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
for Standardization. It was set up in
1947 and is located in Geneva, Swit-
zerland. Its purpose is to facilitate
and support international trade by
developing standards that people
everywhere would recognize and re-
spect. The eight quality management
principles - Leadership, involvement
of people, process approach, system
approach to management, continual
improvement, factual decision- mak-
ing, supplier relationships, customer
focused are interlinked.
ISO 9001:2008 retains the generic
nature wherever applicable to all
sizes and types of organizations oper-
ating in any sector. ISO13485 was
developed by ISO Technical Commit-
tee 210. ISO/TC 210 is responsible
for quality management and corre-
sponding general aspects for medical
devices.
The CE marking stands for
Conformitẻ Europẻenne which is a
Euroepan mark of conformity indica-
tion that a product or system to
which it is applied. It complies with
the applicable European laws
(Directives) regulating a necessary
level of protection with respect to
safety, health, environment and con-
sumer protection.
Match the following diagnostic company with their respective products
Diagnostic company
1 ReaMetrix
2 Accuri
3 Evogen
4 Picoscope vehicle diagnostics
5 Biomedica Diagnostics
2 We welcome your feedback, write to us at readigest@reametrix.com
With the passing of the European direc- At ReaMetrix,
tive on in vitro diagnostic medical de-
Our vision is ‘One world One Quality’.
vices (IVDD 98/79/EC), the require-
Our reagents are globally relevant and
ments of in vitro diagnostic medical
our Dry Tri T-STAT is the first CD4
devices are binding for all member
enumeration reagent in a dried- down
states of the European Union. The di-
format to have US FDA clearance and
rective includes product requirements,
CE marking as well. All reagents at
requirements on manufacture, placing
ReaMetrix are manufactured using a
the product on the market, as well as
ISO9001-2008 cleared process that
demands on safety and quality of the
ensures the highest international stan-
products.
dards of quality.
The IVDD does not apply to interna-
In fact, our robust quality control fol-
tionally certified reference materials,
lows all through the manufacturing
materials used for external quality as-
process from the optimum selection of
sessment schemes, home brew products,
the right dye molecules and antibodies
products for general laboratory use and
(with the highest affinity, the right
devices for research purposes.
dye to protein ratio and the right com-
In vitro diagnostic products (IVDs), as bination of antibody concentrations
defined in ξ21 CFR 809.3(a), are those required to achieve saturated labeling
reagents, instruments, and systems for the cell count range in the sample)
intended for use in the diagnosis of to the dried-down labeled product that
disease or other conditions including a reaches the customer. QA/QC is very
determination of the state of health, in well regulated over many batches pre-
order to cure, mitigate, treat, or pre- venting the batch to batch variability
vent disease or its sequealae. and thus providing ease of perform-
ance to the customers.
Food and Drug Administration (FDA)
expects the manufacturer’s choice of
procedures and processes rely on the
FDA guidelines and thus ensures safety
To know more about our quality re-
and effectiveness of the IVDs.
agents please visit,
www.reametrix.com
Brain Gym
Product
a C6 Flowcytometer
b ReaPan S34
c QuickCoag Reagents
d Ultra-Rapid PCR
e Oscilloscope technology
 Commitment to Quality at ReaMetrix
We at Reametrix,
believe that process control is a criti-
cal component of generating high
quality data and products. Our corpo-
rate infrastructure is process-
centric, and we live by our philosophy
on a daily basis. Rigorous documenta-
tion, full audit trails, and a dedicated
quality group result in high quality
products, and reproducible, trustwor-
thy data. At ReaMetrix, Process is
our Product. Our primary focus is to
apply Six Sigma product development
Some Highlights
ISO 9001 2008 Certified
Six Sigma Product Development
Strategies
Full Audit trails for product develop-
ment and contract research projects
GMP level manufacturing processes
strategies to diagnostic and life sci-
ence products.
In addition to quality, process control
can be applied to cost management.
With a robust and repeatable proce-
dure it is possible to optimize the
selection of dyes to include newer
candidates free of intellectual prop-
erty constraints.
Reametrix brings in the vision of quality, test and ensure that quality can be
affordable diagnostics without compro- monitored from manufacture to the
mising on science. We follow a good end-user.
documentation system and customer
For more information on FIND malaria
management cell which caters the needs
program please visit
of the customers in a very efficient
way. Our commitment to provide quality www.finddiagnostics.org
diagnostic reagents is reflected in every
successful project that we are part of,
like the one with FIND
We partner with,
‘FIND malaria program’ in collaboration
with WHO. The program necessitates
high quality diagnosis and reporting
of incidence rates in order to determine
which interventions are working effec-
tively and how much malaria is still
around.
Ensuring accurate diagnosis saves lives
by guiding correct treatment, and dem-
onstrating accuracy gives both health
workers and patients the assurance
necessary to base treatment on the
rapid diagnostic tests (RDT) result. Lack
of confidence in results is a major im-
pediment to current RDT-based pro-
grams.
It is vital that RDT quality can be
checked and assured at the level of
their use. We are working with FIND to
develop stable positive control wells for
malarial RDTs. When available, these
will provide a simple, low-cost method to
If you would like to discontinue receiving this communication please write to readigest@reametrix.com