Nuclein LLC announces plans to expedite the commercialization of its Nuclein™ Hand-Held PCR Test.
The company’s disposable, all-in-one, self-test device for infectious disease diagnosis does not require technical expertise and provides battery-powered, sample-to-answer results in under one hour, without the need to mail in a sample. The company anticipates moving into product manufacturing soon, with the objective of launching its COVID-19 Hand-Held PCR Test by fall 2020.
This announcement represents Nuclein’s first public release of information about its patent-pending technology and serves as a response to the call for a “Manhattan Project” for diagnostic testing. This also serves as a response to White House Coronavirus Response Coordinator Dr. Deborah Birx’s interest in developing a COVID-19 self-test.
Please note that the Nuclein Hand-Held PCR Test will require FDA regulatory clearance and is intended for use in consultation with a medical professional, in person or via telemedicine.
Overview of the Nuclein Hand-Held PCR Test
Intended for use in consultation with health care professionals, in person or via telemedicine, the Nuclein Hand-Held PCR Test is a disposable, all-in-one test for infectious disease diagnosis. It uses standard, real-time PCR, requires no technical expertise and delivers battery-powered, sample-to-answer results within one hour, without the need to mail in a sample.
The Nuclein Hand-Held PCR Test device is designed to accept a swab or saliva sample directly from patients. The real-time PCR diagnostic process can be activated by simply pushing a button, after which point the device automatically prepares and analyzes the sample. The negative or positive test results are then automatically displayed on the LCD screen in under one hour.
The hand-held device is approximately the size and weight of a soda can (weight: 12 oz, dimensions: 6” long, 2” wide and 3” tall) and composed of a combination of plastic and aluminum.
Polymerase chain reaction (PCR) is a widely used technology and accepted as the gold standard in nucleic acid detection. It is the same technology used by the U.S. Centers for Disease Control and Prevention (CDC), other government agencies and commercial labs to confirm infections such as influenza and COVID-19.
Application for COVID-19
The disposable Nuclein Hand-Held PCR Test device provides PCR point-of-care results in less than one hour without the need for additional instruments. This supplements the current testing paradigm, the limitations of which are discussed on our Challenge page. These hand-held PCR devices can be rapidly and widely deployed to wherever they are needed and serve as a self-test when employed in conjunction with telemedicine.
Status of Availability
Nuclein is seeking to make its Hand-Held PCR Test available by fall 2020 to assist with the COVID-19 crisis. Currently, the company is working to complete development and move into the product manufacturing phase. Please note that this testing device will require FDA regulatory clearance. Click here to learn more.
Alan Blake, CEO of Nuclein: “We have heard the call of former FDA Commissioner Scott Gottlieb for a ‘Manhattan Style project for diagnostics,’ as well as Dr. Deborah Birx’s interest in a self-test solution. We believe our disposable PCR diagnostic platform is a great candidate to help with this, and we are working tirelessly to move this forward on an accelerated timeline. We will ultimately need help from reagent producers, large-scale manufacturers and government agencies to meet our fall 2020 timeline, but we are confident that we can succeed if we all work together.”
Dr. Richard Crockett, President of Nuclein: “We have been working on the Nuclein Hand-Held PCR Test for several years prior to the COVID-19 pandemic, and we recognize the important role this technology advancement could have in aiding the response. Providing results in under one hour, without the need to mail in a sample, would allow faster, smarter decisions and help us to flatten the pandemic curve.”
William Cunningham, Ph.D., Chairman of the Board, Nuclein and Former Chancellor of the University of Texas System: “I have worked closely with Alan Blake and Dr. Richard Crockett for more than 20 years. They are innovative entrepreneurs who sought to rethink the current PCR testing paradigm to advance infectious disease diagnosis years before COVID-19 emerged. On behalf of the board, we call on government regulators, scientists and large-scale manufacturers to help us complete this mission by fall 2020.”
For more information, go to www.nuclein.com
