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The Changing Landscape of MDx

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MDxA genetic screening test is a promising area for future expansion of in vitro molecular diagnostic market, says Nitin Sawant, General Manager – Diagnostic, Trivitron Healthcare Pvt. Ltd.

How do you perceive the Indian Molecular Diagnostics market? What are the drivers that are influencing this segment in India?

Molecular diagnostics (MDx) is the fastest-growing segment of the Indian in vitro diagnostics industry. The interest in molecular diagnostics has been boosted by the current fears of emerging infectious diseases, and the genes and molecular markers derived by genomics and proteomics. Initial applications of molecular diagnostics were mostly for infections but are now increasing in the areas of genetic disorders, preimplantation screening and cancer. Detection of specific chromosomal translocations has both diagnostic and prognostic value in a variety of childhood cancers. A genetic screening test is a promising area for future expansion of in vitro molecular diagnostic market. Molecular diagnostics is being combined with therapeutics and forms an important component of integrated healthcare. Molecular diagnostic technologies are also involved in development of personalised medicine based on pharmacogenetics and pharmacogenomics.

Blood banking has been the most dynamic testing segment to adopt molecular diagnostics approaches since their introduction. Screening for HIV, HCV and HBV in donated blood, plasma and organs has largely been done by immunoassay procedures. In conjunction with background screening, this has become a very effective approach toward guaranteeing the safety of the blood/organ supply.

Nitin Sawat General Manager - Diagnostic, Trivitron Healthcare Pvt. Ltd.

Nitin Sawat
General Manager –
Diagnostic, Trivitron Healthcare Pvt. Ltd.

What types of Molecular Diagnostics instruments are growing or declining?

Recently the Real time PCR technology and instruments are becoming popular because of its ease of use, fast turnaround time, sensitivity and specificity. This technology gives qualitative and quantitative results in less than four hours. This helps the physician in patient management and disease monitoring and saves the expenses of patients on treatment, which may be very expensive like the antiviral therapy for AIDS.

What is the brand loyalty of current Molecular Diagnostics instruments users?

Considering the importance of molecular diagnostics many authorized international organisations like WHO, NIBSC, CDC are working towards the universal standardization of kits and instruments used for molecular diagnostics, units used for reporting and guidelines for patient therapy. For molecular diagnostics, it is very important to use the instruments and kits, which are licensed, have the trace ability and are validated as per WHO criteria and or as per the IVDD guidelines for CE mark or FDA approved. These kits eliminate the possibilities of false results and thus will make molecular diagnostics acceptable and affordable in India.

Please comment on emerging trends and new technologies.

Molecular diagnostic methods typically involve probing a sample directly or following an amplification step (as with polymerase chain reaction tests). PCR and variations of this method have become increasingly popular for clinical diagnosis. Nucleic acid primers bounding genetic regions that are unique to the pathogens are used to amplify DNA or RNA sequences within the organism, bypassing the need for the isolation of a pathogen in culture. Currently the PCR and Real Time PCR is the most popular technology used in India. Other technologies include NASBA, TMA, bDNA and Hybrid Capture. Multiplex PCR is widely accepted.

What factors will impact the future outlook for Molecular Diagnostics over the next five years?technology

India ranks second largest in the number of people living with HIV. Most of the deaths can be prevented with antiretroviral therapy. WHO has also set a target of providing antiretroviral therapy to three million people in developing countries. Molecular diagnostics plays a critical role in diagnosing HIV infection and AIDS management. Tuberculosis is also a major problem in India. More than 10 per cent of patients develop active disease. Drug resistance strains are now found in newly diagnosed, treatment naïve patients. Percentage of multi-drug resistant cases is increasing. MDR TB is 100 fold more expensive to treat than the cases of susceptible TB. HIV/TB coinfection is increasing. Prevalence of infections of HBV, HCV, CMV, HPV, leptospira, dengue, malaria, influenza etc is also high. These infections change the social, moral, economic and health status in a short span. Use of sensitive, specific and rapid technologies is essential for early diagnosis and treatment of these infections, but this important aspect is neglected in India. Many laboratories are still using conventional serological methods. Opposed to serological methods Molecular diagnostics allows a direct verification of the presence of viruses, bacteria and parasites in a wide range of sample materials in very short time. Hence, false negative results due to the absence of specific antibodies during so called window periods are considerably reduced.

Molecular diagnostics plays important role in detection of these infections and also in monitoring patient for the effectiveness of antiviral therapy using viral load. The diagnosis of infectious diseases is one of the main applications of molecular diagnostics in clinical testing in India. But, this technology is still very expensive in India because of the investment required for the lab set up, instruments and reagents. Molecular diagnosis offers better sensitivity and specificity, but this technology fails, if the reagents used for this testing are not standardized and validated. Low quality and not standardized reagents can lead to false results and can bring the legal problems, embarrassment for laboratory.

India is emerging as the global hub for health industry. Clinical diagnostic laboratory business is also growing. Clinical research is gaining importance. Many hospitals, laboratories prefer to have accreditations like JCI, CAP and NABL to maintain the quality and to be competitive in this market. India also has the higher prevalence of infectious diseases like tuberculosis, AIDS, hepatitis, genetic disorders like thallaeseamia. In this scenario, molecular diagnostics has a huge potential in India.

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