Ultrasensitive diagnostics for cost-effective early cancer detection

LINE Diagnostics Advances Novel Tests for Early Cancer Detection

Providence, RI – October 2025. LINE Diagnostics, a biotechnology company, announced development of a first-in-class ultrasensitive diagnostic designed for cost-effective early cancer detection. With an initial focus on ovarian and uterine cancer detection from routine Pap smear samples, LINE Diagnostics is developing a new generation of molecular diagnostics based on ultrasensitive detection of LINE-1 ORF1p, a protein uniquely expressed in cancer and its high-risk precursors but absent in normal tissue.

The Challenge: Missed Cancers in Women’s Health

Early detection of cancer saves lives. Ovarian and uterine cancers are among the most lethal malignancies in women, largely because they are discovered too late. While the Pap test prevents cervical cancer, there are no reliable screening methods for ovarian or uterine (endometrial) cancers.

A Breakthrough ‘Universal’ Cancer Biomarker

Genes make up only 2% of our genome. In contrast, 20% of our genome is comprised of hundreds of thousands of copies of the LINE-1 transposon, also known as part of the “dark genome”. LINE-1 is a virus-like genetic parasite that attempts to “copy and paste” itself in the genome. Because this activity is unhealthy, in healthy tissues, our cells keep LINE-1 silent. But in nearly all epithelial cancers, LINE-1 becomes abnormally active, producing its encoded ORF1 protein (ORF1p). The founders of LINE Diagnostics demonstrated that ORF1p is a universal hallmark of cancer, detectable pervasively across multiple tumor types and in precancerous lesions. This includes >90% of ovarian and >85% of uterine cancers and precursors.

The Technology: Single-Molecule Assays for the Pap Test

LINE Diagnostics has engineered ultrasensitive assays capable of detecting attomolar concentrations of ORF1p from biofluids. Building on three generations of single-molecule detection (Simoa and MOSAIC platforms), we are now adapting this technology to the Pap smear—a widely used, low-cost cervical cancer screen already collected in millions of women each year. Our latest assays show:

·         >90% sensitivity for gastroesophageal and pancreatic cancers in blood

·         Detection of early-stage ovarian cancer in plasma samples

·         Stability of ORF1p in common Pap test preservatives (e.g. ThinPrep), even after room-temperature storage for a month

Clinical Impact and Commercial Vision

By detecting ORF1p in the same Pap specimen already collected in routine care, LINE Diagnostics offers:

  • Non-invasive screening for deadly cancers for which there is no current effective screening method

  • Low cost and high scalability

  • Integration into existing clinical workflows without added burden

We envision our technology as the foundation for a first-in-class, low-cost, multi-cancer early detection test—starting with gynecologic cancers and extending to detection of other malignancies.

About LINE Diagnostics

Co-founded by a team of three investigators: Marty Taylor, MD PhD, Brown University Pathology, an expert in LINE biochemistry and cancer biology; David Walt, PhD, Brigham & Women’s Pathology & Howard Hughes Medical Institute, a world leader in ultrasensitive diagnostics and proven entrepreneur; and Kathy Burns, MD PhD, Chair of Pathology at Dana Farber Cancer Institute and Harvard Medical Schoool, a world leader in LINE activation and mutagenesis in cancer.