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Health Canada pauses regulatory approval for COVID-19 rapid test – CBC.ca

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Health Canada is restricting the use of a made-in-Canada, rapid COVID-19 test created by Spartan Bioscience after the National Microbiology Lab found problems with the test that made it unreliable. 

“In light of the clinical results, Health Canada has placed conditions on the company’s authorization to restrict the use of the product to research use only until adequate evidence of clinical performance can be provided,” the federal agency said in an emailed statement sent to CBC, after the story was first reported by Le Journal de Montreal. 

“The Spartan product can continue to be used for research purposes only.”

The portable test was called a “game changer” by health officials because it reportedly could deliver on-location results in under 60 minutes. Further upgrades to the test made by the Ottawa-based company promised to reduce that time down to 30 minutes.

According to Spartan, Health Canada’s concerns stem from the efficacy of the swabs the testing unit uses — and not with the machine itself.

Issue with swabs

The company was first informed by Health Canada about the concerns on Friday.

“The same report indicated no concerns regarding the accuracy and analytical performance of Spartan’s test reagents and portable DNA analyzer device,” said a statement published on the company’s website.

The company said it has already shipped out 5,500 tests nationally, but said it’s voluntarily recalling the product to perform more clinical tests. Most of those units were delivered to the National Microbiology Lab.

“Spartan will be working as quickly as possible to address the concerns and bring its test to market,” the company said. 

Prime Minister Justin Trudeau and Chief Medical Officer Dr. Theresa Tam attend a news conference in Ottawa in May. Tam said the federal government had ordered 40,000 tests per month from Spartan. (Adrian Wyld/The Canadian Press)

The federal government had ordered 40,000 tests a month from Spartan.

“While the Spartan system, the device, performed very well in a laboratory setting — along the specification the manufacturer had provided — it was in the clinical setting, the real-life setting, where it didn’t perform well,” Dr. Theresa Tam, Canada’s chief public health officer, said during a news conference Sunday.  

Canada hopes to begin testing 60,000 people for the virus daily, and Tam said the setback wouldn’t affect that goal. 

She also said the clinical testing done with the Spartan cube wouldn’t have affected the actual diagnoses of any patients.

Dr. Howard Njoo, Canada’s deputy chief of public health, said at the same news conference that he hopes the company can make the necessary adjustments so it can be used in a clinical setting in the future.

Prime Minister Justin Trudeau said on Sunday that some setbacks are expected, given that the federal government has accelerated the approval process for a number of potentially life-saving devices.

“We’ve said from the very beginning, that in this unprecedented crisis we needed to move very, very quickly,” Trudeau said.

“When we do that quickly, there are going to be new facts that come in and situations that evolve that will require shifts in our postures…. Similarly, provinces will have to adjust to new realities and adjust to successes and challenges as they come up.”

Provinces react

Several provinces were planning to use Spartan’s portable testing kits. 

Quebec had ordered 200,000 tests, which were expected to be delivered on May 31. 

The $16-million purchase was conditional upon the approvals of Health Canada, the Public Health Agency of Canada and the National Microbiology Laboratory, the province’s ministry of health and social services said in an email.

Ontario had also placed an order for more than 900,000 of the kits.

WATCH: Chief Public Health Officer Dr. Theresa Tam talks about reopening Canada:

Part 3 of 3 of Rosemary Barton’s exclusive interview with Chief Public Health Officer Dr. Theresa Tam on the WHO’s response to COVID-19, reopening Canada and the personal stresses that come with her job. 11:55

“We are actively engaging with Heath Canada to obtain clarification,” Hayley Chazan, a spokesperson for Ontario Health Minister Christine Elliott, wrote in an email.

“Despite Ontario not yet having used the Spartan tests, we are a leader in Canada in daily testing volumes per capita and rank among the top globally.”

Alberta Health Services (AHS), which announced a $9.5-million contract with the company in late March, said in an email Sunday it had suspended its evaluation of the testing devices following concerns about the technology’s efficacy.

AHS said it had received only a small number of devices to date, and was working to validate them before any use in clinical settings. None of the kits have been deployed for use in Alberta, AHS said.

The company said that provinces have not yet paid in full for the tests they ordered, although some have made a 10 per cent down payment. Spartan said it plans to fulfil all its contractual obligations once the issue with the swab is fixed.

Peter Lin, CBC News medical contributor and family physician, called the setback a “hiccup.”

“You just have to change the swab and go through testing again,” he said.

Lin said the swabs couldn’t reach far enough into a person’s nose to properly test for the virus. 

“So what happened was that their swab is for your mouth. Therefore, it cannot fit all the way up into your nose, and you have to actually go pretty high up in the nose,” the doctor said. “Their swab systems are not able to pick up everything.”

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Bad traffic, changed plans: Toronto braces for uncertainty of its Taylor Swift Era

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TORONTO – Will Taylor Swift bring chaos or do we all need to calm down?

It’s a question many Torontonians are asking this week as the city braces for the arrival of Swifties, the massive fan base of one of the world’s biggest pop stars.

Hundreds of thousands are expected to descend on the downtown core for the singer’s six concerts which kick off Thursday at the Rogers Centre and run until Nov. 23.

And while their arrival will be a boon to tourism dollars — the city estimates more than $282 million in economic impact — some worry it could worsen Toronto’s gridlock by clogging streets that already come to a standstill during rush hour.

Swift’s shows are set to collide with sports events at the nearby Scotiabank Arena, including a Raptors game on Friday and a Leafs game on Saturday.

Some residents and local businesses have already adjusted their plans to avoid the area and its planned road closures.

Aahil Dayani says he and some friends intended to throw a birthday bash for one of their pals until they realized it would overlap with the concerts.

“Something as simple as getting together and having dinner is now thrown out the window,” he said.

Dayani says the group rescheduled the gathering for after Swift leaves town. In the meantime, he plans to hunker down at his Toronto residence.

“Her coming into town has kind of changed up my social life,” he added.

“We’re pretty much just not doing anything.”

Max Sinclair, chief executive and founder of A.I. technology firm Ecomtent, suggested his employees avoid the company’s downtown offices on concert days, saying he doesn’t see the point in forcing people to endure potential traffic jams.

“It’s going to be less productive for us, and it’s going to be just a pain for everyone, so it’s easier to avoid it,” Sinclair said.

“We’re a hybrid company, so we can be flexible. It just makes sense.”

Swift’s concerts are the latest pop culture moment to draw attention to Toronto’s notoriously disastrous daily commute.

In June, One Direction singer Niall Horan uploaded a social media video of himself walking through traffic to reach the venue for his concert.

“Traffic’s too bad in Toronto, so we’re walking to the venue,” he wrote in the post.

Toronto Transit Commission spokesperson Stuart Green says the public agency has been working for more than a year on plans to ease the pressure of so many Swifties in one confined area.

“We are preparing for something that would be akin to maybe the Beatles coming in the ‘60s,” he said.

Dozens of buses and streetcars have been added to transit routes around the stadium, and the TTC has consulted the city on potential emergency scenarios.

Green will be part of a command centre operated by the City of Toronto and staffed by Toronto police leaders, emergency services and others who have handled massive gatherings including the Raptors’ NBA championship parade in 2019.

“There may be some who will say we’re over-preparing, and that’s fair,” Green said.

“But we know based on what’s happened in other places, better to be over-prepared than under-prepared.”

Metrolinx, the agency for Ontario’s GO Transit system, has also added extra trips and extended hours in some regions to accommodate fans looking to travel home.

A day before Swift’s first performance, the city began clearing out tents belonging to homeless people near the venue. The city said two people were offered space in a shelter.

“As the area around Rogers Centre is expected to receive a high volume of foot traffic in the coming days, this area has been prioritized for outreach work to ensure the safety of individuals in encampments, other residents, businesses and visitors — as is standard for large-scale events,” city spokesperson Russell Baker said in a statement.

Homeless advocate Diana Chan McNally questioned whether money and optics were behind the measure.

“People (in the area) are already in close proximity to concerts, sports games, and other events that generate massive amounts of traffic — that’s nothing new,” she said in a statement.

“If people were offered and willingly accepted a shelter space, free of coercion, I support that fully — that’s how it should happen.”

This report by The Canadian Press was first published Nov. 13, 2024.



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‘It’s literally incredible’: Swifties line up for merch ahead of Toronto concerts

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TORONTO – Hundreds of Taylor Swift fans lined up outside the gates of Toronto’s Rogers Centre Wednesday, with hopes of snagging some of the pop star’s merchandise on the eve of the first of her six sold-out shows in the city.

Swift is slated to perform at the venue from Thursday to Saturday, and the following week from Nov. 21 to Nov. 23, with concert merchandise available for sale on some non-show days.

Swifties were all smiles as they left the merch shop, their arms full of sweaters and posters bearing pictures of the star and her Eras Tour logo.

Among them was Zoe Haronitis, 22, who said she waited in line for about two hours to get $300 worth of merchandise, including some apparel for her friends.

Haronitis endured the autumn cold and the hefty price tag even though she hasn’t secured a concert ticket. She said she’s hunting down a resale ticket and plans to spend up to $600.

“I haven’t really budgeted anything,” Haronitis said. “I don’t care how much money I spent. That was kind of my mindset.”

The megastar’s merchandise costs up to $115 for a sweater, and $30 for tote bags and other accessories.

Rachel Renwick, 28, also waited a couple of hours in line for merchandise, but only spent about $70 after learning that a coveted blue sweater and a crewneck had been snatched up by other eager fans before she got to the shop. She had been prepared to spend much more, she said.

“The two prized items sold out. I think a lot more damage would have been done,” Renwick said, adding she’s still determined to buy a sweater at a later date.

Renwick estimated she’s spent about $500 in total on “all-things Eras Tour,” including her concert outfit and merchandise.

The long queue for Swift merch is just a snapshot of what the city will see in the coming days. It’s estimated that up to 500,000 visitors from outside Toronto will be in town during the concert period.

Tens of thousands more are also expected to attend Taylgate’24, an unofficial Swiftie fan event scheduled to be held at the nearby Metro Toronto Convention Centre.

Meanwhile, Destination Toronto has said it anticipates the economic impact of the Eras Tour could grow to $282 million as the money continues to circulate.

But for fans like Haronitis, the experience in Toronto comes down to the Swiftie community. Knowing that Swift is going to be in the city for six shows and seeing hundreds gather just for merchandise is “awesome,” she said.

Even though Haronitis hasn’t officially bought her ticket yet, she said she’s excited to see the megastar.

“It’s literally incredible.”

This report by The Canadian Press was first published Nov. 13, 2024.

The Canadian Press. All rights reserved.



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Via Rail seeks judicial review on CN’s speed restrictions

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OTTAWA – Via Rail is asking for a judicial review on the reasons why Canadian National Railway Co. has imposed speed restrictions on its new passenger trains.

The Crown corporation says it is seeking the review from the Federal Court after many attempts at dialogue with the company did not yield valid reasoning for the change.

It says the restrictions imposed last month are causing daily delays on Via Rail’s Québec City-Windsor corridor, affecting thousands of passengers and damaging Via Rail’s reputation with travellers.

CN says in a statement that it imposed the restrictions at rail crossings given the industry’s experience and known risks associated with similar trains.

The company says Via has asked the courts to weigh in even though Via has agreed to buy the equipment needed to permanently fix the issues.

Via said in October that no incidents at level crossings have been reported in the two years since it put 16 Siemens Venture trains into operation.

This report by The Canadian Press was first published Nov. 13, 2024.

Companies in this story: (TSX:CN)

The Canadian Press. All rights reserved.



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