting
in higher quality reagents.
products. For more To read the press release, please find the PDF attachment alongside
information on
Process Control at Through this, ReaMetrix will be able to have access to BD's extensive global
ReaMetrix, please network of FACSCount instruments and increase the access for diagnosis in
visit. resource poor settings. This agreement is in effect for the %CD4 reagents
To learn more about on the FACSCount platform only and does not prevent ReaMetrix in any way
us from supporting its existing flow based products on
Contact us
any system.

ReaMetrix India Pvt. Ltd, We wanted to share this good news with you and
50 B, 2nd Phase, TVS thank you for your trust in ReaMetrix's products. Your
Cross, Peenya Industrial
support has ensured that we are motivated to achieve
A r e a , P e e n y a
Bangalore- 560 058 these milestones which make ReaMetrix the innovation
India. leader that it is today.
Phone: +91 80 2837
We look forward to your continued support while we
8693
hope to learn and grow with you. Dr. Bala S. Manian
Fax : +91 80 4117 2451

PTO to find Do you know?


Quality standards in 2 The terms ‘quality assurance’ and ‘quality control’ are often used interchangeably to refer to ways of ensur-
diagnostics– A brief
ing the quality of a service or product. The terms, however, have different meanings.
overview
Assurance: The act of giving confidence, the state of being certain or the act of making certain.
Brain Gym 2
Quality assurance:
Commitment to 3 An overall management plan to guarantee the integrity of data (The “system”)
Quality at RMx
Control: An evaluation to indicate needed corrective responses; the act of guiding a process in which vari-
ability is attributable to a constant system of chance causes.
Quality control:
To know the answers for
‘Brain Gym’, log onto A series of analytical measurements used to assess the quality of the analytical data (The “tools”)
readigest.reametrix.com
1
Quality Standards in Diagnostics – A Brief overview
ISO is the International Organization With the passing of the European direc- At ReaMetrix,
for Standardization. It was set up in tive on in vitro diagnostic medical de-
Our vision is ‘One world One Quality’.
1947 and is located in Geneva, Swit- vices (IVDD 98/79/EC), the require-
Our reagents are globally relevant and
zerland. Its purpose is to facilitate ments of in vitro diagnostic medical
our Dry Tri T-STAT is the first CD4
and support international trade by devices are binding for all member
enumeration reagent in a dried- down
developing standards that people states of the European Union. The di-
format to have US FDA clearance and
everywhere would recognize and re- rective includes product requirements,
CE marking as well. All reagents at
spect. The eight quality management requirements on manufacture, placing
ReaMetrix are manufactured using a
principles - Leadership, involvement the product on the market, as well as
ISO9001-2008 cleared process that
of people, process approach, system demands on safety and quality of the
ensures the highest international stan-
approach to management, continual products.
dards of quality.
improvement, factual decision- mak-
The IVDD does not apply to interna-
ing, supplier relationships, customer In fact, our robust quality control fol-
tionally certified reference materials,
focused are interlinked. lows all through the manufacturing
materials used for external quality as-
process from the optimum selection of
ISO 9001:2008 retains the generic sessment schemes, home brew products,
the right dye molecules and antibodies
nature wherever applicable to all products for general laboratory use and
(with the highest affinity, the right
sizes and types of organizations oper- devices for research purposes.
dye to protein ratio and the right com-
ating in any sector. ISO13485 was
In vitro diagnostic products (IVDs), as bination of antibody concentrations
developed by ISO Technical Commit-
defined in ξ21 CFR 809.3(a), are those required to achieve saturated labeling
tee 210. ISO/TC 210 is responsible
reagents, instruments, and systems for the cell count range in the sample)
for quality management and corre-
intended for use in the diagnosis of to the dried-down labeled product that
sponding general aspects for medical
disease or other conditions including a reaches the customer. QA/QC is very
devices.
determination of the state of health, in well regulated over many batches pre-
The CE marking stands for order to cure, mitigate, treat, or pre- venting the batch to batch variability
Conformitẻ Europẻenne which is a vent disease or its sequealae. and thus providing ease of perform-
Euroepan mark of conformity indica- ance to the customers.
Food and Drug Administration (FDA)
tion that a product or system to
expects the manufacturer’s choice of
which it is applied. It complies with
procedures and processes rely on the
the applicable European laws
FDA guidelines and thus ensures safety
(Directives) regulating a necessary To know more about our quality re-
and effectiveness of the IVDs.
level of protection with respect to agents please visit,
safety, health, environment and con-
sumer protection. www.reametrix.com

Brain Gym
Match the following diagnostic company with their respective products

Diagnostic company Product

1 ReaMetrix a C6 Flowcytometer

2 Accuri b ReaPan S34

3 Evogen c QuickCoag Reagents

4 Picoscope vehicle diagnostics d Ultra-Rapid PCR

5 Biomedica Diagnostics e Oscilloscope technology

2 We welcome your feedback, write to us at readigest@reametrix.com


Commitment to Quality at ReaMetrix
We at Reametrix, Reametrix brings in the vision of quality, test and ensure that quality can be
affordable diagnostics without compro- monitored from manufacture to the
believe that process control is a criti-
mising on science. We follow a good end-user.
cal component of generating high
documentation system and customer
quality data and products. Our corpo- For more information on FIND malaria
management cell which caters the needs
rate infrastructure is process- program please visit
of the customers in a very efficient
centric, and we live by our philosophy
way. Our commitment to provide quality www.finddiagnostics.org
on a daily basis. Rigorous documenta-
diagnostic reagents is reflected in every
tion, full audit trails, and a dedicated
successful project that we are part of,
quality group result in high quality
like the one with FIND
products, and reproducible, trustwor-
thy data. At ReaMetrix, Process is We partner with,
our Product. Our primary focus is to
‘FIND malaria program’ in collaboration
apply Six Sigma product development
with WHO. The program necessitates
high quality diagnosis and reporting
Some Highlights
of incidence rates in order to determine
ISO 9001 2008 Certified which interventions are working effec-
tively and how much malaria is still
Six Sigma Product Development
around.
Strategies
Ensuring accurate diagnosis saves lives
Full Audit trails for product develop-
by guiding correct treatment, and dem-
ment and contract research projects
onstrating accuracy gives both health
GMP level manufacturing processes workers and patients the assurance
necessary to base treatment on the
rapid diagnostic tests (RDT) result. Lack
strategies to diagnostic and life sci- of confidence in results is a major im-
ence products. pediment to current RDT-based pro-
In addition to quality, process control grams.
can be applied to cost management. It is vital that RDT quality can be
With a robust and repeatable proce- checked and assured at the level of
dure it is possible to optimize the their use. We are working with FIND to
selection of dyes to include newer develop stable positive control wells for
candidates free of intellectual prop- malarial RDTs. When available, these
erty constraints. will provide a simple, low-cost method to

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