Abviris Deutschland investors in biotech innovator are injecting a fund of €2 million to hasten its expansion. This was after it reported promising results for its immunoassay biomarker to assist early diagnosis of the neck, head, and anogenital cancers caused by human papillomaviruses (HPV).
The Abviris biomarker incorporated into its CE-marked Prevo-Check point-of-care system focuses on HPV16, the most aggressive of all HPV strains and which is responsible for over 90% of all HPV-related neck and head tumors, and more than half of cervical cancers cases.
It relies on detecting an immune response that only occurs when HPV infection has triggered tumor growth. According to the company, it is the first available blood-based test depicted to be very accurate to assist in diagnosis. In addition, the rapid flow test provides results within 20 minutes.
The company is leading the creation of more point-of-care applications for the immunoassay technology, specifically designed on the clinical requirements of other high-risk HPV types.
The CEO, Dr. Roman Niedbal said: “Abviris is on the cusp of major expansion, with this pivotal study drawing immediate attention from potential partners and clinicians keen to collaborate.”
“Prevo-Check has already been distributed to some European countries, therefore we are actively looking for global strategic partners to launch the potential of our groundbreaking technology. Many international health service providers are looking up to us because they are seeking new solutions that offer the best diagnosing efficiency, can provide cost-effective screening, and monitor the effectiveness of treatment.”
Globally, the HPV-cancer Incidences continue to rise, with neck and head cancers putting a major challenge to health budgets, as late detection leads to low survival rates. The investor vote of confidence enables Abviris to push ahead with additional, wide-ranging, clinical studies into the biomarker. These will help develop the evidence to demonstrate its effectiveness in assisting the diagnosis of a variety of different HPV clinical needs and applications.
Dr. Niedbal is a former EMEA vice president of marketing and business development for diagnostics behemoth Sysmex. He was introduced to leverage the diagnostic abilities of the new biomarker technology as the company further ventures into new geographies and plans to expand its portfolio.
He said: “We first attracted investor attention due to the scientific evidence emerging from our early research; and the belief of our founders that by taking a different technological approach we would be able to improve the early diagnosis of HPV-induced cancers.
“Their vision was to develop the first blood-based test specific enough to detect HPV cancers and also differentiate between an HPV infection and actual HPV-induced malignancy. We’ve now moved beyond that aspirational stage, actively building evidence in the clinical setting that demonstrates the potential of the Abviris solution to change outcomes for patients.”
The first part of the study reveals the effectiveness of the company’s unique HPV16 subtype-specific serological assay in the detection of head and neck cancers. Another part of the study was conducted on patients with anal cancer where the Abviris biomarker was utilized to retrospectively analyze their blood samples. It revealed that a high immune response was present before diagnosis showing the test could have the ability to detect cancer more than 9 months before the tumor becomes obvious. The immune response is determined by rising levels of a specific antibody that the Abviris assay can detect in the blood sample.
The overall study did not do a direct investigation, the findings also propose that the biomarker can differentiate between HPV-induced cancers and non-cancerous HPV infection. Future clinical trials will focus on this and the first will start early summer of 2021. Also, another study by the European multi-center seeks the confirmation of the ability of the test (after a tumor has been detected) to depict if it is caused by HPV without the need for an invasive procedure like biopsy.