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Cutting-edge Molecular Diagnostics for Early Disease Detection

The molecular diagnostics team is dedicated to pioneering projects aimed at creating innovative diagnostic platforms. Our current focus is on advancing early disease detection and point-of-care diagnosis through the development of rapid, ultra-sensitive, and portable nucleic acid/aptamer/protein biosensors for analyzing bodily fluid biomarkers. Our activities include developing electrochemical sensors and prototypes for point-of-care diagnosis, as well as ultrasensitive biosensor development, coupled with clinical validation of diagnostic assays. These platforms are designed to address unmet bioanalytical, medical, and molecular diagnostics needs, offering label-free, cost-effective, rapid, reprogrammable, multiplexed, and ultrasensitive capabilities.
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Notable Achievements

Giner, Inc. consistently engages in a wide range of projects, including the development of aptamers and nucleic acid-based electrochemical and other biosensors. Among our notable achievements is the aptamer-based multiplexed detection of opioid metabolites in wastewater samples, boasting a detection limit of 27 pg/mL. This groundbreaking work was co-published in ACS Nano (2022) and highlighted in Science Daily, Boston College. Additionally, our team at Giner has made significant progress in detecting multiple gene biomarkers (CYP2D6 and CYP2C19 and their allele variants) associated with drug metabolism and in non-invasively detecting oxytocin peptide at 1 pg/mL in saliva (published in International Journal of Molecular Sciences, 2023), blood, and hair extract samples. Our research also extends to the development of fungal gene sensors, achieving an impressive limit of detection equivalent to 10 copies/mL for Histoplasma genes, including CBP1, M-antigen, and HCP100, as published in Biosensors and Bioelectronics in 2023.

Furthermore, we have advanced the non-invasive detection of cancer gene mutations and personalized therapy for non-small cell lung cancer (NSCLC). Giner’s PCR-enhanced ligation assay delivers genomic DNA sensitivity down to 2 copies/µL, corresponding to mutation allele frequency (MAF) levels of 0.01%. This fulfills the clinical sensitivity requirement and surpasses the sensitivity of the current standard digital droplet PCR (ddPCR) by 10-fold, which has a limit of 0.1% for MAF. Ongoing work aims to adapt the assay for multiplexed ctDNA detection, validate with patient plasma samples, and integrate into a prototype, thus achieving a significant milestone toward regulatory evaluation. Fully developed, this technology will facilitate the enactment of personalized therapy, improve treatment outcomes, and offer significant advantages over existing methods such as lower test cost, easier sample preparation, and faster sample-to-result turnaround.


Patent Applications

  • AA Argun, M Rana, “Detection of Oxytocin in a Biological Sample” U.S. Patent App. 63/448,878 (Feb 28, 2024)

Conference Abstracts

  • M. Rana, S.M. Asil, C. Boutin, M.J. Kachwala, J. Espejo, A.A. Argun (PI) “Detection of EGFR mutations T790M and L858R for therapeutic guidance of NSCLC” 2024 World Conference on Lung Cancer (Control/Tracking # 2024-RA-2397-WCLC), September 7-10, 2024, San Diego, CA, USA.
  • Shima M Asil, PhD, Chia-Yi (Jobert) Hsiao, MS, Pengfei Xie, PhD, Avni A Argun, PhD, Muhit Rana, PhD (PI) “Rapid and Reprogrammable Assay for Multiplexed Gene Detection” 2024 MHSRS (Abstract ID: MHSRS-24-13209), August 2024, Kissimmee, FL, USA.