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Antithrombin Blood Test from Siemens Healthineers Now FDA Cleared as a Companion Diagnostic for Qfitlia, a Sanofi Hemophilia Therapy

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Antithrombin Blood Test from Siemens Healthineers Now FDA Cleared as a Companion Diagnostic for Qfitlia, a Sanofi Hemophilia Therapy
News

News

Antithrombin Blood Test from Siemens Healthineers Now FDA Cleared as a Companion Diagnostic for Qfitlia, a Sanofi Hemophilia Therapy

2025-03-29 04:21 Last Updated At:04:41

TARRYTOWN, N.Y.--(BUSINESS WIRE)--Mar 28, 2025--

Siemens Healthineers announced today its Innovance Antithrombin assay has achieved FDA clearance for a new claim allowing it to be used as a companion diagnostic test for people receiving treatment with Qfitlia ™ (fitusiran), a Sanofi hemophilia therapy. 1 Hemophilia is a lifelong genetic bleeding disorder that significantly affects the day-to-day lives of people living with the disease, creating potentially life-threatening risks from otherwise normal situations experienced by those without hemophilia. The body’s inability to clot blood effectively can prolong bleeding after injuries, result in excessive bruising and joint pain, and increase risks during surgery or other medical procedures.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250328113315/en/

Qfitila will support people living with hemophilia A or B, with or without inhibitors, by helping to rebalance one of the body’s critical clotting mechanisms to prevent bleeding. The Innovance Antithrombin blood test from Siemens Healthineers will aid in monitoring patients’ AT activity to support Qfitlia dosing in adult and pediatric patients aged 12 years and older. It is the only assay cleared for this indication.

“Every healthcare industry player has a meaningful role in driving patient care forward. When we collaborate to innovate, we can achieve impactful advancements that can change lives and improve patient outcomes. Diagnostics tests such as the Siemens Healthineers Innovance Antithrombin assay provide greater clinical utility when test results directly aid patients' next step in their treatment,” said Bob Stowers, head of Specialty Lab Solutions, Diagnostics, Siemens Healthineers.

The Innovance Antithrombin assay from Siemens Healthineers is used broadly to detect genetic or acquired AT deficiencies.

1 This expanded claim is intended for use in the United States. Claims relevant to use cases in other markets can be found on the Siemens Healthineers website.

All trademarks are the property of their respective owners.

Siemens Healthineers pioneers breakthroughs in healthcare. For everyone. Everywhere. Sustainably. The company is a global provider of healthcare equipment, solutions and services, with activities in more than 180 countries and direct representation in more than 70. The group comprises Siemens Healthineers AG, listed as SHL in Frankfurt, Germany, and its subsidiaries. As a leading medical technology company, Siemens Healthineers is committed to improving access to healthcare for underserved communities worldwide and is striving to overcome the most threatening diseases. The company is principally active in the areas of imaging, diagnostics, cancer care and minimally invasive therapies, augmented by digital technology and artificial intelligence. In fiscal 2024, which ended on September 30, 2024, Siemens Healthineers had approximately 72,000 employees worldwide and generated revenue of around €22.4 billion. Further information is available at www.siemens-healthineers.com.

Siemens Healthineers announced today its Innovance Antithrombin assay has achieved FDA clearance for a new claim allowing it to be used as a companion diagnostic test for people receiving treatment with Qfitlia (fitusiran), a Sanofi hemophilia therapy.

Siemens Healthineers announced today its Innovance Antithrombin assay has achieved FDA clearance for a new claim allowing it to be used as a companion diagnostic test for people receiving treatment with Qfitlia (fitusiran), a Sanofi hemophilia therapy.

Ariana Grande, Teyana Taylor, Timothée Chalamet and a sea of other stars said goodbye to color at this year's Golden Globes, opting instead for black. And many in the crowd stuck with tried and true old Hollywood glamour Sunday.

But even in basic black, the red carpet had plenty of personal flourishes and playful embellishments.

Risk-takers Taylor, a winner for “One Battle After Another,” and Jenna Ortega went with “whale tails,” aka the tops of thongs, peeking out the backs of their black gowns. Taylor did it with her custom slinky Schiaparelli gown that showed off a deep low-cut back with a glittery low-hanging bow thong. Ortega, keeping it goth, wore a Dilara Findikoglu gown with black shoulder tassels and a black thong.

“I thought that was such a cheeky callback to Y2K fashion,” InStyle Fashion Director Kevin Huynh said. “I was just like, wow, you wouldn’t expect that on a red carpet.”

Grande left behind her “Wicked” character's signature pink color for a black Vivienne Westwood couture dress but brought back her ponytail. Other notable celebrities in black included Ayo Edebiri, Selena Gomez, Miley Cyrus and Mia Goth.

Edebiri chose a black off-the-shoulder Chanel dress embellished with jewels on the shoulders from Matthieu Blazy’s Métiers d’Art 2026 show.

Celebrities held onto their gowns and watched their steps as they posed for photos on high stairs that served as the red carpet. Like the Met Gala, they lined up at the bottom and had to perilously climb their way up.

The 83rd Golden Globes gives a glimpse into how celebrities will showcase their original take on fashion as the awards season progresses. Since 1944, the show has honored the best in film and television.

The carpet, at The Beverly Hilton in Beverly Hills, California, is a chance for nominees to make a statement, though some are beholden to fashion houses who pay them as ambassadors.

Several, including George Clooney, wore Giorgio Armani. The fashion world lost Armani in September, but his eponymous brand lives on.

“It was nice to see so many attendees, including Julia Roberts and Kate Hudson, wearing the brand and pay tribute,” said Véronique Hyland, fashion features director for Elle.

Not all celebrities followed the black dress trend.

Host Nikki Glaser, who held hosting duty for the second time, wore a strapless satin blush-pink corseted satin gown with a full skirt by Zuhair Murad. Emma Stone stunned in a butter yellow Louis Vuitton skirt set.

“Sinners” star Wunmi Mosaku stunned in a flowy yellow Matthew Reisman gown. The mother-to-be revealed her baby bump on the carpet. Mosaku's co-star Hailee Steinfeld showed off her pregnant figure on the carpet in a peach colored gown.

Stars shone in metallics. “Sentimental Value” actor Renate Reinsve twirled on the carpet in a shimmery silver tasseled dress by Nicolas Ghesquiere for Louis Vuitton. Her co-star Elle Fanning's Gucci dress was embroidered with Norwegian flowers in honor of their Norwegian drama film.

Rising star Chase Infiniti reflected back the carpet and all its stars in her mirrored corseted gown by Nicolas Ghesquiere for Louis Vuitton.

“She’s now Louis Vuitton ambassador, which I think kind of shows her potential as a star,” Vanity Fair style writer José Criales-Unzueta said. “So much of what happens behind the scenes helps define what we’re looking at, whether it’s a deal, whether it sponsorship, whether it is brand ambassadorship.”

Claire Danes eschewed the academic, laid-back tailored looks of her “Beast in Me” character for an effortlessly elegant, couture gown designed by her close friend Zac Posen for GapStudio. Posen and Danes’ friendship and creative collaboration began in high school.

Posen began working on Danes' Golden Globe gown in November. As both creative director for Gap and GapStudio designer, Posen told The Associated Press that elevating the American essential into eveningwear is part of his creative process for the brand.

For Danes' look, Posen transformed the concept of the classic Gap pocket T-shirt into an off-white silk jersey couture gown with subtle bugle beaded detailing and embroidery. The shimmering dress featured a low scoop back and front pocket detail.

“Claire has a great elegance to her and is deeply inherently sophisticated, but yet cool,” Posen said. “Those elements fit perfectly with one of our icons that has built and defined our brands, the pocket tee.

Celebrities are keeping the sheer dressing trend alive with no signs of it slowing down. Lisa of Blackpink wore a black sheer Jacquemus dress, and Jennifer Lopez posed in a see-through dress by Jean-Louis Scherrer.

Jennifer Lawrence walked the carpet in a floral sheer dress by Sarah Burton at Givenchy and accessorized her look with a glamorous floral silk stole.

“Just to go out in a naked dress that leaves very little to the imagination is one thing but what Jennifer Lawrence did was such a romantic approach to it,” Huynh said. “I think that really says a lot to Sarah Burton, the designer of Givenchy. She is a woman designing for women.”

The male nominees didn’t stray too far from traditional looks. Colman Domingo pared down his typical colorful suits for a black suit by Valentino adorned with silver leaf brooches down his lapel. Timothée Chalamet, a winner for “Marty Supreme,” has become one to watch for his fashion choices. Departing from his past colorful looks, Chalamet wore a black velvet vest and jacket from Chrome Hearts with black Timberland boots. Chalamet's partner of three years, Kylie Jenner, did not walk the carpet with the actor, but viewers captured her in a custom silver column look by Ashi Studio. It was hand-embroidered with a fan-shaped crystal bead neckline.

After his viral premiere orange look for “Marty Supreme,” Criales-Unzueta said Chalamet decided on a more traditional movie star style by choosing all black.

“Heated Rivalry” star Hudson Williams brought the cummerbund back but with a laid-back twist. The breakout star paired a white-peak lapel dinner jacket with an unbuttoned silk shirt. Williams, along with his co-star Connor Storrie, were presenters during the ceremony. Storrie wore a black tuxedo jacket by Saint Laurent, with black tie and shades.

“It’s really just sexy takes on classic menswear with just those little bit of edge to things,” Huynh said.

Jenna Rosenstein, beauty director for Harper’s Bazaar, noted Storrie's hair transformation. He plastered his trademark curly locks into a shaggy, retro-inspired mullet. Among the women, beauty highlights included the swoopy bobs of Edebiri and Gomez, she said.

“If there’s one thing you should invest in after this carpet, it’s a really good round brush, a can of hairspray and a statement lipstick,” Rosenstein said.

AP writer Leanne Italie contributed to this report.

For more coverage of the 2026 Golden Globe Awards, visit: https://apnews.com/hub/golden-globe-awards

Timothee Chalamet arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Timothee Chalamet arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Miley Cyrus arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Miley Cyrus arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Ariana Grande arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Ariana Grande arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Ariana Grande arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Ariana Grande arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Connor Storrie arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Connor Storrie arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Colman Domingo arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Colman Domingo arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Ayo Edebiri arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Ayo Edebiri arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Jenna Ortega arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Jenna Ortega arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Jenna Ortega arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Jenna Ortega arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Teyana Taylor arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Richard Shotwell/Invision/AP)

Teyana Taylor arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Richard Shotwell/Invision/AP)

Teyana Taylor arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Teyana Taylor arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Justine Lupe arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Justine Lupe arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Brittany Snow arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Brittany Snow arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Brittany Snow arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Brittany Snow arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Wunmi Mosaku arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Wunmi Mosaku arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Lisa arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Lisa arrives at the 83rd Golden Globes on Sunday, Jan. 11, 2026, at the Beverly Hilton in Beverly Hills, Calif. (Photo by Jordan Strauss/Invision/AP)

Ariana Grande arrives at the 31st Annual Critics Choice Awards on Sunday, Jan. 4, 2026, at The Barker Hanger in Santa Monica, Calif. (Photo by Richard Shotwell/Invision/AP)

Ariana Grande arrives at the 31st Annual Critics Choice Awards on Sunday, Jan. 4, 2026, at The Barker Hanger in Santa Monica, Calif. (Photo by Richard Shotwell/Invision/AP)

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