MDR TB Diagnostics Kampala, 22 Oct 2012 Ajay Thirumala

Our strategy Accelerate diagnostic innovation along a value chain: ISO 13485 certification for project management and clinical trials. (Focus: TB, Malaria and HAT) Leverage investment against preferential prices for low and middle income countries. (Affordable) Strengthen Local Laboratory facilities to ensure new technologies are Accessible to everyone (Focus: Public Health Facilities). Produce Development Partnership: Build and sustain effective partnerships- currently 200 active partners in 61 countries.

The impact of diagnostics Tuberculosis The slow path to diagnosis for patients with cough: Grzybowski, et al. Bull Int Un Tuberc 1975;50:90 Reduced disease transmission Effective disease control, including DRTB Decreased morbidity/mortality Credible health system More and more slow path: Drug resistant TB detection and treatment

Key advancements in the diagnostics - FIND’s role 2007 2008 2009 2010 2011 Liquid culture; rapid speciation Line probe assay LED-based fluorescence microscopy Automated NAAT (Xpert MTB/RIF) TB Implementation of WHO endorsed tests and capacity building Round 2 Round 1 Round 3 RDT product testing Blood transfer device Malaria Implementation support (training, job-aids, SMS reporting) LED-based fluorescence microscopy Rapid screening test prototype developed HAT / OND mAECT production in DRC

Pipeline for New Diagnostics for TB and MDR-TB, July 2012

Drug resistant TB MDR-TB*: Uganda Multidrug resistance- MDR TB Isoniazid and Rifampicin Extensively drug-resistance- XDR MDR + fluoroquinolones and at least one of injectables: amikacin, capreomycin or kanamycin MDR-TB*: Uganda

Expandx TB Project Overall grant (GLI, GDF, FIND): 90.5 Mio (incl. 2 Mio for Xp) Funding for FIND: 21.2 Mio (including 1.5 Mio OGAC) Duration: Dec 2008 - Dec 2013 Project goal: Expand access to MDR-TB dx in 27 countries Key deliverables: Identify 129,000 MDR cases; Impact market dynamics (price, # suppliers) Progress: MOUs with 22/27 countries Initial assessments for 24/27 countries >10,000 MDR-TB patients diagnosed by end 2011

Expandx TB Uganda 2010- July: MOU with Min. of Health, Uganda 2010- July: 1st Lab Assessment – GLI-FIND combined 2010- Sep/Oct: Civil work initiated at Mulago Referral Hospital for point-of-care MDR-TB lab 2011- May: New diagnostic equipment installation at the Lab 2011 July-Sep- Standardization of technology, trainings and orientations to staff 2011 Nov- Lab started testing for patients; and is provided 5 start SLAMTA accreditation as part of NTRL

Civil works - Ward 5&6-Mulago Hospital, NTRL, Kampala, UGANDA Main entrance Ramp

Equipment installation The Republic of Uganda MINISTRY OF HEALTH Equipment installation

Tuberculosis Rapid Diagnostics Lab at Mulago The Republic of Uganda MINISTRY OF HEALTH Tuberculosis Rapid Diagnostics Lab at Mulago Lab showing air-extraction ducts

Entry door for containment room Anteroom entry to containment room Entry door for containment room View of containment room from anteroom

The Republic of Uganda MINISTRY OF HEALTH Containment room

Pre-amp room view Heating block for DNA extraction Microfuge-DNA extraction Pre-amp room view

Hands on trainings for LPA

Year MDR* All Susceptible Total** 2010 37 228 312 2011 49 489 655 2012 Line Probe Assay (LPA) for detection of MDR-TB NTRL, Uganda (15th Mar 2010-18th Oct 2012)  Year MDR* All Susceptible Total** 2010 37 228 312 2011 49 489 655 2012 83 360 551 Total 169 1077 1518 *- MDR- Patients showing resistance to both Isoniazid and Rifampicin **- Includes other than MDR drug resistant patients

GeneXpert (Xpert MTB/RIF) for Diagnosis of TB and rifampicin resistant TB - Two hours cartridge based test. Automated Possible at district level. Peripheral Lab and clinical staff can run it Can detect Smear negative TB- problem of HIV patients Challenge in POC facilities-Electricity?

Local innovations: GeneXpert works with Solar power- Luwero HC IV Capacity: 3 Gx-4 runs/ day Expected sun-hours: 1800-2000/year Started in: April 2011 Approx Cost: 3600 USD Early Evidence for scale up Grant: Dutch Government FIND March-2011 Details of Mfg: Solar Panels: Dulas Solar (http://www.dulas.org.uk/index.cfm) Solar Charge Controller: Tarom, Steca GmbH (http://www.stecasolar.com/index.php?Steca_Tarom_en) Inverter: Local Kampala market- Chinese make Solar batteries: Local Kampala market- Luminous India make Technician: Local Kampala school pass-out

Grant: TB reach Wv2, STOP TB Partnership (0.6 million USD) Early scale-up of Xpert for TB in HIV positive patients at six sites under NTLP

Results of Xpert roll-out in Uganda (Nov 2011 -June 2012) Xpert site TB Negative MTB positive very Low MTB positive Low MTB positive Medium MTB positive High TOTAL TASO, Entebbe 527 42 24 14 4 631 Fort Portal RRH 585 56 46 7 770 Jinja RRH 339 19 13 2 421 Lira RRH 547 62 27 3 738 Masaka RRH 392 34 16 539 Soroti RRH 509 60 23 703 2899 273 180 117 26 3802 *3 rifampicin resistance cases out 596 TB cases: two confirmed at NTRL, and one died

National TB & Leprosy Program Thank You National TB & Leprosy Program MOH, Uganda 23

Bunyaazi Island Around 30 nautical miles south of Entebbe Client visit : beneficiary of FIND-TBR Wv 2 project –Xpert MTB/RIF test Visit 20-June-2012 (FIND, NTRL (MoH), TASO) Bunyaazi Island Around 30 nautical miles south of Entebbe UGANDA Entebbe Lake Victoria Bunyaazi