FDA Approves Commercial Zika Test, & That Means Getting Tested Will Be So Much Easier
One of the major challenges in the battle to contain the outbreak of the Zika virus has been access to proper testing — or really, the lack of access. Patients concerned they could be affected by the Zika virus had to jump through a few hoops and suffer delays in the process as only government labs were approved to carry out tests, and doctors had to go through local and state health departments. Now that the FDA has approved commercial testing of the Zika virus, the process could become significantly more streamlined.
Quest Diagnostics became the first company to win emergency use authorization for their test to diagnose the Zika virus from the FDA on Thursday. Which is especially good news for pregnant women, considering the Center For Disease Control And Prevention recommends pregnant women get tested for the virus if they are experiencing Zika-related symptoms like fever, rash, joint pain, and conjunctivitis; have traveled to a known Zika-infected area while pregnant; have had sex with someone who could have been exposed to the Zika virus.
The new FDA-approved test created by Quest Diagnostics will be made available to doctors for $500, and results from the test are reportedly available after three to five days. The company relies on its own refrigerated vans for quick, secure shipment of the blood tests to and from the airport.
Quest released a statement on Thursday about where the test will be available:
Currently, the only laboratory that will use the new Zika test is at Quest's reference laboratory in San Juan Capistrano, California, where the test was developed and validated. But the Emergency Use Authorization may allow for testing at other qualified laboratories, including one in Puerto Rico.
As for the cost of the test, a Quest spokeswoman said:
We expect most patients to be in a health plan and may therefore receive some coverage benefits depending on the type of health plan, region and other factors. We also offer an uninsured patient price of $120 for patients who lack health insurance and whose providers have verified their patient is eligible.
While this is great news for patients who need better access to testing, it is important to remember that the tests are not foolproof. This test will only be able to detect the Zika virus in the blood sample if the patient is currently infected; it won't be able to detect previous infections.
With the Zika virus spreading and new research confirming that the Zika fever could be directly linked to Guillane-Barre Syndrome (a neurological disease that causes rapid paralysis in the victim), better testing clearly could not come soon enough.