Technological advancements have revolutionized the healthcare system by making it more personalized, proactive, and convenient. Molecular diagnostics (MDx) is the most accurate and advanced diagnostic technology that serves the diagnostics needs of healthcare systems. In recent years, companies have been focusing on developing advanced diagnostic kits that can yield faster results than traditional kits. These kits help healthcare providers make crucial medical decisions promptly, such as the development of ultra-fast PCR kits to minimize the time required to generate test results. For instance, in June 2021, Thermo Fisher Scientific (U.S.) developed the new, innovative, and portable Accula SARS-CoV-2 Test offering gold-standard Reverse Transcription Polymerase Chain Reaction (RT-PCR) detection of SARS-CoV-2 in a point-of-care format. The test delivers results in 30 mins, whereas the conventional RT PCR method takes around 2–3 days to produce results. In February 2021, Eurofins Technologies (Luxembourg) launched the GSD Nova Prime SARS-CoV-2 Direct RT-PCR kit for the qualitative detection of SARS-CoV-2, through human nasopharyngeal swabs. The GSD Nova Prime SARS-CoV-2 Direct RT-PCR kit shortens the complete turnaround time of the test, providing results in approximately one hour without compromising accuracy, allowing for a higher processing capacity.
Moreover, traditional PCR test has transitioned into multiplex capabilities, including simultaneously detecting two or more pathogens. Multiplex diagnostic tests provide higher accuracy for critical care, which leads to pathogen-specific treatment. Also, the emergence of a new CLIA-waived molecular PoC platform is widely accepted globally because traditional POC tests lack sensitivity. Those established tests could be replaced by molecular diagnostics that are simple, easy to use, and highly accurate compared to the former standard methods.
Integrating digital technologies in clinical and ambulatory settings help in improving doctors’ and physicians’ ability to reach an initial diagnosis. Also, the digitalization of diagnostic services helps in the documentation, analysis of patient data, and test results which further minimizes human error and makes treatment and care pathways more consistent. Due to this, more and more healthcare providers worldwide are adopting digitally compatible diagnostic systems and devices to instantly store patient data and view patients’ medical histories.
Additionally, developments are made to make diagnoses personalized. Companion molecular diagnostics measure the levels of proteins, genes, or specific mutations to reveal specific and effective therapies for an individual’s condition. Companion diagnostics (CDx) are a form of personalized, stratified, and precision medicine that individualizes a patient’s treatment. CDx has expanded from oncology drugs to multiple therapeutic areas, and the number of combinations has grown significantly over the years. Also, personalized medicine for infectious diseases helps to orient the molecular management of infections. Molecular microbiology offers technologies that can detect and identify microorganisms rapidly. Determining the pharmacogenetic profiles of patients suffering from infectious diseases provides an additional assessment of the drug metabolizer phenotype and/or the risk of potential adverse drug interactions. Personalized medicine is thus expected to help develop new therapies and new methods for disease detection. Companies in this market are collaborating for the development and commercialization of CDx due to the growth potential of companion diagnostics. This will help the companies expand their product portfolios and strengthen their presence across regions. For instance, in April 2022, Amoy Diagnostics Co., Ltd. (China) and AstraZeneca plc (U.K.) signed a collaboration agreement for multiple companion diagnostics programs in China, Japan, and the European Union. Through this collaboration, the companies aim to co-develop and commercialize AmoyDx companion diagnostic (CDx) assays with AstraZeneca.
Thus, technological advancements in molecular diagnostics are expected to drive the global market at a CAGR of 5.6% to reach $46.69 billion by 2030, according to Meticulous Research®.
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