What you need to know about Fulgent Genetic testing

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Daily file photo by Zoe Malin

At at-home test kit from Picture Genetics. All students were mailed a swab test and required to send it by the last week of August.

Marissa Martinez and James Pollard

Northwestern announced its new, free testing program August 19, which will begin with a three-step process for all undergraduate students returning to campus. The first part involves an at-home test mailed to students prior to campus arrival, due August 27 — ten days before students will start to move in during the Wildcat Wellness period.

The testing will be conducted by a third party, Fulgent Genetics, which is based in Temple City, Calif. The Food and Drug Administration authorized Fulgent to administer COVID-19 by RT-PCR home tests this spring. According to their website, the accredited company’s primary focus is offering “flexible and accessible” genetic testing. Because the company was already performing at-home medical testing before the pandemic, providing COVID-19 genetic testing was  the “logical next step,” a statement on its website says .

Ordering tests is restricted to adults who have completed an eligibility screener. Students who are younger than 18 or live outside the United States are exempt from the requirement, according to Northwestern’s email

The test specifically deals with the presence or absence of SARS-CoV-2 nucleic acid, found using the nasal swab. It will then be reverse transcribed into cDNA. Some students have expressed concern about a genetics company conducting the tests, given the potential to share sensitive DNA information with third parties. While Picture Genetics examines human DNA in their other tests, the company says this particular test looks for genetic signatures of coronavirus instead. 

Neither Northwestern nor testing companies will disclose results outside of the University, testing service providers and “possibly governmental authorities and third parties to the extent required or permitted (including for contact tracing purposes) by law.” Families will not receive their adult student’s results.

Full instructions from the FDA can be found here. The steps specify FedEx receive the sample on the same day it is collected, and not mailed on the weekend, to ensure accuracy. Late samples may not be accepted. 

The agreement form signed by all returning students over 18 spells out a variety of terms, including the possibility of false positive or negative results, injury or less reliable results due to at-home testing limitations, and the potential release of information with local, state or federal public health agencies in accordance with applicable law.

It also states that Northwestern may require periodic re-testing, which would fall under this signed consent form. In exchange, the University will provide additional guidance about the consequences of participating in or not participating in this testing program before deciding whether to do so. 

The HIPAA agreement authorizes the transfer of and release of information, including self-provided medical history, test results and other health information collected by or in connection to Fulgent Genetics. Fulgent’s full HIPAA policy can be found here. The company stores personal information “for as long as we need it to provide you our Services,” according to their site. Questions on their policy can be directed to [email protected]

If a student’s test result is positive, they will be contacted by a medical provider associated with Picture Genetics to provide medical guidance if necessary. They would also have to self-isolate at home for up to two weeks before being cleared to return to campus by Health Services.

Email: [email protected], [email protected]

Twitter: @mar1ssamart1nez, @pamesjollard

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