Biovica International
13.9.2021 08:31:52 CEST | ACCESS Newswire | Press release
UPPSALA, SE / ACCESSWIRE / September 13, 2021 / Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II)
Biovica, active in cancer diagnostics, today announced that the company's expected timeline for its updated 510(k)-application to the US Food and Drug Administration (FDA) has been prolonged due to delay in response from FDA.
As Biovica is still waiting for required feedback from the FDA the company has not been able to submit its updated application yet. This means that the company most likely will not receive an answer from the FDA before the end of September, as previously communicated.
After submitting the response to the FDA, the expected outcome is either approval (clearance) or a request to submit more information.
"It is of course unfortunate that the FDA process is delayed. It is caused by the pandemic situation and unfortunately out of our control. We are ready to submit updates to the application but need to have patience and understanding about how the pandemic situation has affected processing times at the FDA. Thankfully, this is a short-term obstacle that will be overcome in due time," said Anders Rylander.
Contact
Anders Rylander, CEO
Phone: +46-18-444 48 35
E-mail: anders.rylander@biovica.com
Biovica - Treatment decisions with greater confidence
Biovica develops and commercializes blood-based biomarker assays to evaluate efficacy of cancer treatments. Biovica's assay DiviTum® measure cell proliferation by detecting a biomarker in the blood stream. The assay has successfully demonstrated its capabilities to early evaluate therapy effectiveness in several clinical trials. The first application for DiviTum is monitoring of treatment for patients with metastatic breast cancer. Biovica's vision is that all cancer patients will get an optimal treatment from day one. Biovica collaborates with world-leading cancer institutes and pharmaceutical companies. DiviTum is CE-marked and registered with the Swedish Medical Products Agency. Biovica's shares are traded on the Nasdaq First North Growth Market (BIOVIC B). FNCA Sweden AB is the company's Certified Adviser, info@fnca.se , +46 8 528 00 399. For more information please visit: www.biovica.com .
This information is information that Biovica International is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2021-09-13 08:07 CEST.
Attachments
Biovica provides update on FDA application process
SOURCE: Biovica International
View source version on accesswire.com:
https://www.accesswire.com/663692/Biovica-Provides-Update-on-FDA-Application-Process
To view this piece of content from www.accesswire.com, please give your consent at the top of this page.
About ACCESS Newswire
Subscribe to releases from ACCESS Newswire
Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from ACCESS Newswire
LiberNovo Omni SE, Omni Pro and Maxis Enter Final Week of Early Bird Launch Pricing24.7.2026 09:00:00 CEST | Press release
HONG KONG, HK / ACCESS Newswire / July 24, 2026 / Seven days is what remains of LiberNovo's 2026 launch pricing. Across the EU and UK, Omni SE, Omni Pro, and the Maxis series hold their early bird prices until July 31, and the window closes there. The whole lineup is built around dynamic ergonomics: the support system links the neck support, backrest, armrests, and seat, so everything moves together as you shift, lean, and recline. The chair follows the movement; you get on with the work. A quick way to choose Omni SE: the simplest build in the lineup. No motor and no battery; you set the lumbar depth by hand and the automatic support does the rest. Solid dynamic ergonomics at the friendlier price. Better Comfort, Simplified. Omni Pro: the premium chair in the lineup. Motorized lumbar adjustment and the OmniStretch guided back stretch at the press of a button, plus Active Airflow ventilation built into the seat for long days and warm rooms, an aluminum base, and Danish Gabriel fabric.
2026 Fields Medals Awarded to Four of World's Top Mathematicians23.7.2026 16:45:00 CEST | Press release
The award, nicknamed the Nobel Prize of mathematics, recognizes outstanding achievement - and the promise of future achievement - by mathematicians under 40. PHILADELPHIA, PA / ACCESS Newswire / July 23, 2026 / During today's opening ceremony at the International Congress of Mathematicians (ICM) in Philadelphia, the International Mathematical Union (IMU) announced the recipients of the 2026 Fields Medals. This year's prizes went to four of the world's top mathematicians: Chinese mathematician Yu Deng of the University of Chicago; American mathematician John Pardon of Stony Brook University in New York; Canadian mathematician Jacob Tsimerman of the University of Toronto; and Chinese mathematician Hong Wang of New York University and France's Institut des Hautes Études Scientifiques (IHES). The Fields Medal is often described as the Nobel Prize of mathematics due to its prestige. Awarded every four years to two to four mathematicians under the age of 40, the medal recognizes outstanding
Karbon-X Secures Technical Advisory Engagement for Nature-Based Carbon Project in Libya22.7.2026 15:00:00 CEST | Press release
Initial engagement expands the Company's international project development portfolio through technical advisory services supporting the design and optimization of a proposed nature-based carbon project. CALGARY, AB / ACCESS Newswire / July 22, 2026 / Karbon-X Corp. (OTCQB:KARX) ("Karbon-X" or the "Company"), a vertically integrated climate solutions company operating across global carbon markets and climate infrastructure, today announced that it has been engaged by Stream Pro Ltd, a subsidiary of Oilinvest to provide technical advisory services supporting the design and value optimization of a proposed nature-based carbon project in Libya. The engagement represents another step in Karbon-X's international project development strategy and further demonstrates the Company's expertise in the design and development of high-integrity carbon projects across emerging markets. Under the initial scope of work, Karbon-X will provide end-to-end technical support for the project's carbon design,
U.S. Polo Assn. Sponsors the 2026 St. Regis British Open Polo Championship for the Cowdray Gold Cup as Official Apparel Partner22.7.2026 13:00:00 CEST | Press release
Gaston Polo Team Claims Gold Cup Title Over Dubai Polo Team at Cowdray Park Polo Club WEST PALM BEACH, FL AND WINDSOR, UK / ACCESS Newswire / July 22, 2026 / U.S. Polo Assn.® in partnership with Brand Machine Group (BMG), its partner in the United Kingdom, proudly continued its long-standing support of the British high-goal season as the Official Apparel Partner of the 2026 St. Regis British Open Polo Championship for the Cowdray Gold Cup, held June 23 through July 19 at Cowdray Park Polo Club, known widely as "The Home of British Polo." 1) 2026 St. Regis British Open Polo Championship for the Cowdray Gold Cup Winners, Gaston Polo Team, accepting trophy on stage at Cowdray Park Polo Club 2) Gaston Polo Team attacking the ball against Dubai Polo Team in the 2026 St. Regis British Open Polo Championship for the Cowdray Gold Cup Final 3) The British Ladies Open Championship Finalists, Yaguara and Salty Polo, on stage at Cowdray Park Polo Club 4) U.S. Polo Assn.'s Experiential Merchandise
House of Hope in Bamako Continues to Provide Vital Support for Vulnerable Women in Mali in 202622.7.2026 11:00:00 CEST | Press release
BUDAPEST, HUNGARY / ACCESS Newswire / July 22, 2026 / The Gedeon Richter House of Hope centre in Bamako, Mali, continued to provide comprehensive support for vulnerable women and girls during the first half of 2026, delivering healthcare, protection, counselling, education and vocational training through its integrated programme. In the first six months of is year, nearly 50 women have been provided assistance in the center. Established through the cooperation of Gedeon Richter, the Hungary-based Close to Africa Foundation, and local partner Sini Sanuman Foundation, the House of Hope opened at the beginning of 2025 to offer shelter, gynaecological care, psychosocial and legal support, as well as educational and skills-development opportunities to women affected by violence and harmful traditional practices. Since opening its doors, the centre has supported well over a hundred women, while community outreach and awareness-raising activities have reached many more across Bamako and surro
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom