Focus Diagnostics Launches Laboratory Test for Chikungunya Virus

Focus Diagnostics, Inc., the infectious disease diagnostics company of Quest Diagnostics, today announced the first laboratory developed test in the U.S. for detecting the mosquito-borne chikungunya virus.

Commercial availability of the molecular polymerase chain reaction (PCR) test will enable physicians in the U.S. to test patients who may have contracted the virus, such as individuals returning from regions in Africa and Asia where chikungunya is endemic. The U.S. Centers for Disease Control and Prevention (CDC) has suggested that the chikungunya virus, which caused an outbreak in Italy in 2007, has the potential to enter and spread in the U.S.

"The availability of our chikungunya virus PCR test will give healthcare providers in the U.S. an important option for identifying patients, particularly travelers, who may be infected with this potentially disabling virus," said Dr. Jay M. Lieberman, medical director, Infectious Diseases, Focus Diagnostics. "In recent years, Focus Diagnostics has brought to market new diagnostic tests that physicians can use to diagnose emerging infectious diseases, such as West Nile Virus and SARS. If chikungunya emerges in the U.S., our test could become an important tool to help mobilize an effective public health response. Chikungunya is a challenge to diagnose because its symptoms can mimic those of other diseases, including other mosquito-borne diseases, so the availability of an accurate diagnostic test is essential to minimize spread of the disease."

The chikungunya virus test is a molecular assay that employs PCR, a highly sensitive and commonly used testing method that can detect the presence of the virus' RNA in a patient's blood. Physicians can use test results in conjunction with clinical symptoms to diagnose a patient's infection with the virus. Until now, testing for chikungunya virus was not commercially available in the U.S. and specimens were referred to a public health laboratory, which could take a week or more to report results. Focus Diagnostics expects to be able to provide physicians with test results within a day of receiving a sample for testing.

Chikungunya's symptoms include fever, rash and joint pain, as well as headache, fatigue, nausea, vomiting and muscle pain. Death from the disease is rare, but long-term health effects can include disabling joint pain that persists for weeks or months. There is no vaccine or antiviral treatment for the disease.

In recent years, chikungunya has exhibited potential to spread to new regions. The CDC has reported that some travelers who visited India during an epidemic in 2006 that affected approximately 1.25 million individuals returned to the U.S. infected with the virus. The World Health Organization (WHO) has indicated that the emergence of chikungunya in Italy's northeast region of Ravenna in 2007 -- the first occasion that the Aedes albopictus mosquito had been involved in an outbreak of human illness in Europe -- has shown that "the spread of chikungunya across continents cannot be ruled out."

Chikungunya, which was first identified in Tanzania in 1953, is endemic in parts of Africa and Asia. The chikungunya virus is transmitted to humans through the bite of an infected mosquito. The Aedes albopictus mosquito, also known as the Asian tiger mosquito, was the primary carrier of the virus in the recent outbreak in Italy. The Asian tiger mosquito population has increased in the U.S. and is now commonly found in southern and eastern regions of the country. Another Aedes mosquito, A. aegypti, is responsible for outbreaks in Asia and Africa, and also is found in the U.S., primarily in southern states.

A leader in diagnostic testing for emerging infectious diseases, Focus Diagnostics has collaborated with the CDC, the WHO and other public health agencies to help identify and develop diagnostic tests for emerging infectious diseases. Focus Diagnostics was instrumental in developing the first laboratory developed test for West Nile Virus after it was identified in New York in 1999. Focus Diagnostics also introduced the first laboratory developed test for SARS and the first FDA-cleared serological test kit for Lyme disease.