Biovicas blodbaserade biomarkörtest DiviTum TKa är godkänt av FDA via 510(k)-förfarandet. Det används av läkare som ett kliniskt stöd för att följa sjukdomsförloppet hos patienter med hormonreceptorpositiv metastaserad bröstcancer. Istället för att säljas som ett traditionellt kit levereras testet som en tjänst direkt från bolagets amerikanska anläggning.
Den federala CLIA-certifieringen garanterar att den diagnostiska testningen uppfyller mycket stränga kvalitetskrav. Detta skapar en smidig process där en ny kund omedelbart kan börja skicka in prover, utan att behöva bygga upp en egen testkapacitet på plats.
Dubbelspårig amerikansk expansion
Biovicas tillväxtstrategi i USA vilar på två ben. Det ena utgörs av samarbeten med läkemedelsutvecklare, vilka använder testet för att följa tumöraktiviteten i sina kliniska studier. Det andra spåret går via sjukvården, där en breddad användning på sjukhus och cancercenter gradvis bygger upp en löpande och stabil provvolym.
Det aktuella avtalet riktar in sig specifikt på den kliniska marknaden. I grunden rör det sig om ett ramavtal som fastställer pris och tillgång till laboratoriet. Det ger centret full flexibilitet att beställa tester utifrån behov, helt utan krav på förutbestämda volymer.
Q&A med vd
Theis, an NCI-designated Comprehensive Cancer Center represents the highest standard of cancer care in the US and is a highly demanding customer to win. What tipped the balance in favour of bringing DiviTum TKa into their workflow?
– Comprehensive Cancer Centers set a high bar because they’re evaluating the evidence, not just the convenience. What moved this forward was the combination of the FDA clearance, the published clinical utility data in HR+ metastatic breast cancer, and the fact that we deliver this as a CLIA lab service rather than asking them to validate a kit internally. For an academic center, that removes the operational burden and their oncologists get a result they can act on without the center having to build any testing capability of its own
The agreement sets a framework rather than a fixed volume. What needs to happen now for it to translate into regular testing?
– The framework gives us pricing and lab access, now it’s about workflow integration. That means getting DiviTum TKa built into how oncologists actually order tests day to day, and making sure the breast oncology team is trained and comfortable ordering it as standard of care. We’ve seen this work well at other accounts, where the test becomes part of the standard order set rather than a special request, and we track utilization at our more established centers as the benchmark for what a fully ramped account looks like.
How does adoption at a leading academic centre feed into your wider commercial push across US oncology?
– Academic centers set the standard the rest of the market watches. A Comprehensive Cancer Center adopting DiviTum TKa is a strong reference point when we’re in conversations with other hospitals and IDNs, it signals that the test holds up under the scrutiny of a top-tier institution. It also strengthens the clinical evidence base and physician familiarity that feeds our second track, drug developers, since trial investigators are often based at exactly these kinds of centers. That’s on top of the volume itself: every center we add builds the everyday testing base that’s central to our clinical-market strategy
Where does this deal point Biovica’s US priorities over the next year?
– The priority is scaling both tracks in parallel, deepening adoption at flagship accounts like this one while expanding into IDNs where we can reach many oncologists through a single relationship. We’re focused on converting framework agreements into steady ordering volume, and on making DiviTum TKa a routine part of how HR+ metastatic breast cancer is monitored, not a one-off order. Beyond the clinical side, this reflects a broader shift in how we’re investing in the US. We’ve been moving key functions from Sweden closer to our US operations, reflecting the fact that the US is now our primary commercial growth engine. And on the pharma side, we’ve recently announced a number of new biomarker collaborations, several with US drug developers, but also with partners in Europe and Asia which shows that the momentum we’re building in the clinic is being matched by growing interest in DiviTum TKa as a biomarker across the industry more broadly, not just in the US.
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