RTP-based BioMedomics seeks FDA OK for ’emergency use’ of its coronavirus test
RESEARCH TRIANGLE PARK – BioMedomics, a medical diagnostic company based in RTP, has submitted an application to the FDA seeking emergency use authorization for the antibody test kit in the United States.
Frank Wang, Ph.D., chief executive officer of BioMedomics, said he doesn’t know if or when the test will be approved for sale but said it’s important to get the test on the market immediately to help stem the spread of COVID-19.
“In an outbreak, you need a fast (diagnostic) answer to isolate people,” he said. “Now is the time to deploy this. We need to get it onto the market as soon as possible.”
The FDA and the U.S. Centers for Disease Control and Prevention have been scrambling to respond to the COVID-19 crisis, and the CDC has had problems with the accuracy and quantity of the initial PCR-based test kits it sent to health departments across the country.
BioMedomics has developed a new test for rapidly detecting COVID-19, the coronavirus infection that is spreading rapidly throughout the world.
The company is working overtime to deploy its COVID-19 IgM-IgG Rapid Test, an immunoassay that can yield results from a blood sample in 15 minutes at the point of care. It uses proprietary antibodies to detect two proteins, immunoglobulin M and G, that are produced by the body’s immune response to the virus.
Another company test, COVID-19 PCR Virus Detection Kit, uses polymerase chain reaction (PCR), a method for amplifying small amounts of DNA for analysis, and a genetic probe to identify the coronavirus’ genetic signature. Tissue samples taken from a nasal or throat swab are tested in a lab.
Used in combination, the two tests could give health care providers a comprehensive solution for detecting the virus accurately, reducing the chance of misdiagnosis, the company said.
“BioMedomics’ integrated solution, which uses both PCR and antibody tests, can meet the detection needs for both early- and late-stage disease prevention, control and monitoring,” Wang said. “Our kits provide a high-quality, multi-dimensional and cost-effective solution for disease-control departments and medical institutions.”
The PCR test can be used before antibodies are generated in the later stages of infection, Wang explained. After antibodies appear, the antibody test can be used for more efficient diagnosis.
Combining both PCR testing and antibody testing ensures patients at every stage of COVID-19 infection can be diagnosed, Wang said.
The antibody test can be used to screen carriers of the virus regardless of whether they are showing symptoms of COVID-19 infection. Its ease of use and rapid results make it suitable for use by businesses, schools, airports, seaports and train stations, in addition to hospitals, clinics and test laboratories, Wang said.
TEST NOT YET AVAILABLE IN U.S.
The antibody test is being used widely by researchers in several countries and by China’s Centers for Disease Control and Prevention to combat infections in that country. More than half a million test kits have been sold in China, and the number is growing daily, Wang said. BioMedomics has a subsidiary in China that is manufacturing and distributing the kits there.
The test recently received CE Mark-IVD certification for use in Europe and is being sold in Italy, the world’s current hot spot for the outbreak.
However, the test has not been approved by the U.S. Food and Drug Administration for use in the United States.
Wang has been sleeping only four to five hours a night as BioMedomics works overtime to make the company’s antibody tests available as widely as possible.
“This is a crazy situation,” he said. “We’re moving very quickly.”
This week his company hired six temporary workers to handle the logistics of growing test kit sales outside the United States. They are answering a flood of emails, processing invoices and arranging shipments of the test, which is now being sold in multiple countries in Asia, the Middle East and Europe.
“We have a lot of sales activity outside the U.S.,” Wang said.
The antibody test was developed by the company’s research and development team as the virus started to spread in China. COVID-19 emerged in that country and has swept around the world rapidly due to global travel and a shortage of test kits for early diagnosis.
A scientific paper describing BioMedomics’ antibody test and its performance on COVID-19 patient samples has been peer reviewed and accepted for publication by the Journal of Medical Virology. The paper reports the test was highly sensitive and specific when used on blood samples from 397 confirmed COVID-19 patients and 128 negative patients at eight different clinical sites.
As of March 12, more than 1,300 cases of COVID-19 and 38 deaths had been reported in the U.S. Worldwide, more than 81,000 cases and 3,162 deaths had been confirmed by the World Health Organization as of March 11, qualifying the infection as a global pandemic.
Symptoms of COVID-19 include fever, a dry cough, fatigue and difficulty breathing. In otherwise healthy people, the infection can be mild, but for the elderly or those with underlying health problems, it can lead to pneumonia and death.
COMPANY SUPPORTED BY NCBIOTECH
BioMedomics was founded in 2006 to develop innovative point-of-care diagnostic solutions for underserved diseases and populations around the world. A $19,000 loan from the Biotech Center supported the start-up.
A $250,000 Small Business Research Loan in 2016 supported the company’s development of a low-cost, rapid point-of-care test for sickle cell disease, an inherited blood disorder. That test is now marketed as Sickle SCAN, an immunoassay that can distinguish between normal, carrier, and sickle cell disease samples within five minutes.
The company also markets Fungi SCAN, a reagent used in processing samples for the detection of fungal infections, and Femi SCAN, a staining agent used in the diagnosis of vaginal infections.