We are very pleased to collaborate with Mayo Clinic in our ambition to further strengthen our already solid documentation of the value DiviTum® can bring to patients being treated for metastatic breast cancer. This collaboration complements our previous studies in this field and will be important in our market introduction of DiviTum® as a tool for the monitoring of patient response to treatments within metastatic breast cancer
As DiviTum® is approaching commercialization we are strengthening the team. Robert brings insights from cancer diagnostics as well as therapeutics and has an excellent track record of successful product launches which will be valuable when launching DiviTum®. The appointment of Robert is an important step in bringing DiviTum® to the US market, for the benefit of cancer patients
While great progress has been made in developing new therapies for cancer, there are still sizable gains to be made in better understanding how well a therapy is working during the course of treatment. With pioneering work on cell proliferation markers, Biovica is at the forefront of those improvements. I am excited to be a part of the team. So far, DiviTum® has shown great results in clinical studies, and I am confident it can help clinicians make more informed decisions, so patients get the best possible treatment.
Our study shows that DiviTum can provide additional information on prognosis and therapy efficacy in women with metastatic breast cancer treated with today's standard therapies. For me as an oncologist, this means that I can get complementary information on the development of the disease that can influence treatment decisions with the goal of better outcome and quality of life for the patient. We are interested in continuing to evaluate DiviTum for women with metastatic breast cancer in larger studies
The study is a strong confirmation of previous studies in metastatic breast cancer. DiviTum has been used in seven published studies in more than 1,000 breast cancer patients. The study in Lund shows that DiviTum can be used as an independent prognostic tool in this indication. The goal for Biovica is for DiviTum to become a standard tool for evaluating treatment efficacy in patients with metastatic breast cancer,
We are pleased with our results in the analytical validation, which is part of our FDA application and so far meet the criteria we have set. However, a component supplier has had delivery delays which means that we now anticipate being able to submit the FDA application a little later than previously expected
We are very pleased that these results, which were initially presented at the AACR annual meeting 2019, are published in the renowned journal Clinical Cancer Research. The data shows that DiviTum® can be used to evaluate the treatment efficacy of a CDK 4/6 inhibitor in metastatic breast cancer. This data is an important part of our clinical efficacy data. DiviTum® has been evaluated in more than ten studies including more than 1 700 breast cancer patients.
The results from these studies provide the first evidence for DiviTum® as a biomarker of efficacy of palbociclib in metastatic breast cancer and build upon prior evidence in the pre-operative setting. The results need confirmation in larger, ongoing studies, and are encouraging in terms of clinical value. Via this blood test we can potentially identify which patients will not have a benefit from these new treatments and should ideally be selected for alternative regimens.
Henrik possesses a rare combination of scientific expertise and commercial experience. With his many years of diagnostics background, he brings with him tremendous insight and an extensive network of contacts. Henrik is an important piece of the puzzle in Biovica's continued market expansion
For a decade, Companion Diagnostics i.e. patient stratification for the right individualized treatment has been the focus of the industry. Now, the next very important topic to secure safe and effective treatments within personalized cancer medicine is the monitoring of patient response to therapy. Biovica is in a strong position with its DiviTum test which provides a unique tool to oncologists that allows for a fast, robust and reliable assessment of patients’ response to a given treatment. DiviTum really has a great potential as it is already CE marked, has interesting applications, support from key opinion leaders globally and several excellent clinical study results. The pieces are in place to take Biovica to the next level.
The results from two additional studies with DiviTum® will be presented at San Antonio Breast Cancer Symposium, the world's largest scientific conference on breast cancer
We are thrilled to see these new, interesting results. It demonstrates that pre-operative DiviTum values measured in serum is a strong prognostic marker in operable breast cancer with a potential to identify patients with the most aggressive tumors in order to personalize their therapy,
Dr Malorni’s research group has managed to show prognostic effect in a large cohort of women with operable breast cancer. This gives us high expectations on DiviTum’s potential beyond monitoring of treatment for patients with metastatic breast cancer, which is our first application for DiviTum.
We have showed the clinical validity of DiviTum in an adequately designed prospective trial of combined targeted and endocrine therapies. We are encouraged by these promising results showing the potential of DiviTum to become a clinically useful dynamic biomarker for monitoring efficacy of palbociclib and endocrine therapy in patients with metastatic breast cancer
We are proud to present great new DiviTum results in collaboration with globally renowned Institut Curie. The data presented in the study by Dr Luc Cabel and his colleagues constitute further important validation of DiviTum’s capacity to monitor therapy efficacy in women with metastatic breast cancer. It supports the results from the TREnd study presented earlier this year, and our high expectations on DiviTum to become a standard biomarker in metastatic breast cancer. With DiviTum we want to contribute to improved patient outcome
I look forward to start working for Biovica and DiviTum. I am impressed by how far the company has come in developing the product, collaborations with leading oncologists and the results that have come from these collaborations. I look forward to contributing to the approval of DiviTum so that it can be used to contribute to better treatment for cancer patients in the world
The renewal of the certificate is important for Biovica as it proves that our quality management system fulfills the global quality requirements. The quality management system is a pre-requisite for market approval in both US and Europe and hence a must in order for Biovica to fulfill the vision of contributing to best treatment for cancer patients.
I look forward to attend the congress and present DiviTum® to this audience of professionals. I will highlight the unique data we have with DiviTum® as a tool for effective pre-clinical evaluation of candidate drug effects all the way to large clinical trials demonstrating the unique capability of DiviTum® to provide accurate prognosis and quick evaluation of cell-cycle regulating drugs. With increased focus on targeted therapies, there is a need for good biomarkers, and I am excited to be invited to the congress to contribute to the discussion regarding biomarkers in oncology drug development and clinical validation
The Biomarker congress is an excellent opportunity for us to engage with the pharmaceutical industry and highlight how DiviTum® can contribute to a more effective drug development process and be a useful tool for management of new targeted oncology therapies, supporting our aim to improve cancer patients outcome
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,