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Singlera Genomics Joins Forces with Yale Researcher for "A More Efficient and Cost Effective Fetal Cell Free DNA Quantification Method" Study

SAN DIEGO, Calif., Jan. 25, 2016 /PRNewswire/ -- Singlera Genomics Inc., a startup company focusing on non-invasive genetic testing, today announced the signing of a Clinical Trial Agreement with a research team led by Professor Michael J. Paidas, MD of Yale School of Medicine. Paidas will partner with Singlera on evaluating a Singlera's proprietary technology for non-invasive prenatal testing of chromosomal aneuploidy and simultaneous measurement of fetal DNA fraction in a single test. This new method has the potential to significantly lower the cost of a cfDNA test, reduce false negative rate, and cut down the turnaround time to 1-2 days.

Singlera was selected for the study because of its comparative performance to other technologies in preliminary studies.

Background of the Study

The American College of Obstetricians and Gynecologist recommends that all pregnant women, regardless of age, be offered prenatal screening or invasive testing for chromosomal abnormalities at <20 weeks' gestation. (1)  The predominant aneuploidy screening consists of combining biochemical analytes with ultrasound measurement of the fetal nuchal translucency (2)  Invasive prenatal diagnostic procedures consist of amniocentesis (withdrawal of amniotic fluid) and chorionic villus sampling

Recently, cell free DNA (cfDNA) screening, which is also called cfDNA testing, noninvasive prenatal testing, noninvasive prenatal screening, has offered a new noninvasive screening strategy for aneuploidy and other fetal genetic disorders.  There are different platforms in use at various laboratories that evaluate cfDNA. 

The accuracy of cfDNA for the common trisomies of interest (13, 18, and 21) and sex chromosomal abnormalities varies by the condition and platform used. 

More false-positive results are expected in women who are at low risk or when screening is done for very rare conditions. While cfDNA is a promising aneuploidy screening method, there are pitfalls.  Approximately 0.8-8% of cfDNA cases will result in "no results".  The current recommendation is to consider diagnostic invasive testing on all cases where a non-reportable result is obtained on cfDNA screening. A major practical concern is emerging regarding implementation of cfDNA screening in the present day obstetric population, namely the obesity epidemic.  Low fetal fraction has been consistently been reported with increasing maternal weight. "Having a reliable screen for patients with increased body mass index would be transformative and significantly decrease invasive testing in this population," said Paidas. "The decreased turnaround time and lower cost would make this screen even more appealing."

Despite several concerns and unresolved issues regarding cfDNA implementation, cost effectiveness data suggest that for the general pregnancy population, cfDNA will identify 15% more trisomy cases, reduce invasive procedures by 88%, and reduce iatrogenic fetal loss by 94%, as compared to first trimester screening.

It is reasonable to anticipate that cfDNA screening will eventually be offered to less than ideal candidates, such as the 'low risk population'. Hence, having a faster, more accurate cfDNA screening method which can perform well in the obese population in particular, would be highly advantageous.

About Singlera

Singlera Genomics Inc. is a startup company based at La Jolla, California, (505 Coast Blvd S, La Jolla, CA 92037) co-founded by Dr. Yuan Gao (faculty on-leave from Johns Hopkins University) and Dr. Kun Zhang (Associate Professor at UCSD) in June 2014. Dr. Gao has made critical contributions to the initial development of the non-invasive T21 test currently adopted by most existing tests.  Dr. Zhang has been on the forefront of method development related to single cells and single-molecule DNA sequencing. Several inventions from the Zhang lab have been exclusively licensed to Singlera Genomics. Recently, Singlera Genomics developed a proprietary method for trisomy (T13, T18, T21) detection at a lower cost and faster turnaround time compared with the existing commercial tests. Importantly, this method can reliably estimate the fetal DNA fraction (both male and female fetus) and detect chromosomal abnormalities within one single test.  It has the potential to significantly lower the cost for cfDNA test, reduce false negative rate, and cut down the turnaround time to 1-2 days.

Contacts

Singlera Genomics Inc.
Qiang Liu, 858-459-0832      
[email protected]

Yale School of Medicine
Michael J. Paidas, MD
Professor & Vice Chair, Obstetrics
Program Director, Maternal-Fetal Medicine Fellowship
Director, Yale Women and Children's Center for Blood Disorders and
Preeclampsia Advancement
Department of Obstetrics, Gynecology and Reproductive Sciences
203-737-1982 (Office), 203-785-5395 (Appointments)
[email protected]

SOURCE Singlera Genomics Inc.

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