Need for innovations in Diagnosing TB - IKP-GCTBC at ARI - for shaing
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Networking Meeting on Grand Challenges in TB Detection & Diagnostics
June 4, 2015, Pune
Need for Innovation in Diagnosing TB
Prabhakar Kulkarni Ph. D.
ReaMetrix India Pvt. Ltd.
Out-of-the box solutions required from technology enablement through crowd sourcing
to break the barriers to achieve a complete TB diagnostic regime
4th June 2015
Presentation a ARI, Pune
IKP-GC-TBC Networking Meeting
INFECTIOUS CURABLE CONTROLLED
and only if
properly DIAGNOSED
T U B E R C U LO S I S
To curb the epidemic, we will need to reach the missing TB patients, diagnose TB without long delays, and make sure they take the full course of anti-tuberculosis therapy.
Smear Microscopy Culture Molecular Test
133 years after the Mycobacterium tuberculosis was discovered and detectedThe gold standard methods remain same
< 50% SensitiveTakes 8 weeks with
>90 % sensitivity
Infrastructure and Investment Intensive
G e n e r a l l y E P T B t r e a t m e n t i s b a s e d o n e m p i r i c a l d e c i s i o n
New Innovations in the pipeline
Imaging
1. Flourobot – automatic TB screener2. TBDx – Applied Visual Science3. FISH Probe based Fluorescence Microscopy - ID-FISH Tech. Inc.4. ReaSLR CSM – ReaMetrix5. Micromanager – BD6. CAD 4 TB – Delf Imaging and Advinio
Molecular and DST
1. Rapid Colorimetric DST – Trek and NanoLogix2. Hand held or Benchtop PCR – AlereQ, Epistem and MolBio
Diagnostics3. Molecular DST - TruArray MDR-TB (Akkoni) INFINITIMTB
(AutoGenomics) B-SMART (Sequella)4. MDR / XDR TBDx - Xpert MTB/RIF ( Sensitivity), XDR (Cepheid)
Alere Q (Alere), Enigma ML (Enigmadiagnostics) Q-POC(QuantuMDx), DiagCORE (Stat-Diagnostica) EOSCAPE (Wave80)RT-PCR Testing Platform
5. LPA second-line (Hain) LPA first line followers (Nipro, YD)
Innovative1. LAM detection – Alere Inc, InBio Inc. Standard Diagnostics Corp.2. VOC – Apopo Rats, 3. Breath Analyzers – eNose, Rapid Biosensors, etc.
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In search of Better, Reliable and Affordable TB diagnostic solutions
Why do we always need more ?
1. Triage test for screening TB patients,2. Detection Test for confirmation of MTB infection,3. One TB test for all EPTB suspects4. Drug Susceptibility test to identify MRD TB cases5. Follow up test for treatment monitoring,
A Reliable, Affordable, Accessible Diagnostic test which provides MTB specificinformation within minutes to hours is the most urgent need for TB control
RapidReliableAffordable
&Accessible
PATIENTCan still be with his children because of reliable diagnosis and
early initiation of treatment
FAMILY MEMBERCan comfort the loved one without putting everyone in the family at risk
HEALTH CARE WORKERCan work without fear of professional hazard
4th June 2015 7
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Need for
Innovative TB Screening and Confirmation Test
Reliable – Sensitive & SpecificAffordable & Accessible
How can we solve the problem ?Key: framing the problem
Looking for inspirations from the following:
1. Engineering and Design Solution for bringing the transformation
2. Leveraging the Understandings from Modern Biology
Screening Test
TRIAGE TEST• Dipstick Assay• TB & non-TB • EPTB
INSTRUMENTS• Breath Analyzers• Digital X-Ray read out
SPUTUM INDUCTION• TB-HIV patients• Geriatric and Pediatric
patients
IT SOLUTION• Apps for cough pattern
analysis and prompting tool for tests
Detection Test
DETECTION SYSTEMS• Testing in ambient air
REAGENTS & CONSUMABLES• Cold-chain free bio-safe
sample transportation• Bio-safe Sample Collection
.
Diagnostic Test
POC Test• Rapid POC test in the field• POC test for resource
constrained setting
TREATMENT MONITORING• Test for patient follow up
POPOULATION SPECIFIC Test• Correlate genotype with
phenotype.
BENCH TOP Test• Without bio-safe
infrastructure
DST Test• Universal DST for field• Rapid DST• DST for new drugs
4th June 201511
• ReaMetrix India Pvt. Ltd. And ReaMetrix Inc.
work together to develop affordable new
diagnostic tools
• A next generation biotechnology company
• Use the challenge of developing innovative
affordable solutions as a driver to break the
rules of conventional thinking.
• Committed to conceive, create and validate
solutions at the local user environment, so as
to impact the entire innovation process.
• Address the emerging needs of the developing
world and have a paradigm changing impacton global healthcare delivery.
Accelerated Innovations for Affordable Diagnostics
TB Diagnostics Program in ReaMetrix
ReaMetrix’s Approach to IVD
Total Systems Approach for Disease Management4th June 2015 12
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In Clinical Microbiology
SEEING is BELIVING
Microscopy and Culture might remain as the first line diagnostic tools
Why not improve the existing methodswithout disrupting the economics and infrastructure
Why do we focus on SPUTUM based Test ?Key: framing the problem
SPUTUM is the Carrier Of Mycobacterium tuberculosis
Early and Reliable detection of TB in sputum is the key to success to control the spread of the disease which is global public health care issue
Zero tolerance for FALSE NEGATIVE results
Hence , we have developed ReaSLR CSM for concentrated sputum smear microscopy
Why can’t we improve what we have ?
Innovating to solve the real world challenges
to provide better results with existing test
Sputum Sample Processing
Staining Reagent
ReaSLR Sputum Liquefaction Reagent for;
1. Liquefaction2. Decontamination3. Inactivation of MTB (optional)4. Staining
All in SINGLE step
• ReaSpark – for LED-FM• ReaBrite - for Bright Field
Microscopy• ReaGlow – Live/Dead staining on
IMMEDIA
Room temperature stable, phenol-free reagent for cold staining protocol
Room temperature stable, Unitized Reagent
Dreaming of a Paradigm Shift
Innovating to bring new ways of diagnosing TB
ReaSLR CSM ReaTBDx
For Live/Dead MTB enumeration on IMMEDIA
For Concentrated Smear MicroscopyOn LED-FM
1. One step Liquefaction, Decontamination, Staining and Concentration of MTB cells
2. Detection using Fluorescence Microscopy
3. Higher Sensitivity and Ease of use
1. Enumeration of Live/Dead MTB using specific Antibodies
2. Essential to follow-up treatment
3. Useful in DST analysis
Design Approach to solve the problems“Small changes can make big difference”
1. Sputum Processing Cup – with graduationmark : No need to measure the volume
2. Dropper Bottle – addition of reagents : Nopipetting required
3. Custom Made Magnetic Stand – Ease of use
4. Glass Slides with Fluorescent Grids – Ease ofdetection
5. Microfluidic Capillary – containment ofsample
6. Inbuilt Filter – to avoid debris
7. Reagent in Tablet form – ease of use
THANK YOU
www.reametrix.comenquiry@reametrix.com
prabhakar@reametrix.com
Contact us for orders, product evaluation and collaborations
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