Lab of the Future Series – Molecular Diagnostics

The Opportunity in Molecular Diagnostics?

?The COVID-19 pandemic has made RT-PCR a household name known to all from the humble rickshaw-wala to every small and large business owner and administration officer in the country. If you a lab manager or owner, considering venturing into RT-PCR and other molecular diagnostics for COVID-19 and beyond, this article is for you.?

What are molecular diagnostics??

Medical molecular diagnostics encompasses a range of diagnostics techniques that rely on identifying specific genetic sequences in genomes of humans or pathogens. It helps identify source of infections, genetic disorders, malignant tumors and other ailments and can provide important information to guide course of treatment.??

There are a variety of molecular diagnostic techniques like PCR, microarrays and sequencing. However, real-time PCR remains the most widely used in clinical diagnostics. Real-time PCR involves isolating the RNA / DNA and amplifying in a chain reaction (hence the name Polymerase Chain Reaction or PCR).?

Where are they used beyond COVID-19??

Real-time PCR assays are the cornerstone of a variety of diagnostics pathways beyond COVID-19 such as those used to detect from drug resistant strains of TB, infectious agents like Hepatitis and HIV, respiratory infections like RSV and Influenza, and cancer-causing viruses like HPV. PCR assays are also available for detection of sub-types / strains of vector borne diseases like Malaria, Dengue and Chikungunya and increasing in popularity. PCR panels are being increasingly used in oncology to detect cancerous mutations in the patient genome.??

PCR assays very often are the most sensitive, specific and earliest diagnostic tool, especially for viral infections. They also lend themselves very well to identifying specific variants or genotypes of a virus making it easy to predict antimicrobial resistance and choose the right treatment pathway.?

Why are they important??

PCR and similar techniques have a bright future. With increasing urbanization the prevalence of respiratory, vector borne and other infections as well as cancer will continue to rise along with anti-microbial resistance. The COVID-19 pandemic has created unprecedented awareness among clinicians and patients regarding molecular diagnostic techniques. It has reset the healthcare system’s expectations around how much these tests should and could cost, making these tests 3-4x affordable. Innovations like extraction-free test kits, isothermal amplification and compact PCR systems are reducing the complexity and investment need of a molecular diagnostic setup. All these could see the number of molecular diagnostics tests explode over the coming years. According to analysis by Tata MD, Molecular market growth numbers per estimates are 14%

How do you evaluate whether molecular diagnostics is right for your lab??

There are a few important considerations to keep in mind before you decide to take the plunge in molecular diagnostics.?

First, it is important to conduct due diligence of the demand and supply dynamics in your area of operation and ensure the market is not saturated with established molecular setups. If required, evaluate an alternate location.?

Second, it is critical to have access to a good team starting with a well-trained microbiologist. The team must of course be well-versed with real-time PCR, but also have keen attention to detail and commitment of strong lab management practices.??

Third, a well-functioning molecular diagnostics lab will require a dedicated 3-room setup, BSL-2 level facility, -20 degree freezers and specialized real-time PCR equipment. It is highly recommended that molecular labs have NABL accreditation. You must be able and willing to upgrade your facilities as required and undergo the accreditation process. A full molecular setup can add up to an investment of Rs 75 lacs to Rs 1 Cr and breakeven may take 12-18 months. It is important to prepare yourself financially and temperamentally. Once this initial period is through, a molecular diagnostics setup can yield strong returns and impact.?

Fourth, it is important to choose the right PCR platform. From PCR to isothermal amplification, open systems to closed-cartridge based ones, Indian makes to imported ones, there is a wide variety of platforms with significant tradeoffs in performance, assay menu, infrastructure requirements, workflow complexity and cost. While some new POC-like closed PCR systems have simpler infrastructure requirements, the short assay menu and cost-per-test (CPT) can be limiting factors with these systems.?

Finally, you must be willing and able to invest energy in awareness building of your molecular setup among physicians, patients, and other lab / collection partners post launch.??

Summary?

In summary, molecular diagnostics is an exciting area with strong potential for growth and innovation and lot of room for new players. However, it is important that you plan your entry carefully choosing the right platform and team and preparing well for the financial and operational investment and change.??

Over a series of articles such as these, we will endeavor to guide you these considerations and provide necessary toolkits such as ROI calculators and model lab designs. To know more reach out to us at?[email protected]

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