Bio-Me AS Appoints Dr. Davide Manissero to Board of Directors to Accelerate Women’s-Health Diagnostics Strategy

Bio-Me developing next-generation, microbiome based molecular diagnostics in Women's Health

OSLO, NORWAY, November 12, 2025 /EINPresswire.com/ -- Bio-Me AS, a microbiome company pioneering Precision Microbiome Profiling (PMP™) and building a pipeline of microbiome-based molecular diagnostics for women’s health, today announced the appointment of Dr. Davide Manissero, MD, to its Board of Directors.

Dr. Manissero is a physician-executive whose career spans clinical medicine, global public health, and senior leadership roles across the IVD and pharmaceutical sectors. He previously served as Chief Medical Officer at QIAGEN, where he led global medical, regulatory, and clinical affairs and supported the company’s COVID-19 diagnostics response; he is currently Vice President and Chief Medical Officer at Radiometer (a Danaher company), providing medical oversight to acute and critical-care diagnostics. He has also held leadership roles at ECDC (Respiratory Infections/TB) and served as a Medical Officer for the WHO in South-East Asia, with a focus on tuberculosis, infectious diseases, AMR, and outbreak preparedness.

“Davide’s blend of bedside and boardroom experience is exactly what Bio-Me needs for the next phase,” said Arne Materna, PhD, CEO of Bio-Me AS. “As we expand from a premier microbiome profiling service into women’s-health molecular diagnostics—with solutions designed to deliver actionable, clinically relevant insights—his track record in clinical evidence generation, regulatory strategy (FDA/IVDR), and medical adoption will help us move faster and de-risk execution.”

“I’m delighted to join Bio-Me at this pivotal moment,” said Dr. Davide Manissero. “Microbiome-driven diagnostics are poised to close longstanding gaps in women’s health. Bio-Me’s PMP™ platform—with its focus on short turnaround time and absolute quantification of targeted microbial signatures—offers a compelling path from analytical rigor to clinical utility. I look forward to working with the team to shape robust clinical validation, regulatory pathways, and real-world adoption.”

Advancing Bio-Me’s Women’s-Health Diagnostic Focus:
Bio-Me, is a leading provider of fast, accurate, and cost-effective microbiome analysis solutions for hard-to-analyze skin and vaginal microbiome samples. The Oslo, Norway-based company is leveraging its proprietary PMP™ technology and service laboratory footprint to develop next-generation, microbiome-based molecular diagnostics that address high-burden conditions in women’s health, where current standards of care leave actionable blind spots. The company’s near-term priorities include:
• Clinical evidence programs to correlate quantified vaginal microbiome signatures with diagnosis, risk stratification, and treatment guidance;
• Regulatory strategy and quality systems aligned with EU IVDR and U.S. pathways; and
• Medical affairs engagement with clinicians, guideline bodies, and payers to support responsible adoption and reimbursement.

Dr. Manissero’s board appointment strengthens Bio-Me’s capabilities across clinical affairs, regulatory navigation, post-market vigilance, and health-system adoption—competencies he has built and led in prior roles.

About Dr. Davide Manissero:
Dr. Manissero MD, MSc, MRCPCH, DTM&H is a medical doctor and diagnostics leader with expertise spanning infectious diseases, sepsis, emerging pathogens, and AMR. His background includes executive roles at QIAGEN (CMO), Radiometer/Danaher (VP & CMO), leadership at ECDC (Head of Respiratory Infections/TB), and a WHO medical officer posting in Indonesia. He has guided multiple FDA EUAs, 510(k) clearances, and IVDR portfolio transitions, and served in academic and advisory roles, including Honorary Senior Lecturer at UCL.

About Bio-Me AS:
Bio-Me AS is a Norwegian microbiome company delivering Precision Microbiome Profiling (PMP™) services and developing microbiome-based molecular diagnostics with a particular focus on women’s health. Bio-Me partners with healthcare providers, life-science companies, and researchers to translate microbial insights into actionable medical information.

Media Contact:
info@bio-me.com | +47 21 09 03 02

Arne Materna
Bio-Me AS
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