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Liquid Biopsy-based Detection of Early Stage Gynecological Cancers

C.E. Credits: P.A.C.E. CE Florida CE
Speaker
  • Chief Scientific Officer Aspira Women's Health
    Biography

      As Chief Scientific Officer, Dr. Lesley Northrop leads Product Innovation and Research and Development activities as they translate to clinical diagnostic test development. Dr. Northrop has been working in molecular genetics for 20 years in academic research labs, private and large hospital clinical practices and genetic commercial companies predominately focused on female reproductive health. At Aspira Women's Health Dr. Northrop is focused on building and leading a team of highly skilled individuals able to support the business in its ambitious goals. Dr. Northrop is responsible for overall business innovation and proactively explores new technologies.



      Dr. Northrop specializes in developing new technology as it translates from research to a clinical diagnostic test.  She has built 4 brand-new clinical molecular genetics laboratories for NYS CLIA/CAP- accreditation during her career and is an expert in LDT design and validation predominately using NGS technologies. She also has extensive expertise in developing clinical assays for commercial offerings.



      She also serves as a Laboratory Director of Aspira's Molecular Genetics Laboratory, holds a NYS CQ in molecular genetics and CA-CPDH and NJ Bioanalysis Director license.  She obtained her MSc/Ph.D. from Boston University and conducted her American Board of Genomics and Genetics Fellowship (ABMGG) training at Columbia University in Clinical Cytogenetics and Molecular Genetics. She is boarded and a fellow of ABMGG in Molecular Genetics.



      Prior to joining Aspira Women's Health Dr. Northrop was SVP of Clinical Genetics and Clinical Molecular Genetics Laboratory Director with Celmatix. She also was also formerly Clinical Molecular Genetics Laboratory Director at Fresenius Medical Care North America. Dr. Northrop began her journey working on species survival of endangered animals all over the world primarily in captive and wild Giant and Red Pandas. She then entered into the human infertility field as her first post-doctoral fellow to help build a clinical molecular genetics lab at one of the largest IVF centers in the country (RMA-NJ). During that time, she helped develop single cell-based technologies for the detection of aneuploidy, translocations, and implementation of monogenic disorder screening in preimplantation embryos. This changed the face of IVF technology for preimplantation genetic testing (PGT) to a more comprehensive method with higher sensitivity and specificity.


    Abstract

    According to the American Cancer Society, in there were an estimated 110,070 new cases diagnosed and approximately 32,120 deaths from gynecologic cancers in the U.S. in 2018. Of the five most common types of gynecologic cancer (cervical, ovarian, uterine, vaginal, and vulvar), ovarian cancer is associated with the highest mortality rate and is the fifth leading cause of cancer death. With the exception of pap smear for cervical cancer, there is no specific screening test for any gynecologic cancer. If detected early, mortality rate of ovarian cancer can be reduced by as much as 90% and this presents a huge unmet need. Among many potential biomarkers, circulating tumor DNA (ctDNA) has emerged in the last few years as a major tool for precision medicine in oncology. ctDNA exhibits genetic and epigenetic alterations from its cell of origin and is therefore becoming a key biomarker in non-invasive early detection using liquid biopsy. In this talk, I will highlight several challenges that still exist, despite rapid progress, in widespread clinical usage of ctDNA for cancer screening, notably for the early detection. These include limited sensitivity of current technology to detect small tumors with very low levels of mutant ctDNA present, a priori unknown somatic mutations and inability to distinguish ctDNA from cfDNA from normal cells released by non-malignant cells during normal cellular turnover. I will also review some of the techniques that are being used to overcome these challenges such as ultra-deep next-generation sequencing, customized bioinformatics tools and, machine learning to build classification models by integrating multiple analytes (such as proteins, transcriptome, miRNA and exosomes). I will conclude by providing a brief commentary on the future prospects of this promising technology.

    Learing Objectives:

    1.    What is the current level of detection (LOD) for mutant allele fraction that most liquid-biopsy technologies/test can offer? A: 0.5%

    2.    What is the challenge of using a larger sequencing panel for the detection of ctDNA? A: requires a greater input of DNA and higher sequencing costs due to lower throughput of sample


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