Biovica continouse to increase 12m rolling IVD test sales in Q3 of SEK 0.
Biovica records IVD test sales in Q3 of SEK 0.74m (460% above Q3 last year) and total sales of SEK 2.
Eurobio will cover France, Benelux, Germany, Switzerland, and the UK.
Biovica records another quarter of modest quarterly IVD test sales growth of 50-55% (compared with the previous quarter), with improving pro...
Biovica records IVD test sales in Q2 of SEK 0.97m , which is 54% above the previous quarter (Q1) and 129% above the earlier quarter (Q4), de...
The US company is both a health insurance and a health care service provider covering more than 10m lives, and this suggests that this is on...
SABCS (San Antonio Breast Cancer Symposium) is a major annual US cancer conference, and this year, Biovica’s DiviTum test will be featured i...
The 15th MSA agreement suggests that Biovica has secured well over 20 MSA-based projects.
Biovica records consecutive quarterly IVD test sales growth of 40-50%, with good prospects ahead.
Biovica records IVD test sales in Q1 of SEK 0.62m, which is 50% above the previous quarter (Q4) and 100% above the earlier quarter (Q3), des...
Biovica records IVD test sales in Q4, which are higher than Q1-Q3, and research test sales have increased by 300% in 2023/23.
Biovica is about to implement an annual SEK 30m cost-saving program.
Today’s announcement opens the possibility of international patent protection for DiviTum outside the breast cancer space, including the mar...
Biovica continues to advance DiviTum among clinical users, but the absolute sales levels are still modest.
Biovica’s sales from clinical use of DiviTum tests are up 350% in Q3 compared with the first half, and the Pharma-related sales order book h...
Biovica, active in blood-based cancer monitoring, has signed a master service agreement, enabling Biovica to provide its TKa testing assay a...
The Master Agreement is distinctly positive and adds to the potential sales contribution, which can be very substantial with an exponential ...
The Palex group of 800 professionals with a long history as a leading provider of advanced solutions for healthcare professionals in hospita...
Biovica’s right issue secures SEK 100m, and the number of shares will increase from 45.
The recent Medicare price of USD 322 is the latest progress during a quarter of improved commercial presence including Direct Bill, Hospital...
The recent CMS Medicare price of USD 322 is the last progress during a quarter of improved presence including Direct Bill, Hospital contract...
The early CMS price decision is good news and the price is in our view within the expected DiviTum price range for the Medicare channel.
Biovica has established a partnership agreement with Axlab (A/S) to commercialize the DiviTum in the Nordics.
Biovica commits to a new partly guaranteed (84% covered by commitments, guarantees and undertakings) Right Ussue of units with preferential ...
Bivoca has signed a direct bill contract providing access to DiviTum TKa to appropriate patients treated at a leading cancer centre in Flori...
The gap-fill process will allow Biovica to secure a Medicare (CMS) code and a preliminary price as of early 2024.
Biovica has signed its second direct commercial client bill agreement with a larger healthcare provider operating 18 hospital laboratories,...
Biovica has signed the first direct commercial client bill agreement with a larger healthcare provider operating more than 30 hospital labor...
Biovica has signed three commercial agreements during Q1 but has not yet completed any of the direct contract with hospital chains (or Hospi...
Biovica delivers early sales progress with SEK 1.7m in Q1 sales.
AMA has approved a specific PLA code for Biovica's DiviTum test that will come into effect by 1st of October later this year.
Redeye updates our Biovica outlook after reporting the full 2022/23.
Q4 highlights that Biovica has secured two contracts with Contigo Health and MedIncrease, access to a respectable proportion of the US priva...
Biovica has signed a provider contract with Contigo Health ConfigureNet provider network.
Biovica has signed a provider contract with MediNcrease Health Plans, a national provider network and provider advocacy firm.
Redeye updated our Biovica outlook after securing access to growth capital and initiating the US and European launch.
Biovica has secured the initial European launch of DiviTum after signing Toro Medical Group as a commercial partnership agreement for the Ne...
With the recent CLIA lab certification (the US lab in San Diego), Biovica is moving into the next stage.
Biovica’s US lab secures a CLIA certification following a successful site visit in January.
Biovica has secured the SEK 140m new funds in growth capital and the US commercial team is also in place.
Biovica has secured a right issue and the next step is the US launch.
The guaranteed right issue will secure growth capital supporting the US launch and to advance the European commercialisation based on distri...
DiviTum could be used to confirm treatment response Path forward toward a sales launch by year-end Q1’22/23 EBIT of SEK -21m, cash positi...
Biovica is preparing ahead of the US launch, and the next milestone is to secure a certification for its own lab in San Diego servicing the ...
Biovica recently hosted a post-FDA approval commercial update for DiviTum on the 18th of August.
Finally, Biovica has secured US approval (510k) for DiviTum in the core market indication.
The long-awaited FDA decision announced on 30 July Management looks to have the test available by year end Opens up USD 200-350m annual ...
FDA decision expected in Q3, potential sales start in Q4 DiviTum shown complimentary to ctDNA Q4’21/22 EBIT of SEK -19m, cash position of SE...
Biovica can point to significant progress lately. The FDA submission was cleared well before schedule, and DiviTum is securing additional sc...
Biovica’s CLIA certified San Diego lab, together with the summer of 2022 FDA 510 (k) approval is the backbone of Biovica’s strategy to reach...
Demand generation important for CLIA lab strategy Multiple angles to market the product US launch will follow after 510(k) decision Upda...
Biovica has now submitted the updated FDA application.
The essential Q3 (November-January) feedback is that the FDA process progresses without significant internal or external disruptions.
When Biovica announced that the FDA was not yet ready to accept Biovica’s updated application, this triggered a severe negative overreaction...
Biovica's next step before the FDA decision is to formally submit the updated application after addressing all FDA's questions from earlier ...
510(k) clearance feedback could be one month away Appointment of President of the Americas Q1’21/22 EBIT of SEK -12.
Redeye's Q1 conclusion is that the US DiviTum approval is on track and that a decision is likely in September alternatively after addressing...
The local and regional peer company, Arocell, withdrew the FDA application and may reapply a De Novo submission in due course.
