Spartan’s Covid-19 test recall in Canada illustrates the challenges surrounding rapid medical device approvals, says an analyst.
The Ontario-based biotech firm received accelerated approval for its rapid coronavirus testing kit in April — but has voluntarily recalled the product after regulatory body Health Canada expressed concerns over the efficacy of the test kit.
Dr Azadeh Laffafian, a medical device expert at analytics firm GlobalData, said this recall is “not surprising” due to the extraordinary circumstances under which devices are being fast-tracked through regulatory frameworks.
Laffafian said: “While the fast-tracking of medical products to address Covid-19 is important, it is also imperative that proper screening and quality assurance takes 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.
“Spartan is currently working on addressing these concerns and is hoping to quickly bring the product to market.”
Spartan Covid-19 test
Spartan’s test for diagnosing Covid-19 involves taking a DNA sample from a patient using a swab.
The sample is placed in a cartridge, and then inserted into a Spartan Cube — a handheld, portable DNA analyser that can detect whether the virus is present and can produce results in less than one hour.
The test, which had already received a CE mark for use in Europe as an IVD (in vitro diagnostic) medical device, was also approved by Health Canada on 13 April.
Following a $9.5m deal with Alberta Health Services (AHS) — the major governmental health authority in Alberta — 100,000 of Spartan’s testing kits, as well as 250 Spartan Cubes, were set to be rolled out in rural areas of the province.
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The Spartan Cube is a DNA analyser capable of detecting Covid-19 in less than one hour (Credit: Spartan) But this plan was called off in early May, and the firm chose to recall all 5,500 of the products it had already shipped out nationally, after Health Canada raised concerns over the efficacy of the proprietary swab used to take DNA samples from patients in the test.
As reported online by Canada’s National Observer, Dr Theresa Tam — the country’s chief public health officer — told a news conference on 3 May that problems with the Spartan test had emerged during “real-world trials”.
What next for the Spartan test?
In a recent statement, Spartan said it is now performing additional clinical studies to assess the sampling method — and the proprietary swab — used in its Covid-19 test.
It also said that, despite raising issues over the swab tool, the Health Canada report indicated no concerns regarding the accuracy or analytical performance of the Spartan test’s reagents, or the portable DNA analyser involved.
The company is now working “as quickly as possible” to address the concerns raised by Health Canada, and still fully intends to take its coronavirus testing kit to the commercial market.
Laffafian said: “If Spartan is able to quickly address current concerns — and no other issues arise — it is likely that the test kit will be highly utilised in Canada.
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Canadian prime minister Justin Trudeau announced plans to shorten device applications and speed up approvals in March (Credit: Steve Jurvetson) “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, which 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.”
Health Canada said Spartan’s product has been restricted to “research use only” until substantial evidence of its clinical performance has been provided.
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