Scanwell secures exclusive rights to license China FDA-cleared rapid serology test from INNOVITA; Partners with nationwide telehealth provider Lemonaid Health to distribute smartphone-enabled tests to individuals in the U.S.
Scanwell secures exclusive rights to license China FDA-cleared rapid serology test from INNOVITA; Partners with nationwide telehealth provider Lemonaid Health to distribute smartphone-enabled tests to individuals in the U.S.
LOS ANGELES, March 19, 2020 /PRNewswire/ -- Scanwell Health, a developer of smartphone-enabled, at-home diagnostics, announced today that it has secured exclusive rights to license and distribute a SARS-CoV-2 rapid serology test from INNOVITA for at-home use. The test takes 15 minutes to complete using the Scanwell Health app, and within hours a doctor or nurse practitioner will reach out with results and next steps.
This type of test can be used to identify large numbers of infected patients and asymptomatic carriers, ultimately supporting containment efforts and slowing the spread of the virus. Currently, the test is the only rapid serology test cleared by China’s FDA, the National Medical Products Administration (NMPA), that detects and displays both IgM and IgG antibodies in the blood. To distribute the tests to individuals in the U.S., Scanwell will leverage its existing partnership with telehealth partner Lemonaid Health.
The SARS-CoV-2 test is manufactured by the Chinese biotechnology company INNOVITA and has been used extensively in China for aiding in the diagnosis of COVID-19. The test detects IgM and IgG antibodies against novel coronavirus SARS-CoV-2 in the blood, which indicates that a person has been exposed and developed antibodies against the virus.
“We recognized that a number of healthcare organizations are struggling to evaluate patients for COVID-19 due to testing constraints,” said Stephen Chen, Founder and CEO of Scanwell Health. “While the gold standard for diagnosis is still the PCR test, given the growing shortage of swabs and reagents, a rapid serology test is beneficial in that it allows for wide-scale testing.”
“We hope that these home-use test kits will ease the burden on healthcare centers, so that they can focus on the highest severity cases,” added Chen.
How the Scanwell Health SARS-CoV-2 Rapid Test will work:
- Patient completes online intake questionnaire to be evaluated by a Lemonaid doctor or nurse practitioner.
- If appropriate, the Lemonaid doctor or nurse practitioner will order a test for the patient (following guidelines established by the CDC) and an at-home test kit will be mailed out to the patient via next business day delivery.
- Once received, patient performs at-home test and securely shares results with a doctor or nurse practitioner via the Scanwell app. This process takes 15 minutes, and the patient can expect to hear back from the doctor or nurse practitioner within hours.
- Patient receives follow-up consultation with a Lemonaid doctor or nurse practitioner, who will advise on next steps (self-quarantine, confirmatory testing, in-person care, etc.).
The clinical trial of the IgM and IgG rapid serology test for SARS-CoV-2 from five institutions in China demonstrated 87.3% sensitivity and 100% specificity when compared to traditional tests. Though the presence of IgM and IgG antibodies can take time to develop, antibody tests are especially helpful for tracking the spread of the virus as they also identify asymptomatic carriers (the World Health Organization reports that 80% of infections are mild or asymptomatic) and those who may have been previously infected.
While U.S. protocols for COVID-19 testing have been initially limited to PCR tests, the FDA on 3/16/2020 updated its guidance to include the use of serological tests.
“The advantage of collaborating with INNOVITA is that they have firsthand clinical data showing how effective their IgM and IgG tests have been in managing disease outbreak in China,” said Chen. “Furthermore, making this test available to U.S. patients in the home via Lemonaid Health will allow patients to receive personalized guidance from a doctor or nurse practitioner in a safe environment while limiting exposure.”
“The option of having an at-home test mailed next day to your door gives Americans nationally a new option for how to get tested without putting others at risk of infection by driving to a lab or doctor’s office,” said Paul Johnson, CEO and co-founder of Lemonaid Health. “Our medical team will order the test, convey the results to the patient, and help the patient understand what the test result means in terms of both the result and what to do next. The result of the test could have immediate implications for not just the patient, but their family and friends, too.”
Scanwell is anticipating that the SARS-CoV-2 rapid test kits will be available within 6 to 8 weeks after Scanwell obtains Emergency Use Authorization (EUA) from the FDA for at-home use of serology tests. The service will be provided at cost ($70 including next business day delivery, no insurance required), and will first rollout in WA, CA, NY and other severely affected states. Scanwell is investigating options to provide the service for free to patients unable to pay. For more information, please visit www.lemonxscan.com.
About INNOVITA
Established in 2006 in Beijing, Innovita Biological Technology Co., Ltd. is a Chinese high-tech enterprise specialized in R&D, manufacturing, marketing and after-sales service of In-vitro diagnostic tests. Learn more at http://www.innovita.com.cn.
About Lemonaid Health
Lemonaid Health is leading the next wave of telemedicine innovation and medicine delivery. We use clinical algorithms to augment our physician’s knowledge as the basis for our platform that enables patients to quickly, safely and inexpensively get care and prescriptions for a variety of common medical conditions. Our mail order pharmacy typically mails medicine same day. Our medical team, website and mobile app have garnered an industry-leading Net Promoter Score of 89 and our telehealth practice has processed hundreds of thousands of visits nationally. Learn more at lemonaidhealth.com.
About Scanwell Health
Scanwell Health makes healthcare more accessible through smartphone-enabled, at-home diagnostics. Scanwell’s innovative approach lets people test from anywhere, skip the waiting room and get same-day results. By quickly diagnosing acute illnesses, chronic diseases and rare conditions, Scanwell accelerates the path to treatment. The company’s first offering is the only FDA-cleared over-the-counter app that provides testing and treatment for urinary tract infections (UTIs). Other solutions will follow in 2020. Learn more at scanwellhealth.com.
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SOURCE Scanwell Health
