Thursday, 03 February 2022 07:10 AM
Company Update
AdOM Advanced Optical Technologies and Sheba Medical Center have launched the world's largest study for the detection of COVID-19 within the surface of the eye by a quick, noninvasive measurement of the tear film by the Tear Film Imager (TFI).
LOD, ISRAEL and DOVER, DELAWARE / ACCESSWIRE / February 3, 2022 / AdOM Advanced Optical Technologies LTD., a clinical development and commercial stage ophthalmic medical device company has partnered with Sheba Medical Center-Tel Hashomer in Ramat Gan, Israel to conduct one of the world's largest studies of its kind to determine if the Tear Film Imager (TFI) device can effectively diagnose and determine COVID-19 status in a fast, affordable, noninvasive assessment of eye's tear film.
The study will compare the use of the TFI vs current standard of care which is the PCR diagnostic test. Based on a successful proof of concept study at Wolfson Medical Center Holon, Israel, which demonstrated high specificity and sensitivity of the TFI vs PCR testing in COVID-19 patients, AdOM and Sheba Medical Center are conducting this clinical trial to validate in an "all comers" setting to see if the TFI can further demonstrate high equivalence to the existing standard of care and within the realm of a fast, non-invasive 40 second assessment of the tear film surface layers of the eye. The first patient has been enrolled and the study will be conducted over the next 30 days, with an expected enrollment of about 500 patients.
The TFI device is an ophthalmic, non-invasive medical device which is designed to simultaneously measure the muco-aqueous and lipid sublayers of the eye's tear film, and at a resolution depth of a few nanometers. In a mere 40 seconds per eye, the non-invasive exam provides clinicians a comprehensive assessment on the health of the tear film sublayers, all of which play an important role in the identification and treatment of specific ocular surface diseases. The TFI can reconstruct the tear film sub-layers at nanometer resolution and when a "virus layer" is presented, the TFI will observe and quantify it. The TFI is one of the only commercially available devices which has already proven to identify a virus within the surface of the eye. The previous proof of concept study at Wolfson Medical Center demonstrated the TFI can correctly identify COVID 19 positive or negative patients when compared to PCR.
Professor Eyal Zimlichman, MD, MSc (MHCM) Chief Transformation Officer at Sheba Medical Center and the Director of the ARC Innovation Center as Sheba added, "We have already seen that the TFI has high sensitivity and specificity compared to a PCR in a previously conducted pilot study. Our goal is to have hundreds of patients who are asymptomatic or symptomatic with COVID-19, irrespective of the variant and even those who have recovered, to see how the TFI device compares to the existing PCR standard of care. If successful, this fundamental study could serve to endorse the TFI technology for virus detection by the regulatory authorities".
"The world urgently needs new diagnostic tools to help assess and diagnose aggressive viruses in a non-invasive manner, and with speed and efficiency. Different SARS variants as well as aggressive flu variants are threatening the world population and we are developing the TFI virus detection technology for high sensitivity within these large groups" says John Abrams, MD President of AdOM, Advanced Optical Technologies, LTD. "The TFI could be a game changer by providing a fast, reliable, 40 second eye exam to screen people in malls, sporting events, transportation hubs, stores or any venue that may require rapid testing".
About AdOM Advanced Optical Technologies
AdOM is a development and commercial stage ophthalmic medical device company which uses hyperspectral technology to measure the dynamics of the tear film inner structures. Founded in 2008 and led by a team of scientists, AdOM's science driven approach led to the identification of advances in hyperspectral technology, and the use of artificial inelegance to help managing diseases of the eye. The TFI is the first device to be registered with the FDA and the company is focused on seeking regulatory authorization in other territories. For additional information about the company, please visit www.adom-tech.com
About Sheba Medical Center
Sheba Medical Center, Tel HaShomer is the largest and most comprehensive medical center in the Middle East, which combines multiple hospital facilities on its 200 acre campus, and is at the forefront of medical treatments, patient care, research, education and innovation. For the past three years (2019-2021), Newsweek Magazine has named Sheba one of the Top Ten hospitals in the world. For more information, visit: eng.sheba.co.il
AdOM Advanced Optical Technologies
www.adom-tech.com
Contact: Stan Miele (919-410-0504)
Galia Goldenberg (+972-544248709)
[email protected] / [email protected]
Sheba Medical Center
Contact: Steve Walz (972-52-233-0430)
[email protected]
SOURCE: AdOM Advanced Optical Technologies Ltd.