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Feds announce plan to buy 7.9 million rapid COVID tests

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Public Services and Procurement Minister Anita Anand today announced a plan to buy roughly 7.9 million rapid point-of-care COVID-19 tests from U.S.-based Abbott Laboratories.

The purchase is meant to offer other testing options to Canadians at a time when the country’s testing apparatus is being severely strained, with coronavirus caseloads spiking in some regions.

To date, the vast majority of tests have been done at public health clinics, with samples then sent to laboratories for analysis — a process that can take days.

A point-of-care test could be administered by trained professionals in other settings. The molecular test Canada is looking to buy — the ID NOW — can produce results from a nasal swab in as little as 13 minutes.

While Canada has announced this purchase from a well-regarded U.S. firm, the test itself has not yet been approved by Health Canada for distribution.

Proactive purchasing

“As with many of our agreements for equipment, tests and vaccines, we have pursued an advanced purchase agreement to secure Canada’s access to these tests conditional on Health Canada’s regulatory approval,” Anand said.

“These rapid tests will aid in meeting the urgent demands from provinces and territories to test Canadians and reduce wait time for results, which is key to reducing the spread of the virus.”

The U.S. Food and Drug Administration (FDA) first issued an emergency use authorization (EUA) to Abbott for the ID NOW device in March.

Since then, some researchers have said the device has led to false positives in a small number of cases. The FDA re-issued a revised EUA on Sept. 18, saying that the test should be administered within the first seven days of the onset of symptoms.

Anand said that, beyond the Abbott deal, Canada will proactively purchase other rapid tests in bulk to supply the country.

With tens of thousands of tests being done each day, the demand is high.

The announcement comes as Health Canada bureaucrats in charge of regulating new testing devices are defending the government’s response to this point.

 

A lab technician dips a sample into the Abbott Laboratories ID Now testing machine at the Detroit Health Center in Detroit. Illinois-based Abbott Laboratories says its test delivers results within minutes. (Carlos Osorio/AP Photo)

 

Health experts — including Dr. David Naylor, the co-chair of the federal government’s COVID-19 task force — have for weeks been urging regulators to approve rapid testing to take the pressure off testing centres.

While other major Western countries such as the U.S. have authorized a number of point-of-care tests, Health Canada regulators have been slow to give the necessary approvals to deploy these devices.

Regulators approved Cepheid’s Xpert Xpress SARS-CoV-2 device in late March, a test that can be used in both lab and point of care settings.

The next approval for a point-of-care device — one that could be used in a doctor’s office or a walk-in clinic — only came last week.

On Sept. 23, Health Canada approved for use in Canada the Hyris bCube — a portable device that its Guelph, Ont.-based distributor says can be used “wherever people are — anytime, anywhere.”

The regulator hasn’t yet approved any antigen tests — a different form of testing that can be easily deployed to high-risk workplaces and schools to help identify positive COVID-19 cases.

In fact, Health Canada only posted guidance for antigen device manufacturers to its website today, seven months into the pandemic.

The antigen tests — which, depending on the device, use matter collected from a nasal or throat swab — don’t require the use of a lab to generate results.

While much faster, these tests are considered by some to be less accurate than the “gold standard” — the polymerase chain reaction (PCR) testing process currently in use across Canada.

 

U.S. President Donald Trump opens a box containing the ID NOW testing device during a coronavirus briefing at the White House in March. (Alex Brandon/AP Photo)

 

Antigen testing devices like Quidel Corporation’s Sofia 2 SARS, which received emergency authorization from the U.S. FDA in May, can produce results in less than 20 minutes. As of Tuesday, Quidel’s device was listed as “under review” by Health Canada.

Antigen tests have been used in thousands of U.S. long-term care homes for months.

Speaking to reporters on teleconference about Health Canada’s progress, Dr. Supriya Sharma, senior medical adviser to the department’s deputy minister, said she doesn’t think the authorization process has been slow to this point.

She said Canada’s regulatory regime is different from what’s in place in the U.S. and the department has been focused on approving lab-based PCR testing devices.

“I don’t think we’re slow. We’ve got staff working flat out,” she said. “There’s no file sitting on anyone’s desk not being looked at.”

Sharma said it’s difficult to state exactly when the Abbott test or an antigen test will be approved for use in Canada.

“Antigen testing is our number one priority and we are doing everything that we can to review these tests to ensure they are available to Canadians,” she said.

“We have increased the efficiency and we’re streamlining those review processes. We’re committed to getting a company a decision within 40 days,” she said, adding that the pre-pandemic process often would take months to complete.

She said regulators will not be rushed, citing the risk of approving a faulty test that tells people they’re clear of COVID-19 when they’re actually infected.

“A test that doesn’t meet this criteria could have devastating consequences for Canadians,” Sharma said.

When asked if the department was reluctant to approve new devices because of past missteps, Sharma conceded Health Canada’s early decision to authorize a device from Ottawa-based Spartan Bioscience — a test that later proved faulty — resulted in some “lessons learned” for regulators. In May, the National Microbiology Lab found problems with the test that made it unreliable.

While Canadian regulators have not yet given the green light, the World Health Organization (WHO) announced on Monday a plan to send 120 million COVID-19 antigen tests to low- and middle-income countries over the next six months to dramatically expand access to testing in places where PCR isn’t viable due to limited laboratory capacity.

The WHO touted these tests as “highly portable, reliable and easy to administer, making testing possible in near-person, decentralized healthcare settings.”

“High-quality rapid tests show us where the virus is hiding, which is key to quickly tracing and isolating contacts and breaking the chains of transmission,” Dr. Tedros Adhanom Ghebreyesus, the director general of the WHO, said in announcing the plan.

“The tests are a critical tool for governments as they look to reopen economies and ultimately save both lives and livelihoods.”

Asked about the WHO plan after a meeting with UN officials, Prime Minister Justin Trudeau told reporters Canada would rely on its own scientists to determine which devices should be used here at home.

 

 

Prime Minister Justin Trudeau appeared in a United Nations video conference on the COVID-19 crisis 0:47

“As much as we’d love to see those tests as quickly as possible, we’re not going to tell our scientists how to do their job and do that work. We are, however, ensuring that as soon as those approvals happen, we are ready to deliver these tests across the country,” he said.

Raywat Deonandan, an associate professor at the University of Ottawa and an expert in epidemiology, said that while antigen tests can be less sensitive than PCR tests, they can be useful for “reassurance” purposes.

“If someone needs a negative test to go back to work, we’ll use this,” Deonandan said in an interview.

“We need more creative tools on the table and this is one creative tool — again, with the caveat that it matters entirely how you use it, where you use it and by whom,” he said, adding that he believes antigen tests shouldn’t be a primary diagnostic tool.

While antigen tests can be less accurate, they’re also cheap to produce and easy to administer. That means they can be used multiple times to ensure a more accurate reading — not unlike a home pregnancy test.

“The advantage of these types of tests is that you can do them frequently,” said Ashleigh Tuite, an assistant professor at the University of Toronto and an infectious disease researcher.

“You could do it the day that you were going to visit the person who you cared about and it would basically tell you at that point in time, are you infectious? That’s incredibly powerful information.

“It just makes common sense — use every tool you have.”

Source:cbc.ca

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My Boy Prince to race against older horses in $1-million Woodbine Mile

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September 13, 2024

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TORONTO – He’s firmly among Canada’s top three-year-olds but My Boy Prince faces a stiff test Saturday at Woodbine Racetrack.

The ’24 King’s Plate runner-up will be part of a global field in the $1-million Woodbine Mile turf event. Not only will it be My Boy Prince’s first race against older competition but among the seven other starters will be such horses as Naval Power (Great Britain), Big Rock (France) and Filo Di Arianna (Brazil).

My Boy Prince will race for the first time since finishing second to filly Caitlinhergrtness in the Plate on Aug. 23.

“It’s his first try against older horses and it’s hard to say where he fits in,” said trainer Mark Casse. “This time of year running a three-year-old against older horses, it’s like running a teenager against college athletes.

“We’re doing it because we believe a mile on the turf is his preferred surface … we wanted to give him a shot at this. (American owner Gary Barber) is someone who likes to think outside the box and take calculated risks so we’re going to see where he fits in.”

Casse, 16 times Canada’s top trainer, is a Hall of Famer both here and in the U.S. He’s also a two-time Woodbine Mile winner with filly Tepin (2016) and World Approval (2017).

Sahin Civaci will again ride My Boy Prince, Canada’s top two-year-old male who has six wins and 10 money finishes (6-3-1) in 11 career starts. The horse will be one of three Casse trainees in the race with Filo Di Arianna (ridden by Sovereign Award winner Kazushi Kimura) and Win for the Money (veteran Woodbine jockey Patrick Husbands aboard).

Naval Power, a four-year-old, has finished in the money in eight of nine starts (six wins, twice second) and will race in Canada for the first time. He comes to Woodbine with second-place finishes in two Grade 1 turf races.

Big Rock, another four-year-old, makes his North American debut Saturday. The horse has five wins and five second-place finishes in 14 starts but has struggled in ’24, finishing sixth, 10th and fifth in three races.

Filo Di Arianna is a four-time graded stakes winner with nine victories, three seconds and a third from 17 starts. It was Canada’s ’22 top male sprinter and champion male turf horse.

Other starters include Playmea Tune, Niagara Skyline and Secret Reserve.

Playmea Tune, a four-year-old, is trained by Josie Carrol. The gelding has made three starts, winning twice and finishing second in the Grade 3 Bold Venture on Aug. 23.

Woodbine-based Niagara Skyline is a six-year-old with 13 money finishes (six wins, five seconds, twice third) in 24-lifetime starts. The John Charlambous trainee has reached the podium (1-1-1) in all three races this year.

Secret Reserve, also a six-year-old, has finished in the money in 15-of-26 starts (six wins, one second, eight thirds). The horse, at 44-1, was third in the Grade 2 King Edward Stakes over a mile on the E.P. Taylor turf course.

The Mile highlights a stellar card featuring six graded stakes races. Also on tap are the $750,000 E.P. Taylor Stakes (fillies and mares), $500,000 bet365 Summer Stakes (two-year-olds) and $500,000 Johnnie Walker Natalma Stakes (two-year-old fillies), all Grade 1 turf events.

The Mile, Natalma and Summer winners earn automatic entries into the Breeders’ Cup at Del Mar in November.

Casse has won all four races, earning his first E.P. Taylor title last year with filly Fev Rover, Canada’s horse of the year and champion female turf horse. Fev Rover will defend her title Saturday against a field that includes Moira, the ’22 King’s Plate winner and Canada’s horse of the year trained by Woodbine’s Kevin Attard.

“It (E.P. Taylor) was definitely on my bucket list because it had eluded us,” Casse said. “But I honestly hadn’t realized I’d won all four of them, hadn’t really thought about it.”

Casse will have horses in all four turf races Saturday. Arguably the most intriguing matchup will be between Moira and Fev Rover, who ran 1-2, respectively, in a photo finish Aug. 11 in the Grade 2 Beverly D. Stakes, a 1 3/16-mile turf race, at Virginia’s Colonial Downs.

“What’s funny is the two of them went all the way to Virginia and she beat us by a nose,” Casse said. “We could’ve done that at Woodbine.

“There’s two of the best fillies in the world both from Toronto and they’re going to be competing Saturday.”

Some question having so many solid races on a single card but Casse likes the strategy.

“I think it’s a good thing,” he said. “On Saturday, the main focus on horse racing in the world will be on Woodbine and that’s because it’s such a great card.

“It’s an international day, there’s horses coming from everywhere and we’re going to do our best to represent Canada.”

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



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Former world No. 1 Sharapova wins fan vote for International Tennis Hall of Fame

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September 13, 2024

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NEWPORT, R.I. (AP) — Maria Sharapova, a five-time Grand Slam singles champion, led the International Tennis Hall of Fame’s fan vote her first year on the ballot — an important part to possible selection to the hall’s next class.

The organization released the voting results Friday. American doubles team Bob and Mike Bryan finished second with Canada’s Daniel Nestor third.

The Hall of Fame said tens of thousands of fans from 120 countries cast ballots. Fan voting is one of two steps in the hall’s selection process. The second is an official group of journalists, historians, and Hall of Famers from the sport who vote on the ballot for the hall’s class of 2025.

“I am incredibly grateful to the fans all around the world who supported me during the International Tennis Hall of Fame’s fan votes,” Sharapova said in a statement. “It is a tremendous honor to be considered for the Hall of Fame, and having the fans’ support makes it all the more special.”

Sharapova became the first Russian woman to reach No. 1 in the world. She won Wimbledon in 2004, the U.S. Open in 2006 and the Australian Open in 2008. She also won the French Open twice, in 2012 and 2014.

Sharapova was also part of Russia’s championship Fed Cup team in 2008 and won a silver medal at the London Olympics in 2012.

To make the hall, candidates must receive 75% or higher on combined results of the official voting group and additional percentage from the fan vote. Sharapova will have an additional three percentage points from winning the fan vote.

The Bryans, who won 16 Grand Slam doubles titles, will have two additional percentage points and Nestor, who won eight Grand Slam doubles titles, will get one extra percentage point.

The hall’s next class will be announced late next month.

___

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Roots sees room for expansion in activewear, reports $5.2M Q2 loss and sales drop

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September 13, 2024

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TORONTO – Roots Corp. may have built its brand on all things comfy and cosy, but its CEO says activewear is now “really becoming a core part” of the brand.

The category, which at Roots spans leggings, tracksuits, sports bras and bike shorts, has seen such sustained double-digit growth that Meghan Roach plans to make it a key part of the business’ future.

“It’s an area … you will see us continue to expand upon,” she told analysts on a Friday call.

The Toronto-based retailer’s push into activewear has taken shape over many years and included several turns as the official designer and supplier of Team Canada’s Olympic uniform.

But consumers have had plenty of choice when it comes to workout gear and other apparel suited to their sporting needs. On top of the slew of athletic brands like Nike and Adidas, shoppers have also gravitated toward Lululemon Athletica Inc., Alo and Vuori, ramping up competition in the activewear category.

Roach feels Roots’ toehold in the category stems from the fit, feel and following its merchandise has cultivated.

“Our product really resonates with (shoppers) because you can wear it through multiple different use cases and occasions,” she said.

“We’ve been seeing customers come back again and again for some of these core products in our activewear collection.”

Her remarks came the same day as Roots revealed it lost $5.2 million in its latest quarter compared with a loss of $5.3 million in the same quarter last year.

The company said the second-quarter loss amounted to 13 cents per diluted share for the quarter ended Aug. 3, the same as a year earlier.

In presenting the results, Roach reminded analysts that the first half of the year is usually “seasonally small,” representing just 30 per cent of the company’s annual sales.

Sales for the second quarter totalled $47.7 million, down from $49.4 million in the same quarter last year.

The move lower came as direct-to-consumer sales amounted to $36.4 million, down from $37.1 million a year earlier, as comparable sales edged down 0.2 per cent.

The numbers reflect the fact that Roots continued to grapple with inventory challenges in the company’s Cooper fleece line that first cropped up in its previous quarter.

Roots recently began to use artificial intelligence to assist with daily inventory replenishments and said more tools helping with allocation will go live in the next quarter.

Beyond that time period, the company intends to keep exploring AI and renovate more of its stores.

It will also re-evaluate its design ranks.

Roots announced Friday that chief product officer Karuna Scheinfeld has stepped down.

Rather than fill the role, the company plans to hire senior level design talent with international experience in the outdoor and activewear sectors who will take on tasks previously done by the chief product officer.

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

Companies in this story: (TSX:ROOT)

The Canadian Press. All rights reserved.



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