Mobile Lab-Diagnostik

Mobile Lab-Diagnostik
Jenaer Technologietag 2013
Alere Technologies GmbH, Jena; 11.11.2013, Torsten Schulz
ALERE TECHNOLOGIES
Alere Technologies GmbH
former CLONDIAG GmbH
1998/1999 Foundation;
2001 first OEM business with own products (ArrayTube)
(2002 Building OEM Manufacturing for IVD Products)
2006 Joining Inverness Medical Innovations (Alere Inc.) starting PIMA Project
& HIV-NAT-POC Project
2009 Launching PIMA CD4
4000 Instruments are in the field, production capacity 5 Mill / a
320 employees ~ 170 R&D; ~ 110 Operational business
2013 Launche of Alere q (IUO)  HIV-NAT-POC
One of the main locations for R&D @ Alere
About Alere Inc.
Waltham Massachusetts
http://www.alere.com
World market leader in POC diagnostics
Revenue 2012
Profit
Employees worldwide over
2.4 B $
1.25 B $
>12.000;
1000 sales and marketing; 500 R&D
Fields of activities:
•Consumer diagnostic
•Professional diagnostic
•cardiology, womens health, infectious disease, oncology and toxicology
•Health care management:disease management program, patient self-testing
services, womens and childrens health, oncology programs
Selling points and manufacturing sites all over the world
Mobile Lab Diagnostik am Beispiel
NAAT POC
 Alere q Platform:
 HIV NAAT – POC Diagonstik:
Alere q Vollblut & Plasma
 TB NAAT POC Diagnostik
 TB-Resistenz NAAT POC Diagnositk
HIER STEHT DER DISCLAIMER
4
Challenges of HIV Diagnosis and Treatment
Challenges of TB Diagnosis and Treatment
Estimated 8,8 million new cases (2010) and 1,5 million associated deaths
CONFIDENTIAL, ALERE INC.
7
Microscopy Center Conditions
Ziehl-Neelsen
CONFIDENTIAL, ALERE INC.
8
Field Experience from CD4 Testing
Alere Pima CD4
CONFIDENTIAL, ALERE INC.
9
Alere Q Platform
CONFIDENTIAL, ALERE INC.
10
Alere Q HIV-1/2 Sample Collection
CONFIDENTIAL, ALERE INC.
11
Alere Q HIV 1/2 VL Test
Intended Test Use
Test for Diagnosis of HIV Infection and
Monitoring of Viral Load in HIV+ patients
Goal of Test
Detection of HIV-1 AND/OR HIV-2 RNA in
whole blood OR EDTA plasma; fully
quantitative viral load measurement of
HIV-1 M, N
HIV-1 O and
HIV-2
LOD 100cp / test
Anaylyzer
Instrument
Portable device; app 5kg weight; no
maintenance or calibration required
Quantitation
Quantitative; HIV-1 and HIV-2 separately
reported
Precision
0.3 log
Sample Specimen
25 µL of finger prick blood (25µL) or EDTA
plasma
# steps required to Test does not require any sample handling or
run the test
pre-treatment by user
CONFIDENTIAL, ALERE INC.
12
Introduction to Alere q
lyse whole blood in the presence of capture
molecules with anchor groups
Complex of HIV nucleic acids and capture probes
with anchor groups is formed (hybridization)
Capture complex onto solid matrix (via anchor
groups)
Remove all unbound material (nucleic acids,
proteins, low molecular weight contaminants etc.
amplify captured nucleic acids and
quantitatively detect the formation of amplified
nucleic acids by quantitative real time reporter
hybridization PCR
13
The cartridge
HIER STEHT DER DISCLAIMER
14
The cartridge design
Capillary
containing
EDTA
cap
Venting
Septum
Washing buffer
chamber
PR-TRT
Pellet
chamber
Lysis &
IPC &
capture oligos
Wash Buffer Reservoir
Alere Technologies Jena
NAAT Reactor
chamber
with detection
chip and capture
beads
valve
chanels
Page 15
Sputum Sample Collection
CONFIDENTIAL, ALERE INC.
17
TB cartridge
NEAR-NAAT
HIER STEHT DER DISCLAIMER
18
Alere Q Modifications for Large Volume Cartridges
CONFIDENTIAL, ALERE INC.
19
Sputum Sample Cup and Cap
CONFIDENTIAL, ALERE INC.
21
Sputum Sample Cup and Cap
Threaded screw cap
CONFIDENTIAL, ALERE INC.
22
Sputum Sample Cup and Cap
Red line disappears
when fully closed
CONFIDENTIAL, ALERE INC.
23
Sputum Collection Cup and Cartridge
Slide sample cup onto cartridge
until it click-locks in place
CONFIDENTIAL, ALERE INC.
25
Inserting Complete Cartridge into Q instrument
CONFIDENTIAL, ALERE INC.
26
Fully-Automated Workflow for TB Diagnosis
CONFIDENTIAL, ALERE INC.
27
Fully-Automated Workflow for TB Diagnosis
1. Sputum liquefaction, homogenization an filtration
CONFIDENTIAL, ALERE INC.
28
Fully-Automated Workflow for TB Diagnosis
2. Nucleic acid purification and mycobacterial DNA enrichment
CONFIDENTIAL, ALERE INC.
29
Fully-Automated Workflow for TB Diagnosis
3. Reagent reformulation and NEAR reaction setup
- Filtration
-washing
- Lyse
-buffer setup
CONFIDENTIAL, ALERE INC.
30
Fully-Automated Workflow for TB Diagnosis
4. NEAR isothermal amplification
CONFIDENTIAL, ALERE INC.
31
Fully-Automated Workflow for TB Diagnosis
5. Real-time fluorescence signal detection
CONFIDENTIAL, ALERE INC.
32
Results and Connectivity Options
Touchscreen
Printer
USB ports
Ethernet port
GPRS Modem
CONFIDENTIAL, ALERE INC.
34
TB Drug Resistance Testing Strategy
 Separate reflex cartridges matched to the clinical utility of the drug resistance
information and location of therapy
TB diagnosis on TB suspects
First-line drug resistance testing on TB patients
Second-line drug resistance testing on MDR-TB patients
 Uses same cartridge with fully automated sample prep
Works with sputum or cell culture
 PCR amplification and CMA (competitor monitor amplification) detection ideal for
multiplex SNP’s
 Developing model system that can be adapted to different SNP’s depending on TB
drug therapy clinical trial outcomes
CONFIDENTIAL, ALERE INC.
36
TB Drug Resistance Test Cartridge
 Multiplex amplification with CMA (competitor monitor amplification)
detection integrated into cartridge
 Hybridization pattern converted into quantitative output
 Resistance information derived by applying test-specific algorithms
 Integrated controls for high specificity and failure mode analysis
ALERE INC.
 CONFIDENTIAL,
Total analysis
time approx. 30-45 min
37
Kontakt
Vielen Dank!
Dr. Torsten Schulz
Alere Technolgies GmbH
Löbstedter Str. 103-105
D-07749 Jena
38