FDA Gives Authorization To Framingham Company To Sell At-Home COVID Testing Kit

FRAMINGHAM – The Food & Drug Administration (FDA) has given authorization to a Framingham company to sell at-home COVID-19 testing kits under an emergency order.

The EmpowerDx, located at 175 Crossing Blvd in Framingham, would sell a kit that allow “Individuals to self-collect nasal swabs at home, when determined by a healthcare provider to be appropriate based on the results of an online COVID-19 questionnaire, and for use only with in vitro diagnostic (IVD) molecular tests for the detection of SARS-CoV-2 RNA.”

The product is a collection kit intended for use by individuals to self-collect nasal swabs (unsupervised) at home, when determined by a healthcare provider to be appropriate based on the results of an online COVID-19 questionnaire.

Once collected, the nasal swab specimen, which may include SARS-CoV-2 RNA, is maintained in the authorized product packaging and transported at ambient temperature to an authorized laboratory.

The authorized laboratory then 4 runs the specimen using an IVD molecular test that is indicated for use with nasal swab specimens collected with the EmpowerDX At-Home COVID-19 PCR Test Kit.

When using your product, individuals must follow all specimen collection and mailing instructions provided with the kit.

The EmpowerDX At-Home COVID-19 PCR Test Kit includes the following materials or other authorized materials: user sample collection instructions (described below), polyester nasal swab, collection tube containing 0.9% buffered saline, tube label, biohazard bag with absorbent pad, FedEx return shipping box/envelope prelabeled with the receiving laboratory delivery address.

The FDA concluded in mid-October “pursuant to Section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that your product may be effective in diagnosing COVID-19 by serving as an appropriate means to collect and transport human specimens so that an authorized laboratory can detect SARS-CoV-2 RNA from the self-collected human specimen when used consistent with the Scope of Authorization of this letter (Section II), pursuant to Section 564(c)(2)(A) of the Act.