A test that takes only 20 minutes to reveal whether a person has Ebola will receive as much as $10.4 million in funding from the federal government, which said it could improve efforts to fight the spread of the deadly disease.
The U.S. Health and Human Services Department also said it will award almost $30 million in the next several years to fund what will be nine special regional treatment centers in the United States for patients with Ebola and other highly infectious diseases. (Tweet This)
Clinical funding for the rapid Ebola test, made by Pennsylvania-based OraSure Technologies, comes as the number of Ebola cases in the West African countries of Guinea and Sierra has experienced an uptick after seeing declines in recent months. The current Ebola outbreak, concentrated primarily in West Africa, is the worst on record, with more than 31,000 cases either confirmed, probable or suspected cases, and more than 12,600 deaths.
OraSure's product, called OraQuick Ebola Rapid Antigen Test, relies on either a finger-stick blood sample or a saliva sample. The company already has rapid tests for HIV and hepatitis C on the market.
"It works just like a pregnancy test," OraSure CEO Doug Michels told CNBC.com. "We began developing this product back in October, and this has been on a really aggressive and compressed timeline."
In addition to being used in a health-care facility, the OraQuick test for Ebola can also be performed in the field, which could greatly reduce the lag in getting results. Current Ebola tests, which rely on blood drawn from a person, can take several hours to produce results. But the outcome can sometimes take days because of the time it takes to transport the sample to a lab.
OraQuick also doesn't require refrigeration of samples, which most of the lab-based tests demand, and which is a challenge in poor countries, Michels said.
The OraQuick test may also end up being used on people who have died to determine if Ebola killed them. That application "could be very beneficial" to countries like ones in West Africa where there are traditions of laying hands on the dead to prepare them for burial, Michels said. That practice that has been blamed for increasing the spread of Ebola there because even after death, bodies are highly infectious to those around them.
"Fast and inexpensive point-of-care diagnostics will improve our ability to control the Ebola virus disease outbreak," said Robin Robinson, director of the federal Biomedical Advanced Research and Development Authority. "Faster diagnosis of Ebola virus infections allows for more immediate treatment and an earlier response to protect public health worldwide."
BARDA is overseeing the development program of the test for the Health and Human Services Department.
While the OraSure test is the first "point-of-care" Ebola test to receive funding from BARDA, there are other rapid Ebola tests. One from Colorado-based Corgenix Medical received funding from the Bill & Melinda Gates Foundation and the Paul G. Allen Foundation. Another quick test has been produced German drugmaker Stada and a third by British military scientists and the National Health Service in the United Kingdom.
OraSure will initially receive $1.8 million under the HHS contract. Over the next 39 months, the company could receive a total of up to $10.4 million as it works to obtain Food and Drug Administration approval.
OraSure expects the FDA to grant the company emergency authorization "in the next month or two" to begin selling the OraQuick Ebola test to governmental organizations that have been fighting the virus as well as to international aid agencies, Michels said. Such authorization would allow the test to be used overseas. Corgenix's ReEBOV received such authorization in March.
Afterward, OraSure will seek FDA approval for sale of the test in the U.S. to doctors or hospitals.
Michels declined to say how much the Ebola test would cost. But OraSure's HIV test, which uses the same technology, sells for $12 per use to health professionals.
The company's HIV test is the only such test for that AIDS-causing virus to be approved for sale directly to consumers, and is marketed through more than 30,000 pharmacies. It sells for $39 over the counter.
Also Friday, HHS selected nine health departments and associated partner hospitals to become special regional treatment centers for patients with Ebola or other severe, highly infectious diseases.
HHS awarded about $20 million to bolster those treatment centers' ability to care for people with Ebola and other diseases. Another $9 million will be given to the centers in the next four years.
"This approach recognizes that being ready to treat severe, highly infectious diseases, including Ebola, is vital to our nation's health security," said Dr. Nicole Lurie, HHS assistant secretary for preparedness and response.
The regional facilities are part of a national network of 55 Ebola treatment centers, and will "have enhanced capabilities to treat a patient with confirmed Ebola or other highly infectious disease."
"Even with the establishment of the nine regional facilities, the other 46 Ebola treatment centers and their associated health departments will remain ready and may be called upon to handle one or more simultaneous clusters of patients," HHS said.
The nine awardees are Massachusetts Department of Public Health in partnership with Massachusetts General Hospital in Boston; New York City Department of Health and Mental Hygiene in partnership with New York City Health and Hospitals Corporation/HHC Bellevue Hospital Center; Maryland Department of Health and Mental Hygiene in partnership with Johns Hopkins Hospital in Baltimore; Georgia Department of Public Health in partnership with Emory University Hospital and Children's Healthcare of Atlanta/Egleston Children's Hospital in Atlanta; Minnesota Department of Health in partnership with the University of Minnesota Medical Center in Minneapolis; Texas Department of State Health Services in partnership with the University of Texas Medical Branch at Galveston in Galveston, Texas; Nebraska Department of Health and Human Services in partnership with Nebraska Medicine - Nebraska Medical Center in Omaha, Nebraska; Colorado Department of Public Health and Environment in partnership with Denver Health Medical Center; Washington State Department of Health in partnership with Providence Sacred Heart Medical Center and Children's Hospital in Spokane, Washington.