WILMINGTON: Lisen Imprinting Diagnostics (LisenID) announces an innovative and revolutionary epigenetics-based diagnostic method for thyroid cancer detection. The clinical research was published in the Journal of Clinical Oncology (JCO), a high-impact, peer-reviewed medical journal of the American Society of Clinical Oncology (ASCO).
The study leverages LisenID’s QCIGISH (Quantitative Chromogenic Imprinted Gene In-Situ Hybridization) technology which can intuitively translate the aberrant expression status of cancer-related imprinted genes into visualized signals in the nuclei thereby allowing the objective clinical quantification of cancer cell expressions.
Due to improved imaging systems, there has been a dramatic increase in the number of people diagnosed with nodules on their thyroids. Around 70% of the adults have ultrasound-detectable thyroid nodules but only 5% of them are malignant. When a nodule is detected through an ultrasound scan, the physician will take a fine needle biopsy to determine if it is malignant. Often 20-30% of the biopsies are insufficient to give a definite diagnosis, which will lead to missing early-stage cancers; there is also a 2-10% false positive rate that can result in unnecessary surgeries. Patients who get indeterminate diagnoses will have to wait for months and undergo repeated biopsies before getting reassessed – causing unnecessary anxiety and losing opportunity for early treatment.
In the current study, LisenID’s AI was collectively trained and validated using biopsies from 550 patients. The QCIGISH test had a sensitivity of 100% and also could identify true negative biopsies 100% of the time. This will allow physicians to identify whether a thyroid nodule is malignant early on while confidently excluding patients from needing unnecessary surgery or treatment.
Dr. Tina Cheng, LisenID’s Co-Founder and technology inventor remarked, “It is very exciting to see our work being clinically translated into a new diagnostics for cancer. We believe that our thyroid study, now published after peer review in a high-impact journal, validates our approach, which we also are developing for a range of cancers including lung, bladder and others.”
The paper’s corresponding author, Dr. Michael Xing, the Director of the Johns Hopkins Thyroid Tumor Center, and Lab Chief for Cellular and Molecular Thyroid Research at the Johns Hopkins University School of Medicine, added, “This novel assay for imprinted gene biomarkers may have a considerable impact in the clinical diagnosis of malignant thyroid nodules. Furthermore, LisenID’s technology promises to revolutionize early detection of thyroid cancer and holds great potential for doing the same for a wide variety of other cancers as well.”