Diagnostic kit for Entamoeba histolytica

infections ENTAMOEBA HISTOLYTICA Entamoeba histolytica (E. histolytica) is a protozoan parasite that is the causative agent of extraintestinal amoebiasis, which manifests as amoebic liver abscess (ALA). E. histolytica causes high rates of morbidity and mortality in people especially in developing countries. For example, E. histolytica affects an estimated 480 million people annually; about 10 percent of these people develop colitis, ALA, or other symptoms. World Health Organization (WHO) reported that in 1997, amoebiasis was ranked second for causing the most number of deaths worldwide compared to any other parasitic diseases. In 2005, a study performed in Malaysia indicated that about 72.4% of the 58 liver abscess cases admitted at Hospital Universiti Sains Malaysia (HUSM) over three years were diagnosed as ALA using antibody detection test. In 2009, using a DNA-based technique, 76.7% of 30 liver abscess cases in HUSM were found to be positive for E. histolytica DNA in pus from liver aspirate samples. In order to prevent complications that result from ALA, accurate and early diagnosis of ALA is important. Nevertheless, diagnosis of E. histolytica is often difficult. Amoebic dysentery caused by E. histolytica is easily confused with monocytic erythrophagocytosis and erythrophagocytosis caused by Entamoeba coli. Antibody detection is a current method used to detect antibodies of E. histolytica in serum samples. However, this method may only be useful in nonendemic areas as the currently available commercial tests use a complex mixture of native E. histolytica proteins and often cannot differentiate current and past infection when used in endemic areas. Although DNA-based techniques such as real-time PCR has been utilised to detect E. histolytica DNA in pus aspirates with high sensitivity and specificity, the cost to perform this technique is quite high and can only be performed in reference laboratories where specialised equipment and trained personnel are available. Further, pus aspiration is an invasive procedure, and not suitable to be performed for all suspected patients. Another diagnostic method involves detection of a lectin found on the surface of E. histolytica and E. dispar trophozoites. However, this detection method is unable to distinguish between pathogenic and non-pathogenic strains. The present study have come out with a method of detecting E. histolytica infection in a clinical setting, which detect at least one E. histolytica protein, fragment, variant or mutant and/or antibody that specifically binds to the E. histolytica in a serum sample. This method offers high sensitivity and reliability.

• Use recombinant an t igens and can be p roduced in a s tandard ised and reproduc ib le manner

• Po in t -o f care tes t (POC) • Rap id resu l ts (about 15 – 20 m inu tes) • H igh sens i t i v i ty and spec i f i c i ty • Versa t i le , sma l l and compact , easy to use • Easy to in te rp re t resu l ts v isua l ly and no spec ia l ised equ ipment is needed • Cos t e f fec t ive • Can be packaged in to vary ing quant i t ies to su i t the marke t demands fo r

d i f fe ren t se t t ings • S tab le fo r 18 months • Do no t need co ld cond i t ion fo r t ranspor ta t ion , wh ich is impor tan t fo r ru ra l

a reas • Sample can be serum, p lasma or who le b lood

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WHAT’S NEXT?

The inventors would like to speak to companies interested in licensing the technology.

E: info@platcomventures.com T: +603 8319 3116

CONTACT

THE INNOVATION

This method offers sensitive and reliable diagnosis and treatment of Entamoeba histolytica infections. The dreaded protozoan parasite causes the extraintestinal amoebiasis disease that finds its way into the liver. Statistics show that the amoebiasis was ranked second as causing the most number of deaths worldwide, compared to any parasitic diseases. The high costs and inability of many diagnostic methods make this cost effective invention possible to detect E. histolytica. Its market opportunities are in global and regional perspectives, due to its low prevalence of the infection in Malaysia.

COMPETITIVE ADVANTAGES

The marke t oppor tun i ty is no t in Ma lays ia . There is a low preva lence o f E. h is to ly t ica in fec t ion in th is count ry , thus i t a lso has a l im i ted v iab i l i t y fo r the domest ic marke t . However , there is p romis ing marke t oppor tun i t ies in the g loba l and reg iona l perspec t ives . E. h is to ly t ica in fec t ions a re s t i l l an impor tan t hea l th p rob lems in o ther t rop ica l and sub t rop ica l coun t r ies inc lud ing :

• Mex ico • South Amer ica (Braz i l , Co lumbia , Venezue la ) • South As ia ( Ind ia , Pak is tan , Bang ladesh) • South Eas t As ia (Tha i land , V ie tnam, Ph i l ipp ines) • Eas te rn and Southern A f r ica

The cur ren t inven t ion is app l icab le to : • Hosp i ta ls – government and p r iva te • Government c l in ics and hea l th cen t res • Pr iva te labora to r ies (Pa th lab , BP lab , e tc ) • Genera l p rac t i t ioners

MARKET POTENTIAL

© 2014 PlaTCOM Ventures. All rights reserved.

Diagnosis of Entamoeba histolytica has been protected via the filing of Malaysia patent and PCT.

INTELLECTUAL PROPERTY

Joint manifestations for patients of Chi

PROJECT  CODE:  P378