Biovica CLIA Lab achieves New York State permit that opens the entire US market
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Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
Biovica, active in blood-based cancer monitoring, today announces that the company has obtained an out-of-state permit allowing Biovica to offer testing to patients in New York State. Together with previous permits, Biovica is now allowed to offer DiviTum® TKa in all 50 states in the US and Puerto Rico.
The permit was granted by the New York State Department of Health after a rigorous review process. With this approval, healthcare providers and patients in New York can now access DiviTum® TKa through Biovica’s lab in San Diego. New York State is the fourth most populous state in the country, housing more than 20 million people.
"The permit not only confirms the high degree of quality and compliance of our lab with regulatory requirements, but it also opens new opportunities in this important market – New York State has many potential patients and multiple leading medical centers. We are very proud that patients and their doctors across the entire US are now able to use DiviTum’s help in their breast cancer treatment.", said Anders Rylander, CEO of Biovica
Contact
Anders Rylander, CEO
Phone: +46 76 666 16 47
E-mail: anders.rylander@biovica.com
Anders Morén, CFO
Phone: +46 73 125 92 46
E-mail: anders.moren@biovica.com
Biovica – Treatment decisions with greater confidence
Biovica develops and commercializes blood-based biomarker assays that help oncologists monitor cancer progression. Biovica’s assay, DiviTum® TKa, measures cell proliferation by detecting the TKa biomarker in the bloodstream. The assay has demonstrated its ability to provide insight to therapy effectiveness in several clinical trials. The first application for the DiviTum® TKa test is treatment monitoring of patients with metastatic breast cancer. Biovica's vision is: “Improved care for cancer patients.” Biovica collaborates with world-leading cancer institutes and pharmaceutical companies. DiviTum® TKa has received FDA 510(k) clearance in the US and is CE-marked in the EU. Biovica's shares are traded on the Nasdaq First North Premier Growth Market (BIOVIC B). FNCA Sweden AB is the company's Certified Adviser. For more information, please visit: www.biovica.com