AI-based IVD rises to challenge of novel coronavirus

2019 08 08 22 40 7691 Carlson Bruce Aacc 2019 400

While artificial intelligence (AI) has principally been used in imaging applications and digital pathology, use is growing in IVD products during the public health crisis brought on by the novel coronavirus, or SARS-CoV-2.

AI in healthcare refers to the use of complex algorithms designed to perform certain tasks in an automated fashion. The algorithms can review, interpret, and even suggest solutions to complex medical problems.

In the past few years, there have been extraordinary advances in AI in clinical medicine. More products have been cleared for clinical use, more applications have made the transition from research to market, and many more are still in development. Diagnostics companies in collaboration with AI companies have begun implementing increasingly sophisticated machine-learning techniques to improve the power of data analysis for patient care. The goal is to use the algorithms that are developed to standardize and aid interpretation of test data by any medical professional irrespective of expertise. This way, AI technology can assist pathologists, laboratorians, and clinicians in complex decision-making.

New applications of AI are in development to predict outcomes such as diagnosis, death, or hospital readmission; to improve upon standard risk assessment tools; to elucidate factors that contribute to disease progression; and to advance personalized medicine by predicting a patient's response to treatment. AI tools are used to review data and to uncover patterns in the data that can be used to improve analyses and uncover inefficiencies.

With most healthcare authorities now focused on COVID-19, it is a testament to AI's adaptability that several companies are already employing it to help meet the diagnostic challenge.

Total COVID-19 care

South Korean firm JLK Inspection has added another dimension to reverse transcription polymerase chain reaction (RT-PCR) testing for COVID-19 with AI and imaging enhanced diagnostic aids. The system starts with a PCR test and then adds AI-enhanced x-ray analysis to continue to inform providers of disease progression or remission. The company's AI Total COVID-19 Care product is based on its AIHuB, which conducts analysis from MR, CT, x-ray, and mammography images with an AI-enabled technology. A wide variety of diagnostic techniques are used to pinpoint illnesses such as stroke, Alzheimer's disease, and cancer.

The approach has been applied to COVID-19 in South Korea, where JLK has connected its system to an RT-PCR test. The product triages positive results as severe or mild to allow for prioritizing and providing the proper treatment to the infected.

Coronavirus surveillance

In March, Persivia, a provider of real-time bundled payment, value-based care, population health, and quality management solutions, announced the launch of a new COVID-19 surveillance module within its Soliton AI engine. Delivered as part of its CareSpace platform, this module uses data from multiple sources to identify patients who may have novel coronavirus infection. The ruleset may help healthcare professionals more effectively target patients who need to be tested, according to the company. The new functionality is available to Persivia's installed base of 20 million covered lives across the U.S. The ruleset is being offered at no cost to public health departments across the country to help them manage the ongoing public health crisis. It took less than 10 days for Persivia to bring this ruleset to production on its flexible, modular AI system.

Intelligent rapid test

Also in March, Surgisphere of Palatine, IL, announced the availability of its new AI-based rapid diagnostic test for COVID-19. With advanced machine learning, Surgisphere has developed an intelligent tool that uses three common lab tests to identify patients likely to have COVID-19 infection. The company's cloud-based healthcare data analytics platform (QuartzClinical) identified patients diagnosed with COVID-19 in five countries. The company then created a machine-learning model using decision tree analysis with clinical and lab data on 430 patients to develop the decision-support tool. The test is available for public use.

Remote monitoring

Biofourmis, a provider of digital therapeutics that power personalized predictive care, announced that its technology is being leveraged in a remote monitoring and disease surveillance program in Hong Kong involving patients with diagnosed or suspected novel coronavirus. The program, which is administered by the University of Hong Kong, also includes Hong Kong-based Harmony Medical, which is Biofourmis' joint venture partner for the China region.

Diagnosed and potentially COVID-19-infected patients are being monitored with Biofourmis' Biovitals Sentinel platform, a turnkey solution that the company built in less than two weeks specifically for this initiative by customizing its U.S. Food and Drug Administration (FDA)-cleared AI-powered Biovitals analytics platform.

Biovitals Sentinel's 24/7 remote monitoring technology and analytics are providing clinicians involved in the COVID-19 program with clinical decision support for early identification of any physiological changes that could indicate deterioration, and to enable earlier interventions for better outcomes. The goal of the program is to leverage Biovitals Sentinel to remotely monitor patients and identify COVID-19-related physiological biomarkers that indicate deterioration in patients. The hope is that the effort also will rapidly lead to a better epidemiological understanding of COVID-19 to improve outcomes as more people become infected.

Home-based pathology

Philips announced that the FDA has granted a waiver for the use of readily available consumer monitors at home with its IntelliSite Pathology Solution. Pathologists, who may not be able to work onsite due to the current COVID-19 emergency, may now work from home to review pathological cases and so prevent any delay in critical patient care. The IntelliSite Pathology Solution is designed for in vitro diagnostic purposes, helping pathologists to review and interpret digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue samples.

Pathologists, who play a crucial role in the detection, diagnosis, and treatment of a broad range of diseases, including cancer, are under enormous pressure to maintain high-quality patient care despite heavy workloads. Recently, pathologists' societies and industry associations successfully advocated for a waiver from remote pathology restrictions during the public health pandemic. The waiver gives pathologists a temporary break from CLIA regulations stating that diagnostics must be performed at certified facilities, opening the door for remote readings.

Bruce Carlson is the publisher of Kalorama Information, part of Science and Medicine Group.

Disclosure: is a sister company of Kalorama Information.

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