Abnova Expands its SELECT™ Non-Invasive Fetal Cell Liquid Biopsy Platform with Clinical Validation Study in Japan Sanno Hospital

Neihu, Taiwan (May 21, 2018)

Abnova announced today it is expanding its non-invasive SELECT™ fetal cell liquid biopsy platform with clinical validation study in Japan Sanno Hospital. Abnova’s SELECT™ platform uses fetal nucleated red blood cells (fNRBCs) isolated from the maternal circulation for comprehensive analysis of fetal genetic content for prenatal diagnosis. This is in contrast to the non-invasive prenatal testing (NIPT) of circulating cell-free, fetal DNA (cffDNA) in maternal plasma for common trisomies 13, 18, and 21. The use of fetal cells has been the “holy grail” of non-invasive prenatal diagnosis (NIPD) but its translation into clinical practice is hampered by the paucity of fetal-specific markers, the lack of effective cell isolation technologies, and the difficulty of integrating single fetal cell analysis with next-generation sequencing (NGS). Working unrelentingly in the last 3 years to overcome these obstacles, Abnova has developed a proprietary panel of monoclonal antibodies targeting fRNBCs, a combined positive and negative cell enrichment technology, and a NGS-based SNP analysis and sequencing. In collaboration with Dr. Michihiro Kitagawa, a renowned expert in prenatal diagnosis in Japan, the larger cohort study at Sanno Hospital will pave the road for commercializing SELECT™ as a fee-for-service, laboratory-developed test (LDT) for the prenatal market.

The current gold standard diagnostic procedures for detecting fetal abnormalities are amniocentesis performed at 15-18 weeks’ gestation and chorionic villus sampling (CVS) at 10-12 weeks’ gestation. Both tests are invasive, carry a risk of procedure-related miscarriage, and do not allow more time for abortion decision. While cffDNA NIPT performed at 9 weeks gestation can successfully identify common Trisomy 13, 18, and 21, it is not recommended for routine screening of microdeletion syndromes. Also, due to the heavily digested nature of cffDNA in the bloodstream, it cannot be used to test for the broad-spectrum, fetal monogenic disorders. Moreover, because cffDNA NIPT is only a screening test, any positive finding or negative cffDNA NIPT test needs to be followed up with a confirmatory diagnostic test. Inarguably, the implementation of cffDNA NIPT in recent years has substantially decreased the number of diagnostic procedures. However, a successfully validated fNRBC NIPD test has the potential to replace the cffDNA NIPT, aminocentesis, and CVS, and become the dominate platform for prenatal diagnosis.

Principal drivers of today’s non-invasive liquid biopsy markets worldwide are prenatal and cancer applications¹. The global cffDNA NIPT market was valued at USD 1.28 billion in 2016 and is projected to reach USD 4.99 billion by 2025, growing at a CAGR of 16.32% from 2017 to 2025². Success of cffDNA NIPT has fueled efforts in isolating circulating fNRBCs for direct non-invasive diagnosis of all fetal genetic disorders³. Such task has proven to be more technically challenging for circulating fNRBCs than for circulating tumor cells in cancer application. Nonetheless, fostered by recent advances in cell enrichment technologies, rare circulating fetal cells such as fNRBCs can be successfully isolated from the blood circulation, thereby shifting the paradigm toward a true non-invasive prenatal diagnosis, not just a prenatal screening.

1. "Liquid Biopsy Global Market - Forecast to 2024", Business Wire, March 2018

2. “Non Invasive Prenatal Testing (NIPT) Market Professional Survey Report 2018 to 2025”, Market Insights Reports, March 2018

3. “Non-invasive Prenatal Diagnosis: A Comparison of Cell Free DNA (ccFNA) Based Screening and Fetal Nucleated Red Blood Cell (fnRBC) Iniated Testing”, North American Journal of Medicine and Science, 2013