1. 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

2. 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

3. 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

4. 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

5. 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

6. ‘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

7. 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

8. 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

9. In-House Testing aka Home Brew or Laboratory Developed Tests

10. 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

11. 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

12. 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

13. 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

14. Questions? Contact info: doris-ann@bivda.co.uk Tel 02079574633doris-ann@bivda.co.uk