Spartan’s COVID-19 test recall illustrates challenges of rapid medical device approval

Following the announcement that Spartan Bioscience has recalled its rapid COVID-19 test due to concerns by Health Canada;

Azadeh Laffafian PhD, Medical Device Analyst at GlobalData, a leading data and analytics company, offers her view:

“Recall of Spartan’s COVID-19 test is not surprising as extraordinary circumstances have accelerated the approval of medical devices. While fast tracking of medical products needed to address COVID-19 is important, it is also imperative that proper screening and quality assurance take place.

“Spartan’s test kit was approved by Health Canada in April in an expedited fashion. However, in early May, the test was recalled due to concerns regarding efficacy of its proprietary swab raised by Health Canada. Spartan is currently working on addressing concerns and is hoping to quickly bring the product to market.

“If Spartan is able to quickly address current concerns and no other issues arise, it is likely that the test kit will be highly utilized in Canada. Canadian provinces are hoping to continue to increase testing and new qualified tests are welcomed. Additionally, the kit’s portable and rapid nature makes it an attractive product. The test can be performed in settings such as airports and doctor’s offices by non-laboratory personnel. This is especially helpful for rural and remote areas where access to testing laboratories is limited.

“If Spartan’s tests are successful in Canada and the company is able to ramp up enough production, it is likely that the kit will also be exported, as the company had previously indicated a global interest in its product.”

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