In vitro diagnostics – Current and emerging trends

In vitro diagnostics (IVD) are tests used on biological samples (such as tissues, blood, urine, or saliva) to determine the status of a person’s health. Over the years, IVD industry is constantly evolving and is presently at the intersection of innovation and expansion. The industry incorporates latest diagnostic technologies with their applications in clinical chemistry, immunology, hematology, molecular diagnostics, and microbiology.

The Covid-19 and the post-pandemic era witnessed unprecedented demand for IVD and will further see rising trends in all segments, particularly molecular diagnostic tests and point-of-care tests (POCT). Over the period, latest technologies like PCR, NGS in molecular diagnostics are improving, and have a high specificity and sensitivity improving pathogen or mutation detection.

Technological advancements have been making tests more accurate, convenient, faster and cheaper. IVD industry needs to incorporate innovations going further beyond diagnosis and enable personalized medicine, which involves tailoring treatment plans to an individual’s specific genetic makeup. Complex disease profile requires development of IVD tests that can identify specific biomarkers or genetic variants. With increasing focus on precision medicine, companion diagnostics is being used for monitoring patients as targeted therapy is becoming common in oncology and other fields of healthcare.

Artificial intelligence (AI) and machine learning (ML) are transformative forces in IVD industry, particularly useful in biochemistry segment. The clinical chemistry and immunochemistry is using automation, simultaneously continuously evolving by improving precision, accuracy, and further raising throughput. Recent advancements in immunochemistry like continuous innovation enable identification of biomarkers and trace analytes in complex matrices with greater precision.

A multiplex assay is emerging as a tool, changing IVD landscape as it detects various analytes by combining tests in a single panel. These assays provide advantage of saving sample volume and shorter processing time by improving workflows.

Besides the core diagnostics, latest digital diagnostics solutions have vast scope, provided they add value to health system and help in improving patient outcomes. Recently, there has been a proliferation of syndromic/multiplex tests like biofire panels, which detect a broad spectrum of probable pathogenic organisms in a single test with improved sensitivity, specificity, and quicker turnaround time.

Digitization uses digital technologies like digital scanners, visualization software and the incorporation of AI-based algorithms for digital pathology. This helps in assisting the pathologist and reduces risk of inaccuracy.

Using digital technology aids in clinical decision-making, cheaper diagnoses, prognosis, and predictions of diseases and integration of diagnostic data.

The discovery and proof of biomarkers enables new test development and its introduction in the market. This whole process needs investments in research and development, regulatory approval, and compliance like registration with Central Drugs Standard Control Organization (CDSCO) and furthermore extensive validation before launch, with adoption of technology and acceptance by users that it has benefit over existing one. Also test should be cost effective for healthcare systems.

AI and robotics have had a major role to play together in IVD industry in recent years. The integration of IoT (Internet of Things) with IVD enables automation and streamlines processes in IVD testing. Integration of digital health technologies, such as AI, smart phone apps, wearable sensors like digital watches are new innovations in IVD industry. POCT devices can be used to remotely monitor disease progression or response to management and provide valuable information in real time to clinicians. Miniaturization and microfluidics enabled development of lab-on-a-chip that integrates multiple lab functions onto one single chip, which has further potential to revolutionize IVD industry.

In conclusion, the future of the in vitro diagnostic industry is promising and exciting with substantial growth along with new possibilities as there will be transformation in the way we diagnose and manage disease.