Frequently Asked Questions
Below are some frequently asked questions that may be helpful:
What technology does the Nuclein™ Hand-Held PCR Test use?
The Nuclein™ Hand-Held PCR is designed to miniaturize and integrate the same three steps that are used in traditional laboratories to perform PCR testing: sample preparation, amplification, and detection. Polymerase chain reaction (PCR) technology was originally invented by Dr. Kary Mullis in 1983 and subsequently won the Nobel Prize for his discovery in 1993. PCR has been used for decades in countless biology labs around the world. The technology can directly detect a pathogen (such as a virus or bacteria) through the presence of its unique genetic sequence. The specific type of PCR used is called “real-time” PCR. This is a standard PCR variety used in labs around the world, including by the U.S. Centers for Disease Control and Prevention (CDC), other government agencies, and commercial labs used to confirm infections such as influenza and COVID-19. For more information about how our testing device works, please see the “How It Works” section on Our Solution page.
Why is PCR testing so important for identifying infectious disease?
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.
How is PCR typically used today to detect infectious diseases?
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.
How is your Nuclein™ Hand-Held PCR Test device different than other PCR machines?
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.
Can this act as an at-home, self-test in combination with 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. Please also note that, while the FDA has stated that they, “see value in safe and accurate tests that may include home collection” they have not, to date, authorized any such at-home use.
How is this different than other types of testing solutions?
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.
When will the Nuclein™ Hand-Held PCR Test be ready for use with COVID-19 testing?
We anticipate moving into product manufacturing soon with the objective of having a COVID-19 testing device by fall 2020. It is important to note that this is an accelerated timeline in response to the COVID-19 crisis and there is a significant risk that our testing device will not be ready this year. Our team is working tirelessly and will do everything possible to have our technology available in time to help with this crisis, but we unfortunately cannot make any timeline guarantees. Please note that this testing device will require FDA regulatory clearance. It is also important to note that meeting our timeline will require active engagement from various industry and governmental partners. If we all work together, we believe we can succeed and make a meaningful difference in the COVID-19 pandemic.
What else should I know about Nuclein™ Hand-Held PCR Test availability?
Like many people in our community, country and around the world, we are doing our absolute best to help in this crisis. We cannot make any guarantees, except that we understand the life and death stakes involved with COVID-19 testing; everyone involved in this project has loved ones at high risk from this disease. We will work tirelessly to launch our testing device while recognizing that a rushed product that fails to meet the needs of the patient will not be helpful to anyone. We also want to emphasize that our testing device is intended for use in consultation with a medical professional.
What is your exact stage of development?
We have used contrived samples on the Nuclein™ Hand-Held PCR Test device to detect nucleic acid targets in bacteria and other cells directly from saliva, automatically processing the samples and determining in under an hour whether a particular target is present. We are in the process of adapting our device to work with SARS-CoV-2, the virus that causes COVID-19. From there, we will need to move into manufacturing and collect clinical data before we can scale manufacturing, obtain FDA regulatory clearance, and ultimately make our devices available.
How could you get to market faster?
Our team is working tirelessly to make the Nuclein™ Hand-Held PCR Test available as quickly as possible. At the same time, successful technology development and manufacturing takes time. Cutting corners typically results in bad outcomes and failed products, so “rushing” the process is not an option for us.
We believe that we could benefit from the assistance of certain governmental agencies and strategic partners, such as large-scale manufacturers and reagent-producing life science companies, to help with certain steps in the process. We are working to contact potential partners as helpful.
Does your PCR device still need to be reviewed by government agencies?
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. In the United States, like many governments around the world, the United States government has publicly been very clear that they are committed to doing everything they can to help COVID-19 related tests get to market without delay. Their actions in this regard have been unprecedented and very helpful.
Have third-party experts reviewed your technology?
To date, we have maintained confidentiality around our work and have had limited outside review. As we are now sharing our work publicly, we have started working with third-party experts to review our technology and will update this page as we have more information to share. In the meantime, if you are a government or academic expert, particularly in the area of PCR, and you would like to review our technology, please contact us. While we welcome third-party validation efforts, we ask for understanding as we will be limited in the number of such engagements we can handle at any given time. For now, more information about our specific approach, please visit the “How it Works” section on our Our Solution page.
What is the anticipated cost of the Nuclein test per unit?
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.
How should this device be disposed of after it is used?
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.
Who can I contact with questions about Nuclein?
We are working very hard to complete development and move our technology into manufacturing. As our goal is to devote all available resources to moving our technology to market, we may not be able to respond in a timely manner to all inquiries. As we hope everyone will understand, we want to minimize expending resources on anything other than critical development and manufacturing work.
Are you open to media interviews?
In the interest of communicating to the public, we are planning to arrange a limited number of interviews. Otherwise, we would strongly prefer not to engage in media interviews at this time. We understand the intense interest in this space, but we cannot afford to lose focus from our critical goal of getting the Nuclein™ Hand-Held PCR Test on the market by the end of this year to help with COVID-19 testing. As we move closer to market launch of our testing device, we look forward to additional engagement with the media and public.
How can I learn about opportunities to become a strategic partner?
We will need help from strategic partners in the areas of large-scale manufacturing and reagent-producing life science companies. If you think you can help, please contact us through our contact page.
I am a government official. How can I reach you?
We welcome engagement with government officials. If you are a government official, please contact us through our contact page. While we welcome this contact, we ask for understanding that our response may be delayed.
Is this technology useful for detecting infectious diseases other than COVID-19?
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.
Are there areas besides detecting infectious disease where the Nuclein™ Hand-Held PCR Test could help?
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.
Can you tell me more about your company?
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.
We strive to answer as many questions as possible through this FAQ page. If your question is not answered above, you may contact us through our contact page. Please understand that we are focused on launching our product as soon as possible, and we may not be able to respond to every inquiry.
Please note: If you have a medical question or a medical emergency, please contact a qualified medical professional. If you are looking for one of our Nuclein Hand-Held testing devices, please note that our devices are currently limited by federal law to investigational use and not available for sale.