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
Assembly Chosen to Power Global Paid Media and Amazon Growth for Jabra24.2.2026 15:50:00 CET | Press release
LONDON, GB / ACCESS Newswire / February 24, 2026 / Assembly, the global omnichannel agency built to make brands perform, has been appointed by Jabra, world leading brand in audio, video, and collaboration solutions, as its global paid media agency and lead partner for Amazon services following a competitive pitch process. Assembly's remit spans full-funnel paid media across search, social, display, video, and retail media, alongside Amazon strategy and marketplace operations, to fuel Jabra's next phase of global growth. Pitch Consultants, Tuffon Hall Consultancy, commented: "This was an exceptionally competitive process, and Jabra's new move towards a direct-to-consumer model marks a major shift for the business. Assembly impressed with a powerful proposition, using their proprietary platform STAGE to create a true intelligence engine for Jabra that supports smarter, more connected growth." Why Jabra chose Assembly Assembly was selected for its ability to connect brand and performance,
GA-ASI Develops Long-Range Weapons Capabilities for MQ-9B23.2.2026 13:10:00 CET | Press release
Industry Leading UAS Expands Mission Roles To Include Naval Strike SAN DIEGO, CA / ACCESS Newswire / February 23, 2026 / General Atomics Aeronautical Systems, Inc. (GA-ASI) is developing the addition of long-range standoff weapons to its top-of-the-line MQ-9B SkyGuardian® and SeaGuardian®. Demand continues from naval and air warfighters for platforms that can hold targets at risk from great ranges, especially over the expanses of air and water in the Western Pacific. That's why GA-ASI engineers have begun the work of adapting MQ-9B's payload, stability, range and other features to accommodate the new generation of extended-range precision weapons. "MQ-9B continues to impress in the field and we keep adding to our global customer list," said GA-ASI President David R. Alexander. "We want to continue to build value in the aircraft by expanding into more missions. MQ-9B features extraordinary payload capacity, so it only makes sense to add to our mission sets with the ability to carry long
GA-ASI and USAF Demonstrate Manned-Unmanned Teaming With F-22 and MQ-20 In Joint Autonomy Exercise23.2.2026 13:05:00 CET | Press release
SAN DIEGO, CALIFORNIA / ACCESS Newswire / February 23, 2026 / In collaboration with the U.S. Air Force, General Atomics Aeronautical Systems, Inc. (GA-ASI) conducted its latest demonstration performing an autonomous mission out of Edwards Air Force Base in Southern California using its MQ-20 Avenger® unmanned jet and an F-22 Raptor equipped with the latest government reference autonomy software. The test, which showcased Manned-Unmanned Teaming between the F-22 and MQ-20, leveraged autonomy and the tactical data link to enable coordination between the platforms. The mission included a live engagement between the MQ-20 and the F-22 as the command aircraft flown by an onboard human pilot, highlighting the ability to receive and execute teaming commands. "We appreciate the flawless execution of this mission using the government's advanced autonomous systems," said GA-ASI President David R. Alexander. "This demo featured the integration of mission elements and the ability of autonomy to ut
GA-ASI Announces YFQ-42A Dark Merlin23.2.2026 13:00:00 CET | Press release
Uncrewed Fighter Jet Takes Inspiration From Nimble Predator SAN DIEGO, CA / ACCESS Newswire / February 23, 2026 / General Atomics Aeronautical Systems, Inc. (GA-ASI) is giving its U.S. Air Force Collaborative Combat Aircraft a new name: YFQ-42A Dark Merlin. Dark merlins, deadly falcons known for their black feathers and devouring of other falcons as prey, often collaborate in groups for maximum effect against their targets. The Cornell Lab of Ornithology describes the merlin as a "small, fierce falcon that uses surprise attacks" to bring down its prey in flight. The dark merlin is native to the Pacific Northwest of the United States, often migrating into southern California, where bird spotters routinely report seeing them near the YFQ-42A's manufacturing home in San Diego. The 1962 book "Profiles of the Future" imagined global technological marvels yet to change the world, offering that "any sufficiently advanced technology is indistinguishable from magic." It's no coincidence that th
Datavault AI Announces Anticipated Launch of Josh Gibson Stablecoin and Josh Gibson NIL Strategies for Its Forthcoming NIL Exchange20.2.2026 14:08:00 CET | Press release
PHILADELPHIA, PA / ACCESS Newswire / February 20, 2026 / Datavault AI Inc. (NASDAQ:DVLT) ("Datavault AI" or the "Company"), a leader in data monetization, credentialing, digital engagement and real-world asset (RWA) tokenization technologies announced today the anticipated launch of the Josh Gibson Stablecoin and dedicated Josh Gibson Name, Image, and Likeness (NIL) strategies for its forthcoming sports and entertainment focused NIL digital asset exchange. This initiative builds directly on Major League Baseball's (MLB's) historic integration of Negro Leagues (1920-1948) statistics into the official major league record and celebrates Black History Month by honoring the legacy of baseball icon Josh Gibson. As outlined in the MLB's May 2024 press release, the statistics of the Negro Leagues have officially entered the major league record, recognizing the achievements of thousands of black players previously excluded from MLB. Josh Gibson, widely regarded as one of the greatest catchers a
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