Need for innovations in Diagnosing TB - IKP-GCTBC at ARI - for shaing

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

8

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

[email protected]

[email protected]

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