DiviTum® has the potential to contribute key information to the evaluation and treatment of women with hormone receptor-positive metastatic breast cancer. We look forward to seeing the DiviTum® results from this new correlative study of S0226,
We are very pleased that SWOG Cancer Research Network will include DiviTum® in their new study. Results are planned to be the backbone in our FDA 510(k) submission. We are convinced that DiviTum® has the potential to significantly improve evaluation of treatment efficacy for patients with metastatic breast cancer,
It’s encouraging that a key application for DiviTum® is given attention in this scientific article, summarizing the evidence so far. For patients with metastatic breast cancer, the published results support that DiviTum® can be used to evaluate the treatment efficacy of CDK 4/6 inhibitors. We aim to supply DiviTum® as a tool that can contribute to improved outcome for patients
The feedback from FDA and the access to samples from the large US trial in collaboration with the well-established US oncology group offers an excellent opportunity for Biovica to have a solid foundation for our 510(k) submission and clinical validation. This important for future commercial success. A 510(k) clearance for DiviTum will make the product available for US patients and is an important step in fulfilling our vision to enable best treatment outcome for patients.
After completing and publishing 17 clinical trials in total out of which 8 are within breast-cancer, we’re seeing a recurring pattern of the value DiviTum® can bring to cancer patients. Hence, it is important for us to summarize this into a document in order to provide the big picture. The results further strengthen our belief that we can achieve our vision – Best treatment from day one!
Endocrine therapy remains the backbone treatment of choice for patients with metastatic breast cancer expressing hormone receptors; however, as clinicians, we currently do not have tools to early identify those patients who will do good with endocrine therapy alone or may need additional treatment. The results from our work with DiviTum® are exciting and confirm, in a larger number of patients, our previous observation that this assay may indeed help clinicians in this hard task. DiviTum® will certainly become a very useful tool for the development of innovative clinical trials in this field, and ultimately for clinical practice.
These results reinforce what we have seen in previous studies, proving that DiviTum® can provide clinically relevant information highly beneficial for women with advanced breast cancer on hormonal therapy. These results strengthen our belief that DiviTum® can contribute to a better treatment outcome for cancer patients.
DiviTum® will give us an excellent opportunity to generate value for our customers. We look forward to working with Biovica and to expand our product portfolio within the oncology research product line
Besides Biovica’s on-going commercialization initiative for the clinical breast cancer market, we also wish to contribute to the development of new improved oncology drugs. Biovica already have customers in the US research market and on-going collaborations with prominent research institutes. The partnership with IBL-America will create excellent opportunities to grow the customer base for the research market in the US
We are excited to work with IBL-America, a company with long experience of distributing high quality laboratory research products in the US. IBL-America will become an important partner to increase our presence for the important US research market
It is important for Biovica to protect our unique technology. Hence, it is very positive that we now strengthen our patent protection on our most important market.
We are glad to see that there is a demand for DiviTum® on the research market and an interest to include it in clinical trials in order to effectively follow up cancer treatments. We’re pleased that pharma companies see the value of our product and use it in clinical trials in order to provide better treatments for the patients
When we were listed on Nasdaq First North in March 2017, we had an ambitious development plan that we have delivered according to and we are approaching the commercialization of DiviTum®. In the plan, there have also been thoughts of eventually listing the company on the stock exchange’s main list and listing on Nasdaq First North Premier is a first step in that direction. The move to First North Premier is an important quality mark that opens up for more institutional investors to invest in the company
This study provides evidence that DiviTum can be used to evaluate the efficacy of palbociclib in metastatic breast cancer. The results are encouraging in terms of clinical value. Via a blood test we can considerably improve our understanding when to use these new drugs and which patients should be selected for therapy for optimal outcome for each patient
For patients with metastatic breast cancer, we now have clinical evidence that DiviTum® can be used to evaluate the treatment efficacy of a CDK 4/6 inhibitor. It is a milestone presenting these results addressing clinical efficacy of CDK 4/6 inhibitors from our ongoing trial program. We look forward to an exciting year, preparing our DiviTum® FDA application
First of all, I’d like to thank Göran Brorsson for his commitment and important contribution to the development of Biovica during a period of time where the company has had a very positive development. If Göran has been an important part in laying the foundation for our upcoming commercialization, Lars will be equally important as the cairman during the commercialization phase. Lars brings a unique experience and an exceptional international network, I’m looking forward to work with Lars in the process of bringing DiviTum to the market and realizing great potential the shareholders, patients and payers.
Personalized treatments will continue to revolutionize healthcare. Both in regard to patients need for better treatment outcome and due to accelerating treatment costs that demands more cost-effective treatments. The DiviTum standardized blood test addresses both these challenges, Patients with metastatic breast cancer benefits from improved survival and payers will avoid expensive treatments that doesn’t benefit the patient. I’m looking forward to taking part in the development of Biovica and the commercialization of DiviTum. The potential is undeniably huge!
The implementation of ISO 13485:2016 shows that Biovica successfully maintains the quality standard required to put DiviTum® on the market. The certificate is a milestone for our company and our work to get DiviTum® with the highest quality and safety at the market
Biovica strives to produce DiviTum® that will meet regulatory and customer’s expectation. With the implementation of the ISO 13485:2016, Biovica is fully aligned with the global regulatory requirements. The certification is a key step in the process of achieving FDA approval
We are happy to be one of the chosen innovative companies to develop our manufacturing process here at the Testa Center. This opportunity is a project for us where we can reduce risk and accelerate time to market. A stable manufacturing process is a key success factor to be able to scale up our production capacity and at the same time meet regulatory requirements
This collaboration will be very valuable for us in this expansion phase to effectively scale-up our production process to meet expected demand. Access to knowledge and equipment through the Testa Center is a huge advantage and we’re happy that there are such opportunities in Sweden. Being able to scale up production and at the same time meeting regulatory requirement is essential in order for us to fulfill our vision: Best treatment from day one!
This is a great opportunity to interact with Biovica’s target audience and present the possibilities of DiviTum® to key people in the industry. I look forward to present the unique study results of DiviTum® as a liquid biomarker for fast evaluation of drugs that inhibit the cell cycle. It’s great to be invited again to present at the congress on the highly interesting and actual topic of liquid biomarkers in oncology drug development and clinical validation
By establishing an office in the biotech hub Boston, we shorten the distance to our customers and partners. This is an important milestone in the process of commercializing DiviTum and fulfilling our vision: Best treatment for cancer patients from day one!
With local presence, we will be able to increase our business development activities in the US. I look forward to continue the collaboration with our existing partners, as well as establish new commercial opportunities for Biovica.
This study provides more understanding and knowledge of the effect of treatment with palbociclib on a cellular level and evidence that the efficacy of palbociclib is reflected with DiviTum and is directly related to treatment effect
In this pre-clinical trial, we are able to repeat the same pattern we’ve seen in clinical trials. This strengthens the hypothesis that DiviTum is a valuable tool as a pharmacodynamic marker of CDK 4/6 inhibition. Our aim is to contribute to more personalized cancer treatment for the best possible outcome for the patient
I'm both happy and very pleased that Lars Holmqvist joins Biovica at this exciting time. With his long experience and broad expertise in the healthcare sector, Lars will add value to the ongoing commercialization process of DiviTum
During my time as President and CEO of Dako, the company invested in a number of leading companion diagnostic products that resulted in global development agreements with several big pharma companies. I am convinced that personalized treatments will continue to revolutionize healthcare, both with regard to the individual in need of treatment, but also with regard to healthcare costs. I therefore see great potential with DiviTum and are now looking forward to support the management to fully develop it
I am impressed with Biovica's ambitions and what the company has achieved so far. DiviTum will make a big difference for the world's cancer patients and is well positioned for the increasing amount of targeted treatments in the field. I'm really looking forward to contributing to the continued commercialization of DiviTum® and realizing the great potential of the company's products,
I am very pleased that Wing Cheng will reinforce an already strong team. Wing’s experience and expertise in the market access area will add great value to Biovica
The feedback from the FDA is important to us so that we can conduct analytical validation in a manner that ensures that we meet the FDA's requirements and in the long run receive a 510(k)-clearance so the product can benefit patients,
It is a great achievement for Biovica to have passed another milestone in the regulatory approval process for the US market. This process and these milestones are important for meeting our objective, an approved product that can contribute to an individualized treatment for hormone-positive breast cancer and thus the best possible treatment results for the patients.
It is important for Biovica to protect our unique technology. Hence, it is positive news that we get improved patent protection on one of the more important markets. Patent protection is important in order to be able to bring our products to the market to contribute to best possible treatment for cancer patients.
The biomarker area is currently growing rapidly and predictive markers are in high demand by medical authorities, pharma companies and treating physicians
We’ve noticed an increase in demand for our biomarker by pharma companies developing new drugs. The agreement with WntResearch gives us added knowledge in yet another tumor disease area with the objective to increase patients selected for improved and tailored therapy. We want to contribute to best possible outcome for patients by personalizing the treatment
Circulating levels of TK1, as measured by the DiviTum assay, have demonstrated to be strongly associated with outcome of patients treated with endocrine therapy in different independent datasets, and early data suggest that changes of this proliferation marker during treatment could further inform of treatment benefit. DiviTum assay may be a useful tool in exploring early efficacy signals of oncology agents in development.
We look forward to present the results at ASCO showing that DiviTum is able to evaluate treatment efficacy for patients with metastatic breast cancer, treated with endocrine standard treatments. The large number of patients included in the trial also contributes to the strength of the results. We appreciate collaborations with leading pharma companies, like the one with AstraZeneca, and supporting the development of new and improved cancer treatments for better patient outcome.
Endocrine therapy is the treatment of choice for patients with metastatic breast cancer expressing hormone receptors; however, as clinicians, we currently do not have tools to early identify those patients who will do good with endocrine therapy alone or may need additional treatment. The results from our work with DiviTum are exciting and confirm in a larger number of patients our previous observation that this assay may indeed help clinicians in this hard task. DiviTum will certainly become a very useful tool for the development of innovative clinical trials in this field, and ultimately for clinical practice.
These results reinforce what we have seen in previous studies, proving that DiviTum® can provide clinically relevant information highly beneficial for women with advanced breast cancer on hormonal therapy. We are convinced that bringing products like DiviTum® to the market will contribute to bringing the best possible treatment for cancer patients.
I'm looking forward to start working with the Biovica team and making DiviTum commercially available. It's inspiring to work with a product with so much potential, both from a human and commercial perspective!
Pontus Nobréus is an important addition to Biovica. His personality and extensive experience of successfully taking diagnostic products to the market will be important as Biovica enters the phase of commercializing the product.
Local presence is important for getting closer to key customers and partners in the United States.
We are pleased that DiviTum is included by Pfizer in their clinical development of Ibrance®. These positive results are in line with previously presented DiviTum data evaluating biologic effect of demonstrating CDK 4/6 inhibition in connection with treatment of breast cancer. The results take us yet another step closer to our vision of enabling the best possible treatment for cancer patients from day on
I believe this is something that will eventually make a big difference for patients and I hope this will be available soon in the clinic. Besides new drugs, which are great, I think tools like DiviTum are even more important because they allow the physician to make good use of the available drugs
The group of patients that took part of the study corresponds to 80% of women living with breast cancer. The results provide evidence that DiviTum can give early feedback when evaluating treatment outcome for this large and important group of patients. Going forward, Biovica are aiming to repeat these strong results for more patients in order to provide DiviTum as a standard tool for early evaluation of metastatic cancer treatments.
Our study provides the first clinical evidence of using DiviTum for measuring TK1 activity for early evaluation of the effect of palbociclib treatment in breast cancer. The results are very promising and support future studies of DiviTum to evaluate and identify patients for response to CDK 4/6 inhibitors
These results correlating DiviTum to palbociclib efficacy are highly promising since there is no other blood based biomarker available for evaluating CDK 4/6 inhibitor efficacy today. CDK 4/6 inhibitors are very effective but also costly and far from all patients respond. It is therefore very important to provide new biomarkers in order to enable best possible treatments for patients and cost effectiveness for payers. These results support our aim to provide DiviTum as a standard tool for evaluating treatments in metastatic breast- and other cancers.
It is very important to know if a therapy is effective or not. The results provide evidence for using DiviTum to give accurate prognosis and guidance regarding therapy efficacy in patients with pancreatic tumors. Our study is the first to demonstrate that a blood based marker like DiviTum can give important prognostic information to clinicians treating pancreatic cancer and become a tool for early evaluation of neoadjuvant therapy efficacy and treatment options. Additionally despite the fact that CA 19-9 is still the gold standard biomarker in pancreatic cancer, for patients with low CA 19-9 or CA 19-9 non-secretors, the S-TK assay could be an alternative screening marker.
The results presented from our collaboration with Dr Felix at the University of Heidelberg demonstrates the utility of DiviTum for precise prognosis and therapy efficacy evaluation for patients with pancreatic cancer. This builds on already published data on other tumors and provides evidence beyond our extensive trial program in breast cancer, with the aim for DiviTum to become a standard tool for predicting outcome and early efficacy evaluation for patients with specific solid tumors.
he results demonstrate that already after just 1 month of treatment, DiviTum is a highly valuable marker for clinical use regarding accurate prognosis. Throughout the course of therapy DiviTum can provide clinical information for patients with metastatic breast cancer scheduled for 1st line systemic therapy