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CE2012 – Thursday 20 September
The In Vitro Diagnostics View
Doris-Ann Williams
Chief Executive, BIVDA
CC
Celebrating 20 years representing the IVD industry in 2012
Why IVD’s are key to the future of
healthcare
IVD’s - the tests and associated instrumentation
which helps to deliver them differ from medical
devices in that they are not products used but
products which deliver information – 70% of the
information used in treating patients comes from
IVDs.
Relatively young industry ~ 45yrs
Prior to that most tests were discovered and
produced in a hospital laboratory setting – leaving
the legacy of home brew or in-house tests
Diagnostics; making a difference
Could arbitrarily divide IVDs into sub-sectors:
Primary care – self tests and point of care
Secondary / Tertiary care – laboratory and point
of care
Diagnostics; making a difference
By values of the information the test provides as
• Non-specific tests which provide information at a
similar level to BP or taking a temperature
Eg The U’s & E’s, LFT’s and FBC we here on TV medical
dramas
• Tests which significantly change a patient’s
treatment, clinical pathway and/or outcome
Eg Calprotectin reducing referral for colonoscopy;
cardiac markers at point of care for traiage of chest
pain
Diagnostics; making a difference
Now and in the future:
Self testing and monitoring to manage long term
chronic disease in the community – role in digital and
telemedicine
More biomarkers to identify disease early – prevention
and early detection, stratification of patients,
reducing need for costly intervention
Companion diagnostics/personalised medicine/
theranostics/precision medicine
‘Although the past several decades have been
remarkable for the introduction of new
medical therapies, the
upcoming
years may well be known as
the age of diagnostics’
Janet Woodcock, Director of the Center for
Drug Evaluation and Research at the FDA
Woodcock, J. Assessing the clinical utility of diagnostics used in drug therapy. Clin Pharmacol Ther 2010. 88,
765–773
New IVD Regulation
The IVD Medical Device Directive 98/79/EU
Came into force fully on 8 December 2003
It’s been overdue for a revision
Now being revised in parallel with medical devices
Difference – In Vitro Diagnostics were the third
directive in the ‘family’ of medical device directives
but being further separated although some common
‘horizontal’ issues
What are the significant issues for
IVDs?
Health warning – have only seen an unofficial draft of the IVD
Regulation
Industry concern re additional cost; lack of regulatory expertise in
CA’s, NB’s and within companies; elements that may be difficult for
IVD’s; as well as ….
MHRA have raised following points:
Companion diagnostics
In-house testing exemption
Conformity assessment of Class D devices
Scientific advice
In-House Testing aka Home Brew or Laboratory
Developed Tests
In-House Testing
Industry view – need to retain an exemption for
new tests or those for such small number of
patients commercially unviable
Where there are commercial alternatives is test
production the right use of NHS staff time and
resource? Quality and reliability of production?
Confusing issues: off-label use, use of research
use only kits
Classification
Previously based on a list system as defined at the point
in time when the IVDD was drafted
Low risk, moderate risk and high risk
Made it difficult to introduce new tests appropriately
New system based on GHTF and rules based into 4
classes A to D where A is lowest risk and D is highest
Will impact on cost of manufacture by increased
requirement for use of NB’s
Companion Diagnostics
Proposed EU definition
“Companion diagnostics means an IVD intended to
select patients with a previously diagnosed condition or
predisposition for eligibility of treatment with a specific
medicinal product”
EDMA have coined phrase – Diagnostics Dependent
drugs
Need to ensure any additional regulation is applied
only to these tests
Clinical Evidence
New requirement
IVDD largely concerned with technical performance of
product – sensitivity, specificity, reproducibility etc
Relied on user knowledge about whether it was
actually clinically required
Questions?
Contact info: [email protected] Tel 02079574633