SEATTLE, April 14, 2020 /PRNewswire/ -- Pharmefex, Sync.MD and X-CELLSYSTEM, all U.S. companies based in the state of Washington, have formed an alliance to provide an urgently needed resource for our nation's ability to Open Our Country.
Being the first in the nation to design the full end-to-end system of getting people back to work, this alliance of forward-thinking companies just completed the comprehensive demonstration of our approach which can be used as a model for the entire country and beyond.
We call our integrated approach ImmuID. The program is designed to accelerate the speed at which large numbers of employees can safely return to work in confidence that they have already mounted an immune response to COVID-19.
ImmuID is a unique and proprietary system with three key differentiators:
- A risk assessment algorithm based on twenty-five years of public health experience in assuring the safety of donated blood
- A state-of-the-art test for the presence of antibodies to COVID-19
- A secure, HIPAA-compliant, user-friendly platform for storing and sharing test results and a certificate indicating immunity.
X-CELLSYSTEM Founder and CEO Linda S. Barnes notes, "We saw the need for adaptive and innovative approaches to the COVID-19 pandemic, helping our society get back to work, safely and responsibly."
"It is precisely those who have been exposed to the virus, and have developed immunity, who can protect vulnerable colleagues who are still at risk of infection. Our systematic risk-based approach can avoid a resurgence of COVID-19 cases until we have other, more robust tools, like a vaccine."
"We created the Sync.MD platform to solve critical issues our healthcare system faces daily in a variety of care coordination scenarios," said Eugene Luskin, CEO. "It is being used today by leading hospitals and physicians and is trusted by patients. The COVID-19 pandemic created an urgent need to apply our proprietary technology to support full and efficient flow of data on screening, antibody testing and certificate issuance. This alliance with X-CELLSYSTEM and Pharmefex brings together, with VYRTY's Sync.MD, all the elements required to help get our country back to work."
"Our mission at Pharmefex is to use our decades of experience in biological sciences and engineering to develop creative yet robust solutions to complex problems in a regulated environment. We are proud to play a role in helping our nation to re-emerge safely, quickly and efficiently," Said Ali Siahpush, President and Founder of Pharmefex.
The ImmuID process has the following steps.
1. Employers request that their employees volunteer to participate in completing a risk assessment protocol and, where results indicate appropriate, have blood drawn and analyzed. Costs are borne by the employer (potentially with support by public funding).
2. Employees can opt-in voluntarily following informed consent protocols. Participating employers guarantee that employees who decline to participate will not have their employment status adversely affected.
3. Participating employees agree to all terms and conditions and then complete a confidential electronic questionnaire that serves to assess likelihood of exposure to COVID-19. In instances where an individual's responses indicate a likelihood of current COVID-19 infection, that would trigger an immediate recommendation to check with the appropriate health care provider.
4. Following completion of the questionnaire, employees may be scheduled for a blood draw. Blood samples are analyzed for presence of antibodies that indicate immunity to COVID-19.
5. When the analyses of blood sample and questionnaire responses are complete, employees are sent the ImmuID Certificate via their smart phones, using the secure Sync-MD app. This will include a readily recognized visual symbol that the employee can hold up and show on the smart phone. Employees also have the option to send the detailed results to their health care provider via secure digital transmission. The employer also receives an ImmuID Certificate for consideration to return the employee to work. The ImmuID Certificate indicates that there is evidence of exposure to COVID-19 and that there is evidence of an immune response to the virus that causes the disease.
ImmuID enables employers to expedite return to work of employees without putting other employees, supervisors, vendors, customers, etc. at risk. ImmuID also provides employees with confidence that by returning to work they are not putting themselves or family members in jeopardy of becoming infected.
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- This test has not been reviewed by the FDA.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.