Presentation on theme: "FROM RESEARCH TO INDUSTRY: MOLECULAR DIAGNOSTICS IN SRI LANKA"— Presentation transcript:
1FROM RESEARCH TO INDUSTRY: MOLECULAR DIAGNOSTICS IN SRI LANKA MAYA B. GUNASEKERA, PH.D.GENETECHMOLECULAR DIAGNOSTICS & SCHOOL OF GENE TECHNOLOGY , COLOMBO 8
2Background of Research … Research in Molecular Biology – Initiated at Department of Biochemistry and Molecular Biology, Faculty of Medicine, University of Colombo 1991First Ph.D. project - funded by NSF and TWAS,Italy.Biotechnology Laboratory, Faculty of Science,University of Colombo established in throughJICA grant.3 Ph.D. projects initiated - One funded by IFSSweden (1995) and two funded by the NSF (1996 and 1997).IAEA funded collaborative project initiated (1999)Total research funds received through these projects ( ) - USD 70,000
3Research OutputNumber of Ph.D. thesis – 4Development of DNA probes for An. culicifacies complex,Population genetic study of the Asian elephant in Sri Lanka,Development of DNA markers for the identification of humans inSri Lanka - this project led to the use of DNA typing for casework in Sri LankaMolecular systematics of a fruit bat species complexIAEA project on dengue led to the establishment of a molecular diagnostic assay for dengue in Sri LankaAwards – TWAS/NSF Young Scientist Award, IFS, Sweden Jubilee Award, Post graduate Research Publication Award, President’s Research Award, University of Colombo Award for Excellence in Research , NSF Merit Award, Second best paper in an International Conference.
4Genetech – the first private biotech institute… Inauguration was held in 2003Scientists3 Post doctoral (one visiting)1 M.D. , M.Sc.1 M.Sc.5 B.Sc. graduatesTotal no. of employees – 16Our mission – Is to make the benefits of biotechnology accessible to wider public in Sri Lanka
5Genetech Services Molecular diagnostic services for infectious and genetic diseases.DNA profiling services to the public, includingcivil and criminal caseworkGM food testing - latest additionTraining courses in gene technology todisseminate knowledge / to develop skillsrelated to biotechnology fieldIt is indeed with great pride that I demonstrate to you the molecular diagnostic facilities at Genetech. My intention here is not to give you technical details of our diagnostic facilities but to make you understand the principle behind our technology as we believe that then you would appreciate the technology but also get the maximum benefit of such technology.
6Laboratory Diagnosis of disease – Traditional methods Culture and Microscopy – morphological characteristicsAnalysis of host and pathogen enzymesImmunochemical tests (IFAT, HI, and ELISA)Analysis of antibodies – indirect testAnalysis of antigens of pathogens –direct testAll these methods are based on the detection of gene products.
7Nucleic acid-based diagnostics All biochemical and physical differences can be traced back to differences in the genetic material.Universal chemical and universal methods.Detects the organisms rather than gene products of organism and host antibodiesHigher sensitivity – minute number of organisms present in a clinical sample can be detected due to the ability to amplify the DNA (by Polymerase Chain Reaction- PCR) found in a specimen.Higher specificity and accuracy.High throughput- large number of samples can be processed together.Rapid screening of one sample for several organisms.
8Diagnosis of Infectious Diseases Each organism has unique DNA regions - such regions have been cloned and DNA sequenced.Primers have been designed to specifically amplify such regions by PCR if the organism is present in a clinical specimen.A million of copies of a DNA region unique to the pathogenPCR Product
9Detection of TBM S1 S2 S3 S4 WE DW +Ve123 bp target product
26DNA typing services… Positive identification of criminals Rape/ sexual abuseMurderChild AbuseIncestTheftPositive identification of criminalsExoneration of innocent suspectsChild maintenanc CustodyAdulteryInheritanceImmigrationEstablishment of paternity/family relationshipsMutilated/decomposed bodiesEstablishment of identity
30Limitations of DNA-based diagnostics Need special equipment, expensive chemicals and highly skilled staffAccuracy and reproducibility depends on the technical experience of the operatorFalse negatives may arise due to PCR inhibition and false positives may arise due to PCR contamination. Therefore stringent quality control measures must be taken by the PCR Laboratory.
31Genetech services – Quality guaranteed…. In-house PCR-based kits prepared based on published protocolsValidated with commercial kits/ with positive clinical specimens with each newly prepared reagentsAll steps are subjected to well documented quality control and quality assurance proceduresAll tests performed by trained, qualified staffPre & Post PCR physically separatedUse of Filter tips, separate pipettes and PCR hoods, negative controls with each assay – no short-cutsCheapest in the world.
32Genetech Training Courses…. Training under the Ministry of Science & Technology Personnel Development project sponsored by ADB –18 personnel from the university sector.Other Genetech courses – 184 persons trainedSchool children and undergraduates -lectures and demonstrations – > 1000In-house Training of Police Officers in handling and collection of DNA evidence – 2054 hr training scheme for more than Police Officers