- The new test diagnoses patients within hours of their doctor appointment
- FDA bypassed normal routes to approve the Swiss-made test on Monday
- It is the first conclusive test to detect the virus in patients in the US
Mia De Graaf For Dailymail.com
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Reuters
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Federal regulators have issued emergency authorization for a new Zika test that can detect the virus in just two hours.
The move to bypass normal approval channels comes amid a race to diagnose and treat the growing number of Americans contracting the mosquito-borne virus.
Developed by Swiss drugmaker Roche, the test allows doctors to quickly identify the infection in patients whose symptoms may not be conclusive.
The news, announced on Monday, comes after it emerged a Maryland man with no symptoms of Zika managed to pass the virus to his sexual partner after traveling to the Dominican Republic.
The move to bypass normal approval channels comes amid a race to diagnose and treat the growing number of Americans contracting the mosquito-borne virus (pictured)
Zika, detected in Brazil and elsewhere last year before spreading to the Americas, is associated with microcephaly, a birth defect characterized by an unusually small head and potential developmental problems.
As of last week, the United States had reported 2,517 Zika cases, 29 of which were likely acquired locally in Florida through mosquito bites.
The rest were brought in by travelers, according to the CDC.
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Some 9,000 additional cases have been reported in U.S. territories, including Puerto Rico.
With FDA approval, Roche’s test now can be used to screen patients exhibiting Zika symptoms that meet CDC criteria, including fever, rash, joint pain and red eyes.
Samples will be sent for analysis to specially-certified U.S. laboratories with the appropriate equipment, a Roche spokesman said.
‘The LightMix Zika test is an easy-to-use molecular diagnostic test that enables healthcare professionals to quickly detect the virus,’ said Uwe Oberlaender, the head of molecular diagnostics at Basel-based Roche.
The FDA issues such Emergency Use Authorization during public health emergencies, to quickly deploy unapproved medical products for as long as they are needed.
A patient has been diagnosed with the mosquito-borne infection in Pinellas County. The area just outside Tampa is 265 miles away from Miami on the other side of the peninsula
As Zika cases caused by local Aedes aegypti mosquitoes in Florida mount and travelers from elsewhere continue to arrive with the disease, the FDA last week recommend universal testing of donated blood across the United States.
In March, Roche won separate investigational approval from the FDA for its Cobas 6800/8800 testing system to be used to test blood at U.S. blood centers including in Puerto Rico, where about 1 percent of donated blood has so far tested positive for the virus.
In Brazil, Zika virus has been linked to more than 1,800 cases of microcephaly, and U.S. officials expect as many as 270 cases in Puerto Rico.
WHAT YOU NEED TO KNOW ABOUT ZIKA
WHAT IS ZIKA?
The Zika (ZEE’-ka) virus was first discovered in monkey in Uganda in 1947 – its name comes from the Zika forest where it was first discovered.
HOW IS IT SPREAD?
MOSQUITOES
It is typically transmitted through bites from the Aedes species of mosquitoes.
They are aggressive feeders, commonly biting multiple people in quick succession, fueling the spread of the virus.
They are most active during mid-morning and then again between late afternoon and nightfall.
SEX
Scientists have found Zika can be transmitted sexually – from both men and women.
Couples should abstain or wear condoms for eight weeks if either partner has traveled to a country with a Zika outbreak, regardless of whether they have symptoms.
MOTHER TO BABY
A mother can pass the virus to her unborn baby during pregnancy.
There are two ways this can happen: through the placenta, and through the amniotic sac.
Since the virus can live in the womb lining, there is a chance the baby can become infected during birth.
ARE THERE SYMPTOMS?
The majority of people infected with Zika virus will not experience symptoms.
Those that do, usually develop mild symptoms – fever, rash, joint pain, and red eyes – for no more than a week.
There is no specific treatment for the virus and there is currently no vaccine.
CAN THE SPREAD BE STOPPED?
Individuals can protect themselves from mosquito bites by using insect repellents.
They could also wear long sleeves and long pants – especially during daylight, when the mosquitoes tend to be most active, health officials say.
Eliminating breeding spots and controlling mosquito populations can help prevent the spread of the virus.
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