CE2012 – Thursday 20 September

The In Vitro Diagnostics View

Doris-Ann WilliamsChief 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 ~ 45yrsPrior 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 differenceCould 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 differenceBy values of the information the test provides as• Non-specific tests which provide information at a

similar level to BP or taking a temperatureEg 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 differenceNow 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/EUCame into force fully on 8 December 2003It’s been overdue for a revisionNow being revised in parallel with medical devicesDifference – 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 diagnosticsIn-house testing exemptionConformity assessment of Class D devicesScientific advice

In-House Testing aka Home Brew or Laboratory Developed Tests

In-House TestingIndustry view – need to retain an exemption for new tests or those for such small number of patients commercially unviableWhere 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 draftedLow risk, moderate risk and high riskMade it difficult to introduce new tests appropriatelyNew 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 drugsNeed to ensure any additional regulation is applied only to these tests

Clinical Evidence

New requirementIVDD 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: doris-ann@bivda.co.uk Tel 02079574633