Frequently Asked Questions

As discussed on the Challenge page, PCR provides higher accuracy rates than any other widely available testing methodology. Specifically, it provides higher sensitivity (lower false negative) and higher specificity (lower false positive) rates. For this reason, PCR is considered a “gold standard” for infectious disease testing. This is the same testing methodology 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.

As described on our PCR Testing page, a PCR test has three basic steps: sample preparation, amplification and detection. Typically, each of these steps requires relatively expensive equipment, a lab environment and a highly trained technician or scientist to perform the steps. For this reason, PCR testing is rarely done outside medical facilities, but instead requires a sample to be provided, generally by courier or mail, to a laboratory for processing. This creates delays in reporting results, often by several days, and other logistical challenges, as described on the Challenge page. Our technology works by miniaturizing and integrating the same three steps that are used in traditional laboratories to perform PCR testing: sample preparation, amplification, and detection.

Generally speaking, PCR machines are big, bulky, expensive machines that are used in a medical facility or laboratory by specially trained experts, as noted above. PCR (thermocycler) machines also do not typically perform the sample preparation or detection functions necessary to process patient samples. The Nuclein™ Hand-Held PCR Test, in contrast, is designed to be a disposable, all-in-one, self-test for infectious disease diagnosis. It uses standard, real-time PCR, requires no technical expertise, and delivers battery-powered, sample-to-answer results in under one hour, without the need to mail in a sample. Accordingly, it could enable robust expansion in the types of interactions medical professionals can have with their patients via telemedicine. Please note that this testing device will require FDA regulatory clearance and is intended for use in consultation with a medical professional, in person or via telemedicine.

Generally speaking, the Nuclein™ Hand-Held PCR Test is designed to be disposable and requires no technical expertise. It provides results in under one hour and was designed to be used anywhere it is needed, from the most remote corners of the world to someone’s home. At the same time, it is important to note that this type of at-home use would need to be specifically authorized by the FDA. 

As described on The Challenge page, while our current testing approaches–immunochemistry and nucleic acid detection–are invaluable in the fight against infectious disease, they unfortunately suffer from certain limitations. Rapid and inexpensive “antibody” and “antigen” testing can often be used without technical expertise. Their usefulness can be limited, unfortunately, because their sensitivity is typically low, leading to a high false negative rate. Another widely used approach, nucleic acid detection, which includes polymerase chain reaction (PCR) testing, is highly accurate (meaning highly sensitive and specific, or low rates of false positive and false negative), but typically requires expensive benchtop infrastructure and specially trained technicians to conduct a number of steps, as described on our PCR Testing page. As described on Our Solution page, our testing device is designed to addresses these challenges. Among other things, because it can act as a self-test, it could enable robust expansion in the types of interactions medical professionals can have with their patients via telemedicine.

We anticipate moving into product manufacturing soon with the objective of having a COVID-19 testing device on the market in 2021. Please note that this testing device will require FDA regulatory clearance. 

Yes – we will work closely with all appropriate government regulatory agencies to ensure that our technology meets the relevant regulatory requirements in any jurisdiction where our devices are made available for sale. 

While the device is inexpensive compared to other PCR testing solutions, we have not yet determined its final cost. At the same time, we are confident that it will cost no more than the otherwise available testing that is receiving healthcare reimbursement, particularly for the COVID-19 test.

Like many electronic devices, the disposal of the Nuclein™ PCR Device in the United States may be governed by various laws, rules, and regulations at the federal, state, and local levels.  Outside of the United States, various jurisdictional and country-specific laws, rules and regulations may also apply. Further guidance will be made available upon market availability of the Nuclein™ PCR Device.

Absolutely. Our company began developing the technology long before the COIVD-19 pandemic as a general infectious disease detection platform. Because the Nuclein PCR device runs standard real-time PCR technology, it can be utilized as a general infectious disease diagnostic platform.

Definitely. PCR testing has a tremendous number of applications beyond detecting infectious disease. Areas of potential application include genomics, environmental testing such as agriculture, aquaculture and water testing, as well as forensics, and general field-based research. We are excited to be able to apply our technology to more of these areas over time.

Nuclein LLC was founded in 2017 by biotechnology entrepreneurs Alan Blake and Dr. Richard Crockett. The company’s mission has been to create a hand-held, disposable, all-in-one infectious disease diagnostic platform, which delivers battery-powered, sample-to-answer results in under one hour, without the need for technical expertise or mailing in a sample.

Mr. Blake and Dr. Crockett’s last company was Yorktown Technologies, best known for GloFish, a high-profile, public brand (sold in Walmart, PetSmart and Petco) that operated under FDA oversight, and ultimately sold to a publicly traded company. They are joined by a highly accomplished board, including Dr. William Cunningham, a former Chancellor of The University of Texas System and David Shockley, CEO of a successful medical device manufacturing company. Nuclein is headquartered in Austin, Texas.