UPPSALA, SWEDEN / ACCESSWIRE / July 30, 2022 / Biovica Worldwide (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II).
Biovica, energetic in most cancers diagnostics, at this time declares that FDA has granted 510(ok) clearance for the product DiviTum®TKa as an help in monitoring illness development in beforehand identified hormone receptor constructive, metastatic postmenopausal feminine breast most cancers sufferers.
“We’re excited to have obtained the formal approval from FDA for our DiviTum®TKa assay, which is the primary FDA cleared biomarker on this discipline. It is a crucial milestone to understand the potential of the DiviTum®TKa product. We’ll now intensify our efforts to make DiviTum®TKa accessible for the advantage of breast most cancers sufferers in USA earlier than the tip of this 12 months,” mentioned Anders Rylander CEO of Biovica.
The DiviTum®TKa approval is predicated on medical knowledge from the SWOG S0226 examine and a so-called medical validation examine primarily based on SWOG S0226. Within the medical validation examine, the assay demonstrated wonderful capabilities to establish non progressors with excessive adverse predictive values, NPV, of 96.7% for development inside 30 days and 93.5% for development inside 60 days. Which means 96.7% of sufferers with DiviTum®TKa measurements under the assay medical cut-off, didn’t expertise illness development inside the subsequent 30 days.
Anders Rylander, CEO
Telephone: +46-18-444 48 35
E-mail: [email protected]
Biovica – Remedy selections with larger confidence
Biovica develops and commercializes blood-based biomarker assays to guage efficacy of most cancers therapies. Biovica’s assay DiviTum® measure cell proliferation by detecting a biomarker within the blood stream. The assay has efficiently demonstrated its capabilities to early consider remedy effectiveness in a number of medical trials. The primary utility for DiviTum is monitoring of therapy for sufferers with metastatic breast most cancers. Biovica’s imaginative and prescient is that each one most cancers sufferers will get an optimum therapy from day one. Biovica collaborates with world-leading most cancers institutes and pharmaceutical corporations. DiviTum is CE-marked and registered with the Swedish Medical Merchandise Company. Biovica’s shares are traded on the Nasdaq First North Progress Market (BIOVIC B). FNCA Sweden AB is the corporate’s Licensed Adviser, [email protected], +46 8 528 00 399. For extra data please go to: www.biovica.com.
This data is data that Biovica Worldwide is obliged to make public pursuant to the EU Market Abuse Regulation. The data was submitted for publication, via the company of the contact individuals set out above, at 2022-07-30 13:00 CEST.
Biovica receives FDA approval for DiviTum®TKa
SOURCE: Biovica Worldwide
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