XCR stands for Xtreme Chain Reaction, a 4th generation nucleic acid technology which means we are testing people at the DNA level. The Pyramid can produce fully automated test results in about 10 minutes instead of usual hours or days. 3rd generation nucleic acid testing is about 95-99% accurate. We can provide the same level of quality of testing but dramatically faster on any current PCR platform but even faster on the Pyramid.
Our platform, the Pyramid, is designed to provide clinicians faster actionable results, without compromising accuracy, allowing molecular diagnostics to become part of the patient treatment pathway. About 70% of all patient actions taken relay on accurate laboratory results. Having them available in approximately 10 minutes reduces patient’s anxiety. Definitive results also help to prevent unnecessary and inaccurate antibiotic or their use which could lead to patient resistance.
Currently, it requires one to three hours to complete a single coronavirus test on existing laboratory equipment. The XCR® COVID-19 test reduces amplification and detection time to approximately 30 minutes, both reducing the time to make those critical quarantine decisions and allowing more test results to be produced on the same instrumentation in the same period.
When our Pyramid testing system becomes commercially available, results will be available in as little as 10 minutes. The Pyramid is a compact, portable instrument capable of being operated anywhere testing is needed; even using battery power if electricity is limited. The other advantage this portability creates is eliminating the need to transport samples to a hospital or commercial laboratory. In the case of mobile sample collection sites, results could be reported to the clinician and/or patient before they arrive home.
The verification and validation work required to submit the XCR® COVID-19 test to the FDA for Emergency Use Authorization has been completed and we will submit to the FDA.
XCR is focused on infectious disease now, but plans to partner with others to expand into women’s health, oncology diagnostics, both screening and monitoring, and human sequencing. We plan to expand assays using this technology until it becomes the Gold Standard for next generation nucleic acid testing.
The device was designed for portability. It has a replaceable battery which eliminates the time for sample transport, speeding up patient result analysis. The system can be used in physician’s offices, clinics, cruise ships, remote field applications: virtually anywhere.
The system automates and minimizes the number of manual steps which could cause user errors. There are three simple steps an operator is required to do:
- Collect the patent sample
- Insert the patent sample into a single use cartridge
- Place the cartridge into the instrument
There are two possible ways we can implement rapid nucleic acid testing:
- Our technical staff can convert a laboratory’s current PCR assays into the XCR format for use on their PCR instrumentation, or
- When commercially available, a Pyramid system can be ordered and placed in any location where testing is needed.
The Pyramid is designed to offer CLIA waived tests, so implementation and training is also easy and can be accomplished through a self-training program or a visit from our technical staff.
70-80% of patient action is a result of laboratory tests. We can change the paradigm on patient treatment by providing the right test with faster, more timely results allowing clinicians to prescribe the right medication sooner and minimize overprescribing.
XCR has a two-pronged approach. Laboratories can utilize our Xtreme Chain Reaction (XCR®) technology with traditional PCR systems, as noted by our newest patent approval by the US Patent Office, which cuts traditional PCR time to result by greater than 50%. This means a laboratory can significantly increase their test volume and improve result turn-around-time.
We have also developed a small, portable system, the Pyramid, which can produce results in approximately 10 minutes to a negative result. A positive result is more rapid. This approach allows true near patient or Point of Care, testing. The Pyramid can function on its own battery or be plugged into a wall outlet.
At this time, the earliest the virus can reliably be detected after infection is not known. However, there is report in the New England Journal of Medicine that shows, using nucleic acid amplification, that the virus can be detected in less than 3 days after onset of symptoms in many patients. This window will likely become smaller as more data becomes available.
Our assay isolates the patent’s DNA or RNA, known as nucleic acid, then in about 4 to 6 minutes replicates its billions of times so the Pyramid can detect a positive result. DNA and RNA assays multiply the genetic code of the bacteria or virus, in this case the virus COVID-19, enabling detection of extremely minute amounts of the virus.
We have developed the assay for use on commercially available platforms, instruments that are already in laboratories and hospitals. We are currently are verifying the test performance. Once verification is complete, in the next few weeks, we plan on engaging the FDA to request an Emergency Use Authorization (EUA).
We will be attending the ASM Clinical Virology Symposium May 3-6 in West Palm Beach, FL, Booth 525. We will be demonstrating the Pyramid and be sharing clinical patient data.
Our focus is on completing our COVID-19 work, beginning our first FDA clinical trail later this year and commercializing the Company throughout 2021.