SQI Diagnostics Inc V.SQD.H

Is Antibody Rapid Test Still Eligible for EUA/ UPHN

[ResearchGuy]

I was doing some research trying to figure out at what stage SQI is with its application for its Rapid/ Home testing for Antibodies. I came across this and started to wonder if SQI's Home testing technology is even still eligible for emergency use application. If Someone can confirm that SQI is still able to apply under EUA/UPHN use much appreciated.

Table 1. Categories of COVID-19 medical devices that no longer have UPHN status

Device category*	Assessment date
Thermometers	2021-07-16
Ventilators	2021-07-16
Lab-based molecular tests that do not offer saliva or other unique sample types	2021-08-05
Point-of-care antigen and molecular tests that can only be used with nasopharyngeal swab samples	2021-08-05
Lab-based serology tests	2021-08-05

*IO approval may still be possible for devices listed in Table 1 if the applicant provides enough UPHN evidence for the device. Health Canada will consider the supporting evidence and inform the applicant of the decision taken as per our service standards.

The device categories listed in Table 1 only affect applications filed after the assessment date identified in the table. Applications that were submitted before that date and are still being processed or authorizations already issued under the IO before that date are not affected.

The Medical Devices Regulationspathway remains open for obtaining medical device establishment licences (Class I) and medical device licences (Class II to IV) for all types of medical devices. To obtain a medical device licence and medical device establishment licence under this pathway, see the following guidance documents:


Info from - https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/notice-devices-no-longer-urgent-public-health-need.html

[ResearchGuy]

I guess my post might have initiated a response and my instinct re the EUA application with the FDA was spot on. let's hope that this new phase doesn't drag on and that we don't have a negative reaction on the SP. 

[cleareye]

Hi ResearchGuy, You must have had your intuitive antenae working earlier this morning/last night because SQD issued news on that very topic this afternoon; what follows is the first few paragraphs:     SQI Diagnostics adjusts to FDA shift from at-home tests   2021-10-19 18:23 ET - News Release   Mr. Andrew Morris reports SQI DIAGNOSTICS INC. RESPONDS TO CHANGE

[ResearchGuy]

My Spidy senses was telling me to do some research. I hope we can still move forward in a positive direction and do well with this company as I am still a believer in the technology.