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New Publication Shows Consistent Clinical Performance In Screening Common Fetal Trisomies With Harmony Prenatal Test

Roche (SIX: RO, ROG; OTCQX:RHHBY) and Ariosa Diagnostics, Inc., a global leader in non-invasive prenatal testing (NIPT) 1 technology and maker of the Harmony™ Prenatal Test, today announced the results of a new clinical study on the company’s targeted cell-free DNA analysis using microarray quantitation which demonstrated high sensitivity, specificity and extremely low false positive rates for prenatal assessment of Down syndrome and other chromosomal disorders. The consistent assay performance of the Harmony Prenatal Test, published in Prenatal Diagnosis, was attributed to its targeted cell-free DNA analysis method regardless of whether evaluated via microarray or next generation sequencing (NGS).

Ariosa Diagnostics’ Harmony Prenatal Test Now Performed in Australia and United Kingdom at Sonic Healthcare Laboratories

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Ariosa Diagnostics, Inc., a global leader in non-invasive prenatal testing (NIPT) technology and maker of the Harmony™ Prenatal Test, in conjunction with Australian company Sonic Healthcare, today announced that Sonic Healthcare has been granted a license to perform the Harmony Prenatal Test in its Australian and United Kingdom labs. Under the license, Sonic Healthcare will provide the Harmony Prenatal Test and cell-free DNA System, developed at Ariosa’s California laboratory, through Sonic Genetics in Australia and Sonic’s UK counterpart, The Doctors Laboratory (TDL).

Harmony Prenatal Test Now Being Offered in Mexico for Safe and Timely Risk Assessment of Chromosome Conditions During Pregnancy

Ariosa Diagnostics announced the offering of its Harmony™ Prenatal Test in Mexico through a partnership with Advance Medical on August 22, making the Latin American nation with over 2 million live births one of 46 countries around the world where the Harmony Prenatal Test can be ordered by healthcare providers. The Harmony test enables clinicians throughout Mexico to offer a non-invasive, early, reliable blood test to pregnant women. The Harmony test is both safe and cost effective, providing a personalized risk assessment for chromosome conditions such as Down syndrome.

The Harmony test has an accuracy rate above 99% for evaluation of fetal trisomy 21 risk, and a false positive rate of 0.1%, which is 50 times lower than conventional serum screening, translating into fewer referrals to unnecessary invasive diagnostic procedures such as amniocentesis that carry the inherent risk of miscarriage.

According to Dr. Dora Gilda Mayen Molina, Medical Genetic Specialist at the Hospital Angeles Lomas and Hospital Angeles Mexico, “The Harmony Prenatal Test can be performed for women with pregnancies of at least 10 weeks gestational age, and it is available for any singleton or twin pregnancy, including all those conceived by IVF.”

A recent study published in the American Journal of Obstetrics and Gynecology provided new evidence that non-invasive prenatal testing, specifically the Harmony test, is effective for screening in the general population. In the study of more than 2,000 women undergoing routine screening for fetal trisomies, the Harmony Prenatal Test accurately assessed the risk of all cases of fetal trisomy 21 and 18, with a false positive rate of 0.1 percent.

According to Dr. Thomas Musci, vice president of clinical and medical affairs for Ariosa Diagnostics, this partnership will “allow us to bring the highest quality and most clinically validated prenatal test to patients in Mexico for the betterment of prenatal medicine. We are very pleased to have partnered with Advance Medical.”

Source: PR Newswire

Ariosa Diagnostics, CHU de Quebec and Genome Canada to Launch Large-Scale Cost-Effectiveness Study of Non-Invasive Prenatal Testing in Canada

A team of researchers led by CHU de Quebec and Universite Laval, have received CAN$10.5 million from Genome Canada, the Canadian Institutes of Health Research (CIHR), Genome Quebec and other partners to conduct a large-scale comparative effectiveness study on non-invasive prenatal screening techniques. Dr. Francois Rousseau and his team will examine current prenatal screening practices for chromosomal conditions, such as Down syndrome, among pregnant women in Canada in order to improve screening approaches and avoid unnecessary procedures.

Each year in Canada, about 450,000 women become pregnant and are offered Down syndrome prenatal screening using biochemical and ultrasound markers. The vast majority will be negative or low risk. However, for positive or high-risk results, those pregnant women are referred to amniocentesis, which is an invasive procedure done to confirm the screening result. Approximately 5% of all biochemical screening results are falsely positive, attributing to unnecessary invasive procedures that pose a 1 in 300 risk for miscarriage.

Genome Quebec is a strong supporter of public-private partnerships, such as the one developed between Ariosa Diagnostics and Dr. Francois Rousseau’s team. The PEGASUS: PErsonalized Genomics for prenatal Aneuploidy Screening USing maternal blood project, made possible through such partnerships in personalized medicine, will help meet women’s healthcare needs by giving them access to safer prenatal screening tests, explains Marc LePage, Genome Quebec’s President and CEO.

The research project aims at independently comparing the performances of different such approaches that involve various combinations of the available tools for screening of chromosomal conditions, as well as to evaluate the cost-effectiveness, the ethical and social aspects of this new technology and to identify and adapt the best implementation tools for users in the health care system. The researchers will recruit 5600 pregnant women (3600 at high-risk of trisomy conditions and 2000 at low-risk). Samples from these women will be tested in parallel using different screening approaches that involve genomic-based NIPT, but also existing or new biochemical and ultrasound screening tools. The samples will be analyzed without knowledge of the true status of the pregnancy outcome. This will provide a comprehensive evaluation of the most efficient ways to improve the prenatal screening techniques widely used today.

Ariosa Diagnostics is one of the major commercial partners for this project and will provide testing for part of this large sample that will include mainly low-risk women. The investigators have chosen the Harmony™ Prenatal Test as the commercially available NIPT assay to be included as one the various screening tests that will be compared.

Dr. Rousseau, Leader of the Project, mentions: “We are happy that Ariosa Diagnostics has joined this effort and provided a significant contribution to this Project. Ariosa’s Harmony test is the most affordable commercial NIPT available, and it was chosen by the research team for this study because it is the most likely to be used in the Canadian context.”

Dr. Thomas Musci, VP of Clinical and Medical Affairs at Ariosa remarked that: “Ariosa, as a core corporate value, is committed to furthering rigorous clinical and scientific study of cell-free DNA technology and the Harmony Prenatal Test in a variety of clinical settings and in a number of different countries. We are extremely pleased to support this collaboration with Genome Canada and fully support the goals of their research efforts.”

Dr. Serge Rivest, Director of the research Centre at the CHU de Qudbec, stated that: “The leadership of the researchers from CHU de Quebec Research Center was key in putting this exceptional academic team together to tackle one of the hottest clinical application of next-generation sequencing in the context of a population-based screening program.”

Source: Ariosa Diagnostics