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UPPSALA, SWEDEN / ACCESS CABLE / July 30, 2022 / Biovica Internacional (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II).

Biovica, active in cancer diagnostics, today announces that the FDA has granted 510(k) clearance for the product DiviTum®TKa as an aid in monitoring disease progression in postmenopausal hormone receptor-positive postmenopausal patients previously diagnosed with cancer. from mom

“We are excited to have received formal FDA approval for our DiviTum®TKa assay, which is the first FDA-approved biomarker in this field. This is a very important milestone to realize the potential of the DiviTum®TKa product. We will now intensify our efforts to make DiviTum®TKa available for the benefit of breast cancer patients in the US before the end of this year,” said Anders Rylander, CEO of Biovica.

The approval of DiviTum®TKa is based on clinical data from the SWOG S0226 study and the so-called SWOG S0226-based clinical validation study. In the clinical validation study, the assay demonstrated excellent abilities to identify non-progressing patients with high negative predictive values, NPV, of 96.7% for progression within 30 days and 93.5% for progression within 30 days. the 60 days. This means that 96.7% of patients with DiviTum®TKa measurements below the clinical cutoff of the assay experienced no disease progression within 30 days.

Contact

Anders Rylander, CEO
Telephone: +46-18-444 48 35
Email: [email protected]

Biovica – Treatment decisions with greater confidence

Biovica develops and markets blood biomarker assays to assess the efficacy of cancer treatments. Biovica’s DiviTum® assay measures cell proliferation by detecting a biomarker in the bloodstream. The assay has successfully demonstrated its capabilities to early assess the efficacy of therapy in several clinical trials. The first application of DiviTum is to monitor the treatment of patients with metastatic breast cancer. Biovica’s vision is that all cancer patients receive optimal treatment from day one. Biovica collaborates with leading cancer institutes and pharmaceutical companies in the world. DiviTum is CE marked and registered with the Swedish Medical Products Agency. Biovica’s shares are traded on Nasdaq’s First North Growth Market (BIOVIC B). FNCA Sweden AB is the company’s certified advisor, [email protected]+46 8 528 00 399. For more information, visit: www.biovica.com.

This information is information that Biovica International is required to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons indicated above, on 2022-07-30 13:00 CEST.

Attached files

Biovica receives FDA approval for DiviTum®TKa

FONT: Biovica International

See source version at access cable.com:
https://www.accesswire.com/710322/Biovica-Receives-FDA-Approval-for-DiviTumRTKa

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