Policy & Regulation
Nuclein to Expedite Commercialisation of Hand-Held PCR Test to Aid in COVID-19 Pandemic
25 March 2020 - - US-based diagnostics company Nuclein LLC plans to expedite the commercialisation of its Nuclein Hand-Held PCR Test, the company said.

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.

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 aluminium.

Polymerase chain reaction is a widely used technology and accepted as the gold standard in nucleic acid detection. It is the same technology used by the US Centers for Disease Control and Prevention, other government agencies and commercial labs to confirm infections such as influenza and 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.

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.

Nuclein LLC was founded in 2017 by experienced biotechnology entrepreneurs Alan Blake and Dr. Richard Crockett.


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