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Hera Biotech Acquires HeraFem Point-of-Care Cervical Cancer Diagnostic with 91% Sensitivity

2 months ago3 min read

Key Insights

  • Hera Biotech has acquired HeraFem, a point-of-care cervical cancer diagnostic device that achieves 91% sensitivity for detecting CIN2+ lesions using electrical and optical spectroscopy with AI algorithms.

  • The acquisition expands Hera Biotech's platform beyond endometriosis to address cervical cancer, which causes approximately 350,000 global annual deaths with 94% occurring in low- and middle-income countries.

  • HeraFem eliminates the need for sample collection and provides immediate, same-visit diagnosis, addressing limitations of traditional Pap tests that have 55-80% sensitivity for detecting high-grade lesions.

Hera Biotech has acquired HeraFem, a point-of-care cervical cancer diagnostic device that delivers 91% sensitivity for detecting cervical intraepithelial neoplasia grade 2 (CIN2+) lesions and above. The strategic acquisition expands Hera Biotech's platform beyond endometriosis to address one of the world's most preventable deadly cancers.

Addressing Critical Gaps in Cervical Cancer Detection

Cervical cancer causes approximately 350,000 global annual deaths, with 94% occurring in low- and middle-income countries. Despite decades of progress in women's health screening, significant detection gaps persist. According to the U.S. National Cancer Institute, single Pap test sensitivity ranges from 55% to 80% for detecting high-grade lesions—a variability that leads to missed diagnoses, delayed treatment, and unnecessary interventions.
In the United States alone, cervical cancer drives $2.8 billion in annual costs, fueled by diagnostic delays and outdated screening methods. The acquisition addresses these challenges by providing immediate, lab-independent detection capabilities.

Revolutionary Technology Platform

HeraFem combines electrical and optical spectroscopy with AI algorithms to achieve its 91% sensitivity benchmark. The device enables immediate, same-visit diagnosis while eliminating real-world limitations including cold chain sample transport, variable pathology, delayed detection, follow-up visits, and sampling constraints.
Unlike traditional methods, HeraFem requires no sample collection, eliminating pain, cramping, spotting, and the anxiety of waiting for results. The AI-powered system continuously improves accuracy with every scan, strengthening clinical confidence and enabling more precise insights.
"For too long, time-consuming, imprecise testing methods have shaped women's health," said Somer Baburek, CEO of Hera Biotech. "Even in the U.S., over 10 million women live in healthcare deserts—proof that reliable access to accurate cervical cancer testing isn't just a global issue, it's systemic. HeraFem eliminates location barriers, reduces misdiagnoses, and delivers the clarity women deserve—from rural Mississippi to remote Guatemala and beyond—with scientific precision and diagnostic equity."

Commercial Expansion Strategy

The acquisition positions Hera Biotech to capitalize on the $12 billion market shift toward precise, point-of-care solutions. The company has secured distribution partners and pre-orders across Central and South America, with U.S. regulatory pathways currently underway.
"HeraFem closes persistent gaps in cervical cancer detection—speed, sensitivity, access, and patient experience," said Teo Tijerina, CEO of Hera Diagnostics. "Integrated into Hera Biotech's platform, it scales fast, precise, affordable care—cementing HeraFem as a cornerstone in tackling one of the toughest challenges in women's health."

Expanding Diagnostic Portfolio

Hera Biotech's platform now includes both MetriDx, the first non-surgical test for definitive endometriosis diagnosis and staging, and HeraFem. The company describes itself as a commercial-stage organization redefining non-invasive diagnostics in women's health with clinically validated tools engineered for scalability.
The company is currently raising a bridge round to accelerate commercial scale as it expands its point-of-care diagnostic capabilities across key global markets. The acquisition represents a strategic move to provide lab-quality accuracy at the point of care, enabling faster answers, better outcomes, and worldwide availability for women's health diagnostics.
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