Using LDTs to streamline CDx development. Dr Bob Holt Companion Diagnostic Development Manager

Transcription

1 Using LDTs to streamline CDx development Dr Bob Holt Companion Diagnostic Development Manager

2 Disclaimer This presentation contains my personal views and research and does not necessarily reflect the policies or endorsement of Hologic Inc. This presentation contains forward-looking information that involves risks and uncertainties, including statements that are based upon assumptions made by market research which are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those anticipated.

3 Hologic Overview

4 A world leading healthcare company 5,000+ employees worldwide $2.8B+ in revenues in fiscal 2016 Commercial operations around the world Diagnostic Solutions Breast & Skeletal Health Solutions GYN Surgical Solutions

5 Hologic as the Partner of Choice Proven Track Record 100+ FDA approved/cleared products First FDA-cleared DNA test 350+ patents Global Presence Offices in 17 countries Three ISO13485 certified manufacturing facilities 92M+ molecular tests produced annually Products sold in over 100 countries Panther instrument placements Hologic Panther molecular systems installed globally.

6 Hologic as the Partner of Choice Market Leading Products Diagnostic Solutions Imaging/Breast Health Surgical Proprietary Chemistries TMA and Real Time TMA: Multiple FDA and CE Dx tests High levels of specificity Invader and InvaderPLUS : Isothermal DNA probe based - multiple FDA and CE Dx tests Automatable and scalable Flexible assay design compared to e.g. TaqMan All market shares are Hologic estimates for the US market on a unit basis in 2014.

7 20 Years of ThinPrep ThinPrep Pap Test is a liquid-based pap test that preserves cells and nucleic acids 650 million+ ThinPrep Pap tests have been performed ThinPrep test is also FDA approved for a wide range of additional assays: APTIMA HPV Assay APTIMA HPV 16, 18/45 Genotype Assay Cervista HPV HR Cervista HPV 16/18 Roche cobas HPV Test Roche cobas AMPLICOR CT/NG Digene hc2 FDA cleared additional assays: APTIMA Combo 2 Assay (CT/NG) APTIMA Trichomonas Assay BD ProbeTec Chlamydia trachomatis (CT) BD ProbeTec Neisseria gonorrhoeae (GC)

8 20 Years of Personalised Medicine

9 The Panther System

10 Fully Automated From Sample To Result Amplification & Detection Results Analysis Extraction Sample Preparation

11 Menu Consolidate Testing onto a Single Platform CT/NG CT NG TV M. gen HSV 1 & 2 HIV-1 Quant Dx HCV Quant Dx HBV Quant HPV HPV GT 16 18/45 Run four assays simultaneously

12 The Biomarker Paradox

13 Drug Development and the Biomarker Paradox CDx Investment Phase I Phase II Phase III No efficacy data before Phase II 2/3 fail IUO development timelines months CDx investment required before efficacy is proven Pharma need to move to Phase III quickly Compresses timelines for Diagnostic partner Drug Efficacy IUO Assay

14 Co-Development Options FDA draft guidance on Principles for Co-development of an In Vitro Companion Diagnostic Device with a Therapeutic Product FDA recommends the IVD is analytically validated prior to use in clinical trials Also describes several different clinical trial designs and validation routes Prospective-Retrospective - A prospectively defined retrospective analysis of trial outcomes according to the test result IVD Bridging studies using Clinical Trial Assays ( LDT) FDA recognizes there may be circumstances that prevent this (contemporaneous marketing authorizations). FDA will resolve each situation on a case-by-case basis A locked down IUO assay is not always needed at the start of Phase III

15 Drug Development and the Biomarker Paradox Phase I Phase II Phase III Option 1 LDT Investment CDx Investment Option 2 LDT Investment CDx Investment Quick transition from LDT to IUO requires an IVD ready platform with LDT capabilities

16 The Next Evolution of The Panther System

17 The Panther Fusion * System The Panther System Proven Flexibility and Efficiency The Panther Fusion System * Expanded Flexibility and Scalability Design Goals: Universal nucleic acid capture and PCR Ready to use reagents with 60 days on-board stability Run up to 32 assays simultaneously Open channel capability for Lab Developed Tests (LDTs) Field upgrade to existing Panther system *Panther Fusion is under development and not currently for sale.

18 Panther Fusion* is an Extension of Panther Fusion Module Panther Fluid Drawer Tip Drawers Reaction Vials/Caps MTU and Reagent Cartridge Level Reagent Cartridge Loading Drawer Waste Drawer 7 Position Capture Reagent Carousel 60 cm 121 cm *Panther Fusion is under development and not currently for sale.

19 Expand Menu Capabilities Ready to use reagent cartridge format 12 individual, unitized tests in each cartridge Up to 28 test cartridges and 4 TMA assays on board Fluids and assays stable on-board for up to 60 days Four assays per extraction High-multiplex options Modular panels or combined for broad panel Open channel capabilities for in-house tests Fully automate in house testing Run LDTs simultaneously with IVD assays Panther Fusion is under development and not currently for sale.

20 The Panther Fusion* System Expands Test Menu Current CE-IVD Assays CT/NG, CT, NG TV M. gen HSV 1 & 2 HIV-1 Quant Dx HCV Quant Dx HBV Quant HPV HPV GT 16 18/45 Currently in Development CMV Influenza A/B/RSV Parainfluenza 1-4 AdV/hMPV/RV C. diff MRSA Open Channel Zika virus Future Development Enteric pathogens Infectious diseases Respiratory pathogens Panther Aptima Assays Panther Fusion Assays * Panther Fusion is under development and not currently for sale.

21 Hologic Building Innovation Panther Fusion is under development and not currently for sale.

22 The Panther Fusion* System for CDx *Panther Fusion is under development and not currently for sale.

23 LDT Protocol Creation and Validation Workflow 2. Protocol is unlocked during optimization 1. User creates protocol with LDT software 5. User defines thresholds, cutoffs, etc. and locks completed LDT protocol ABCB1 CYP2C19 FADS1 KIT SLCO1B1 ABCB11 CYP2C8 FGFR1 KRAS STK11 ABCG2 CYP2C9 FMO3 LEP TM6SF2 ABL1 CYP2D6 GSTM1 MTRR TMC4 ANGPT2 CYP3A4 HFE NR1I2 TNF APOE CYP3A5 HGF NRAS TNFRSF1B BRAF EGFR IGF2 OPRM1 TP53 CD74 ERCC1 IL6 PDGFRA UGT1A1 CFH ERCC3 JAK2 PIK3CA VEGFA 3. Run LDT on Fusion 4. Results evaluated Panther Fusion is under development and not currently for sale.

24 Smooth Transition from LDT to CDx Phase I Phase II Phase III LDT Investment CDx Investment Same Instrument Same Reagents Same Software Panther Fusion is under development and not currently for sale.

25 Summary LDTs can be used to streamline CDx development Efficient transition to IVD requires an IVD ready instrument, reagents and software Early FDA interactions are key Allows CDx investment to be made once efficacy is established See the new Panther Fusion* System in action Talk to us about LDT development ready-to-run on Panther Fusion* system Hear more about our CDx Services *Panther Fusion is under development and not currently for sale.

26 Thank you! Hologic, Inc. All rights reserved. Hologic, The Science of Sure, Aptima, Invader, InvaderPlus, Panther, Panther Fusion, ThinPrep, Tigris, Tomcat and associated logos are trademarks or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. This information is intended for medical professionals and is not intended as a product solicitation or promotion where such activities are prohibited. Because Hologic materials are distributed through websites, ebroadcasts and tradeshows, it is not always possible to control where such materials appear. For specific information on what products are available for sale in a particular country, please contact your local Hologic representative or write to pharma@hologic.com. Panther Fusion is under development and not currently for sale.