Vigilant Diagnostics is in the advanced stages of developing Point-of-Care Instrument (PCI) products that will provide early clinical detection for a variety of infectious diseases. These products include digital readers that can distinguish a positive result faster and provide much more sensitivity per test than the human eye. A lab desktop version of the reader has been under development and refinement by the company for several years, and a handheld, consumer version is now also being developed.
Longer term, Vigilant Diagnostics will also develop and market its own LFA tests to detect Flu, Strep, HIV, and other infectious diseases under its own brand name or others.
How Our PCI Products (Readers) Work
The user swabs either the sinus area or the back of the throat and then places the specimen sample in a liquid, which is transferred to a sample area of a Lateral Flow Assay (LFA) test strip. The user inserts the cartridge with the test strip into the reader and presses a button to start the test. The reader then holds the cartridge for the appropriate incubation time and automatically scans the slide sample with a laser. Then, the sample will return a unique thermal signature specific to the type of microorganism on the slide, while providing a semi-quantitative or quantitative response for the test result.
Vigilant Diagnostics products promise a significant breakthrough in the early detection of a Flu or Strep infection (just for two disease examples), rapidly informing the patients and leading to a treatment of choice more quickly. For example, at the first sign of the symptoms of a cold or flu, the consumer will be able to swab and test themselves or a family member and, within minutes, know if the person being tested (child, spouse, parent, grandparent) has a flu virus or just a common cold. If it is the flu, the patient can take immediate action by consuming an antiviral product such as Tamiflu, which can greatly reduce the severity of an influenza infection. In the case of young or elderly patients, this can be a lifesaving decision. Conversely, if the patient just has a common cold, they should not take a flu-targeted medication, but instead just follow the usual symptom-relief measures provided by over-the-counter medications.
Similarly, if someone has a sore throat, they will be able to determine with a Vigilant Diagnostics consumer test kit and reader if it is the streptococcus bacteria. If so, they can immediately begin appropriate treatment with antibiotics, as the results of the test can be transmitted to their physician. He or she can then write a prescription and send it to the pharmacy, who in turn could deliver the Rx to the user. If it is not a strep infection, the patient would be able to avoid using unneeded antibiotics.
Privacy concerns are often the reason people in the at-risk population for HIV hesitate to get tested. The complete privacy afforded by Vigilant Diagnostics testing for HIV is inherently obvious and will make a crucial contribution in preventing the spread of the infection, and for commencing immediate treatment.
Screening for the COVID-19 novel coronavirus is a more acute and much larger issue for infectious disease detection. The primary strategy for controlling the spread of the disease is to be able to either 1) isolate or quarantine large groups of people, or 2) be able to screen them at multiple disparate locations so that they can be kept separate from people who don’t have the disease. Being able to do so rapidly, with a high degree of sensitivity and accuracy, is paramount for maintaining containment.
The PCI products (readers) being developed by Vigilant Diagnostics provide an advanced level of performance and accuracy, far exceeding other diagnostic testing methodologies. Early versions of the company’s readers have been used in clinical studies and evaluations with strategic partner firms, with excellent results. (See “Published Papers” on Technology page.)
In summary, Vigilant Diagnostics has made significant progress and improvements in Lateral Flow Assay (LFA) instrumentation. The company’s readers feature its patented Thermal Contrast Amplification technology and can be used for testing with available LFAs.
The desktop laboratory reader has undergone significant reliability improvements and has been utilized by strategic partner firms to evaluate the technology with their products. In addition, it has been the key instrument used in testing Flu and Strep A samples for the company’s STTR NIH grant, along with testing in newer Centers for Disease Control (CDC) HIV studies.
A smaller, handheld reader currently in development will feature its own user interface and will have less expensive components. It will be a sub-$1000 device intended for consumer, in-home use. Early results with prototypes of this reader have been shown to be comparable to the larger instrument.
From the experience gained with the development of these products, Vigilant Diagnostics is now moving rapidly toward commercial release of its desktop reader for physician’s offices (as shown above), working with an established engineering and manufacturing firm. Shipments to early strategic partners are expected to start in late 2020, with customer revenue beginning in 2021..
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