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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
Anders Rylander, CEO Biovica
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
Lars Holmqvist
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,
Wing Cheng
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
Anders Rylander, CEO 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,
Karin Mattsson, Ph.D. R&D Director Biovica
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.
Anders Rylander, CEO Biovica
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.
Anders Rylander, CEO
The biomarker area is currently growing rapidly and predictive markers are in high demand by medical authorities, pharma companies and treating physicians
Peter Morsing, CEO WntResearch
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
Anders Rylander, CEO Biovica
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.
Gaia Schiavon, Medical Oncologist, Director Physician, IMED Biotech Unit at AstraZeneca
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.
Anders Rylander, CEO Biovica
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.
Dr Luca Malorni, MD, PhD, Prato Hospital, Italy.
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.
Anders Rylander, CEO Biovica
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 Nobreus, Business Development Director Biovica
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.
Anders Rylander, CEO Biovica
Local presence is important for getting closer to key customers and partners in the United States.
Anders Rylander, CEO Biovica
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
Anders Rylander, CEO Biovica
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
Dr Luca Malorni, Principal Investigator, Prato Hospital, Italy
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.
Anders Rylander, CEO Biovica
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
Dr Cynthia Ma, MD, PhD, Associate Professor of Medicine, Washington University School of Medicine, St Louis, US
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.
Anders Rylander, CEO Biovica
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.
Dr Klaus Felix, Ph.D, Department of General Surgery, University of Heidelberg
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.
Anders Rylander, CEO Biovica
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
Lisa Rydén, Professor, Department of Surgery, Lund University
The study provides key documentation for DiviTum as a tool for putative evaluation of efficacy in a peripheral blood sample and we are delighted to publish these results in collaboration with Lund University. The study results contribute towards our objective of supplying DiviTum to oncologists as a standard tool for evaluating metastatic breast cancer treatment to improve patient outcome
Anders Rylander, CEO Biovica
The 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
Lisa Rydén, Professor, Department of Surgery, Lund University
The study provides key documentation for DiviTum as a tool for putative evaluation of efficacy in a peripheral blood sample and we are delighted to publish these results in collaboration with Lund University. The study results contribute towards our objective of supplying DiviTum to oncologists as a standard prognostic and monitoring tool for evaluating metastatic breast cancer treatment to improve patient outcome
Anders Rylander, CEO Biovica.
We are pleased that Lund University sees the value of DiviTum® and has selected to use it in the study. By participating in this study, we want to help more cancer patients get the best possible treatment earlier. With DiviTum® we want to contribute to much faster treatment efficacy evaluation than what is possible with current imaging methods
Anders Rylander, CEO Biovica
“To have Biovica in the SUBLYME project as partner is highly valuable since a non-invasive biomarker like DiviTum can be a significant advantage in the development and marketing of our SUMOi. We believe that DiviTum is a very important tool in the preclinical setting, getting the drug ready for clinical studies and bringing a competitive edge”
Alfred Nijkerk, CEO of UbiQ
“The SUBLYME project received high ranking and is a promising project that have the potential to bring an important drug complemented with a biomarker for cancer patients closer to approval. The inclusion of the DiviTum technology in the project is a good example of how Swedish biotech companies can bring great value to this type of research projects.”
Dr Peter Lindberg, Program Lead EUREKA/EUROSTAR at Vinnova
The results provide guidance for using DiviTum as a test to gain early information on the response to palbociclib. We look forward to including more patients in the study and providing more evidence for DiviTum as a noninvasive assay for patients treated with CDK4/6 inhibitors
Dr Geoffrey Shapiro, MD, PhD, Director, Early Drug Development Center at the Dana-Farber Cancer Institute
These results, adding to the results presented at SABCS in December 2016, furthers strengthens the evidence that DiviTum® can indicate response to CDK4/6 treatments. Now there is evidence from cell lines, animal models, patients with breast cancer and other solid tumors including lung cancer. Going forward, we’ll continue building solid evidence of the value DiviTum® can bring to patients and health care providers.
Anders Rylander, CEO Biovica
These key recruitments strengthen our management team, secure important positions for the upcoming company IPO, and lay the foundation for a successful market introduction of our DiviTum™ biomarker assay. DiviTum™ addresses a large unmet diagnostic need. Biovica will be able to provide great value for both patients and payers
Anders Rylander, CEO Biovica
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