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Is this test approved by the FDA and recommended by the CDC?
Our CLIA-certified national lab provider offers The SARS-CoV-2 (COVID-19) test that uses the FDA Emergency Use Authorization (EUA) approved CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel, that’s intended for the detection of COVID-19 in individuals who meet CDC or public health criteria for COVID-19 testing.
It's important to note that:
1) This test has not been FDA cleared or approved
2) This test has been authorized by FDA under an EUA for use by authorized laboratories;
3) This test has been authorized only for the detection of nucleic acid from 2019-nCoV, not for any other viruses or pathogens, and;
4) This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of SARS-CoV-2 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
How is the imaware™ test administered?
imaware™’s testing for COVID-19 is administered with a swab that is inserted into the nostril to reach the nasopharyngeal region, from where cells are collected -- a process that can make self-collection difficult. A healthcare professional is sent to the patient’s home to administer the test, deliver the sample to the lab and return accurate, easy-to-understand results. An independent telemedicine clinician under the Wheel network reviews the results and reaches out to patients testing positive for the virus with care instructions.
How much does it cost?
The imaware™ remote screening and testing solution is $135. Patients pay the fee online at checkout, prior to requesting an at-home sample collection. All fees include the screening, on-site testing by a healthcare professional, sample processing, results and follow up by an independent telemedicine clinician if needed.
Why isn’t the test free?
Many municipalities, like Houston, are offering free drive through testing to meet the needs of the low-medium risk population. imaware™ is specifically intended for vulnerable, high-risk individuals. As of now, private testing is not being subsidized by the federal or state government. We are providing this solution at cost
How long does it take to get results?
Patients can expect test results back within 72 hours after a healthcare professional collects their test sample.
How is imaware™ different?
The imaware™ test is set apart from other at-home options by the lower margin for error, due to the test being administered by a healthcare professional. While other types of tests requiring blood or saliva samples are simpler to self-collect, self-collected COVID-19 swab tests are at a greater risk for inaccurate results.
imaware™ adds patient-centric care to the equation post diagnosis through its superior telemedicine consult, Wheel, to help patients navigate symptoms through to recovery.