Biovica submits CLIA lab application for DiviTum®TKa launch
Biovica today announces that the company has submitted its CLIA lab application, marking yet another significant milestone for the US commercial launch of the recent FDA cleared test DiviTum®TKa. Biovica is now prepared to receive, analyze, and report results for its novel DiviTum®TKa diagnostic with capacity and capability to process samples nationwide.
“We are excited to make this submission for our CLIA lab certification for our new lab facility in San Diego, California. The submission for our CLIA application is a final, critical step to bringing this product into the US market and we look forward to launching DiviTum®TKa before year-end in USA,” said Warren Cresswell, President of the Americas at Biovica.
About DiviTum®TKa DiviTum®TKais an in vitro diagnostic device intended for the semi-quantitative measurement of thymidine kinase activity (TKa) in human serum. The assay is to be used as an aid in monitoring disease progression in previously diagnosed hormone receptor positive, metastatic postmenopausal female breast cancer patients.
DiviTum®TKadetermines the enzymatic activity of thymidine kinase (TK) in human serum samples through technology that enables the assay to measure TK activity with high sensitivity. Biovica is currently engaged in several clinical studies to generate high-quality clinical data on the performance of DiviTum®TKawithin different solid tumor types and cell-cycle regulating drugs.
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. For more information please visit: www.biovica.com.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
The _ga cookie, installed by Google Analytics, calculates visitor, session and campaign data and also keeps track of site usage for the site's analytics report. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors.
This cookie is installed by Google Analytics.
A variation of the _gat cookie set by Google Analytics and Google Tag Manager to allow website owners to track visitor behaviour and measure site performance. The pattern element in the name contains the unique identity number of the account or website it relates to.
Installed by Google Analytics, _gid cookie stores information on how visitors use a website, while also creating an analytics report of the website's performance. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously.
Hotjar sets this cookie to detect the first pageview session of a user. This is a True/False flag set by the cookie.
Hotjar sets this cookie to identify a new user’s first session. It stores a true/false value, indicating whether it was the first time Hotjar saw this user.
Hotjar sets this cookie to know whether a user is included in the data sampling defined by the site's pageview limit.
Hotjar sets this cookie to know whether a user is included in the data sampling defined by the site's daily session limit.