#NewAseBioMember | “AseBio likely serves as an essential platform for industry collaboration, innovation support, and regulatory guidance in Spain’s biotech sector”

AseBio. What does your company's work bring to the table and what is its strength?

Yara Aceta. Bioherent is a deep-tech SME specializing in next-generation in-vitro diagnostics for accurate drug allergy identification. At the forefront of integrated photonics-based diagnostics, Bioherent is pioneering a label-free technology that is set to revolutionize clinical diagnostics, much like it did in the telecommunications industry. Originally developed for high-speed data transfer in fiber-optic communications, integrated photonics enabled the miniaturization of optical components, enhancing speed, efficiency, and cost-effectiveness. Bioherent is now translating these advancements into healthcare, developing a new generation of diagnostic tools that redefine accuracy and accessibility.

The company’s core strength lies in its AllerWAVE™ technology, which integrates photonic biosensors and advanced surface chemistry to deliver highly accurate, fully automated, and rapid diagnostic solutions. Unlike traditional methods such as ELISA and CLIA, AllerWAVE™ offers accuracy, significantly lower reagent costs, and eliminates the need for specialized personnel. Moreover, it delivers results up to four times faster than the current market benchmark (ImmunoCAP® by Thermo Fisher), making it an ideal solution for urgent care and pre-operative settings.

Bioherent’s AllerWAVE™ technology is not just a breakthrough for drug allergy diagnostics—its core technological principles make it highly adaptable to a wide range of biomedical applications. The integrated photonics platform, combined with label-free detection and advanced surface chemistry, allows for precise biomarker identification across different fields.

By modifying the surface chemistry of the photonic biosensors, Bioherent’s technology can be easily adapted to detect different types of biomolecules, making it a versatile platform for in-vitro diagnostics beyond drug allergy testing. This opens the door to other high-impact applications, such as:

• Immunotherapy Monitoring – Tracking the response of patients undergoing cancer immunotherapy by detecting anti-drug antibodies (ADAs) that may reduce treatment efficacy.
• Infectious Disease Diagnostics – Providing fast and accurate detection of viral or bacterial infections without the need for complex lab-based testing.
• Autoimmune Disease Diagnostics – Enabling precise detection of autoantibodies, which play a critical role in diseases like rheumatoid arthritis, lupus, and multiple sclerosis.
• Sepsis and Acute Inflammatory Response Detection – Offering real-time monitoring of inflammatory markers, crucial for early sepsis detection and preventing severe complications.
• Personalized Medicine & Therapeutic Drug Monitoring – Measuring drug concentration and patient-specific responses to optimize treatments, particularly in oncology and chronic disease management.

The adaptability of Bioherent’s integrated photonics technology positions it as a next-generation platform that can redefine diagnostics across multiple medical disciplines. By offering accuracy, rapid results, and accesibility, it paves the way for decentralized diagnostics, empowering healthcare providers with real-time, actionable insights at the point of care.

AseBio. What is AseBio for you?

Yara Aceta. AseBio likely serves as an essential platform for industry collaboration, innovation support, and regulatory guidance in Spain’s biotech sector. Being part of AseBio could provide networking opportunities, access to funding, and a stronger voice in shaping industry policies.

AseBio. When did you first hear about AseBio?

Yara Aceta. As a biotech spin-off from the University of Malaga, Bioherent has likely been engaged with biotech industry associations and innovation networks from its early stages (since its founding in 2021).

AseBio. What do you expect from being part of an association like AseBio?

Yara Aceta. Bioherent would expect several benefits from AseBio, including:

• Increased visibility within the biotech and investor community.
• Support for regulatory challenges, particularly regarding IVDR compliance for in-vitro diagnostics.
• Access to partnerships and funding opportunities for scaling up and commercializing its technology.
• Collaboration with industry leaders to promote innovation in diagnostics and address critical challenges in the healthcare sector.

AseBio. What is the biggest challenge facing the biotech sector or your company?

• For the biotech sector: Funding and regulatory hurdles are major challenges. Deep-tech biotech startups require long development cycles, high R&D costs, and significant regulatory approvals, making it difficult to attract investment.
• For Bioherent: The biggest challenge is achieving regulatory certification (CE marking under IVDR) and market penetration. The company must complete clinical trials, secure IVDR approval, and establish distribution partnerships to reach commercialization. Additionally, hiring experienced industry professionals to complement its highly technical team is a key challenge for scaling operations.