As the number of infections gets higher, experts from different fields are trying to find ways to help stop the disease from spreading
The latest situation report from WHO points to more than 105,000 confirmed cases globally. As the number of infections gets higher, experts from different fields are trying to find ways to help stop the disease from spreading. In this interview, KA Imaging’s CTO, Karim S. Karim, discusses how Reveal’s technology could strengthen efforts against the spread of the novel Coronavirus. Reveal is undergoing IEC testing and will be submitted to the FDA for US 510K regulatory clearance in 2020.
How can Reveal’s technology help diagnose of COVID-19?
Karim: Dual-energy subtraction radiography is widely known for classifying lung nodules for diseases like lung cancer, pneumonia and tuberculosis. Initial studies have demonstrated the improvement of the area-under-the-curve for detecting pneumonia from 0.84 to 0.88 by using the technique1. Thus, the use of dual-energy X-ray in COVID-19 to detect manifestations of the disease in the lungs may contribute to improve diagnosis – especially because Reveal is the only available option that is motion artifact free.
What does “motion artifact free” mean?
Karim: Current dual-energy X-ray implementations are not mainstream because they require acquisition of two X-ray exposures at different energy levels. This double-exposure leads to blurring artifacts due to heart-beating or breathing motion, producing streaks. These artifacts often invalidate the resulting images and force retakes, which is time – and money – consuming. This problem doesn’t happen with Reveal. Our detector uses a patented three-layer sandwich design to acquire images simultaneously from only one exposure. Post-acquisition imaging processing allows the creation of high-quality traditional DR, bone subtracted, and tissue subtracted images. Price also acts like a barrier. A full new dual-energy system can cost as much as half a million dollars, and not many institutions have the resources to invest in this type of high-end technology. Reveal, on the other hand, was designed to be retrofittable. It means that, for a quarter of that price, we can upgrade an existing conventional X-ray system. The install base of all conventional X-ray systems is around 500,000 globally.
Why is early diagnosis so important?
Karim: The World Health Organization says that “early epidemiologic and clinical investigations are critical to carry out early in an outbreak of a new virus”. False negative tests can play an important role in spreading COVID-19, as the patient remains untreated and in contact with others. When the virus is novel, as COVID-19, the challenges are even greater. Recent experiences have shown that testing for viral RNA may not suffice as the only test to confirm or rule out the infection. . This is where we can help, as radiological imaging, in some cases, has indicated presence of pulmonary disease even days earlier than PCR testing2. Moreover, radiological imaging can follow the progress of COVID induced pneumonia over time enabling timely decision making about treatment efficacy or need for ventilators.
What about CT?
Karim: CT is the current clinical reference standard in the detection of pulmonary manifestations of infectious diseases. Though effective, this method suffers from low availability and still exposes patients to high doses of radiation. Even moving the patient to the CT location can represent an extra risk of spreading the virus. The method is undeniably essential but developing alternatives that can increase access and safety is urgent.
What are your next steps?
Karim: A clinical trial comparing conventional X-ray, dual energy X-ray, and computed tomography (CT) is necessary to quantitatively establish the relative performance of all three radiological methods of detecting COVID-19. KA Imaging is actively seeking clinical and government partners to obtain the necessary clinical evidence to determine deployment conditions and to accelerate adoption.
References:
- Li F, Engelmann R, Pesce L, Armato SG 3rd, Macmahon H. Improved detection of focal pneumonia by chest radiography with bone suppression imaging. Eur Radiol. 2012 Dec;22(12):2729-35. doi: 10.1007/s00330-012-2550-y. Epub 2012 Jul 5
- Wong, H. Y. F., Lam, H. Y. S., Fong, A. H.-T., Leung, S. T., Chin, T. W.-Y., Lo, C. S. Y., … Ng, M.-Y. (2020, March 27). Frequency and Distribution of Chest Radiographic Findings in COVID-19 Positive Patients. Retrieved from https://pubs.rsna.org/doi/10.1148/radiol.2020201160
