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Bioptická Laborator s.r.o.. (5/10/17). "Press Release: Bioptická Laborator Now Offering Panorama NIPT in Czech Republic via Natera's Constellation Cloud-based Software Platform". Pilsen.

Region Region Czech Republic
Organisations Organisation Bioptická Laborator s.r.o.
  Organisation 2 Natera Inc. (Nasdaq: NTRA)
Products Product Panorama™ prenatal genetic screeening test
  Product 2 Constellation™ s/w platform
Index term Index term Bioptická (CZ)–Natera: Panorama prenatal test, 201707– license to Constellation technology to offer Panorama NIPT in Czech Republic
Persons Person Putzová, Martina (Bioptická Laborator sro 201705 Molecular Geneticist)
  Person 2 Markov, Marin (Natera 201705 VP International Sales)
     


Natera (NTRA), a leader in non-invasive genetic testing and the analysis of circulating cell-free DNA, and Biopticka Laborator, one of the largest and most well-established laboratories in the Czech Republic, today announced a Constellation™ technology transfer licensing agreement that enables Biopticka Laborator to leverage Natera’s proprietary single nucleotide polymorphism-based (SNP) technology to screen for fetal aneuploidies.

Constellation allows laboratories worldwide to access key technologies that Natera uses in its own lab, enabling them to develop, validate, and clinically offer complex, next-generation clinical genomics testing from their own facilities. The licensing agreement also includes access to Natera’s proprietary reagents, algorithms within the constellation softwarer platform and scientific collobration to develop procedures based on best practices from Natera’s laboratory.

Biopticka selected Natera’s SNP technology because of its sensitivity, specificity, and ability to deliver lower false positive rates and false negative rates for aneuploidies when compared to other non-invasive prenatal screening technologies. The SNP platform accurately measures and reports fetal fraction for every sample and it is one of few platforms that incorporates fetal fraction into sample analysis. The targeted sequencing approach of the assay also has economic benefits, by focusing expensive sequencing reads on specific genetic regions of interest rather than randomly across the whole genome. This enables Biopticka to achieve higher resolution and clinical performance with a lower overall sequencing cost than other approaches.

“A deciding factor in wanting access to Natera’s technology was the quality of the Panorama test, which highly leads the other NIPT tests in all the important parameters. The quality of the test is obvious from positive predictive values in "high-risk" but mainly "low-risk" populations, where the difference between Panorama and other NIPT tests is huge. Further, zero fetal sex errors in validation studies and the highest sensitivity among all NIPTs for 22q deletion were attractive features. We also appreciate all the control mechanisms applicable during the laboratory and bioinformatic workflow.” said RNDr. Putzova Martina, Ph.D., the molecular geneticist at Biopticka laborator in charge of the test selection and technology transfer, who has experience in prenatal and noninvasive testing.

"We are very pleased that Biopticka Laborator has chosen to license our unique SNP technology," said Marin Markov, VP of International Sales at Natera. "Our SNP technology platform has been a key differentiator for Panorama.”


About PanoramaTM

Panorama is a safe and simple way for expectant mothers to gain information about the health of their fetus without an invasive diagnostic procedure. Panorama uses a simple blood draw from the mother to examine cell-free DNA found in maternal blood originating from both mother and fetus to screen for chromosome abnormalities, including trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome), monosomy X (Turner syndrome), triploidy, and five microdeletions, the most common of which is the 22q syndrome. The screening test can be performed as early as nine weeks into gestation and there is no risk to the fetus.


About ConstellationTM

The Constellation software platform provides cloud-based access to the bioinformatic algorithms that Natera has developed for clinical genomic applications in circulating cell-free DNA. The availability of these algorithms allows laboratory licensees to rapidly develop and validate their own clinical genomic assays for current applications such as NIPT and non-invasive prenatal paternity testing and future products in development such as liquid biopsy assays for oncology. The Constellation software platform is developed to meet rigorous patient privacy standards and is highly scalable to accommodate the growing demand for genetic testing around the world.


About Biopticka

Bioptická laborator s.r.o. is a leading provider of genomics solutions for personalized healthcare, with its state-of-the-art next-generation sequencing lab in Pilsen. Biopticka is the largest cytology laboratory and the largest biopsy laboratory in the Czech Republic. The laboratory employs 260 workers, including 50 doctors and university staff. It offers examinations of gynecological cytology (oncological and functional examination of smears from the cervix, vaginal, vulvar, and endometrial mucosa) and non-gynecological cytology, biopsy, and complete biopsy service with a direct connection to any necessary immunohistochemical and molecular genetic testing for all surgical, dermatological, gastroenterological, ENT, gynecologic practices and hospitals.

In 2016, the laboratory examined 150,000 patients for biopsy, and 800,000 patients for cytology. It has contracts with all health insurance companies in the country. It has a large genetics department, which is specialized in diagnostic of oncology issues. It is accredited by CIA (Czech Institute for Accreditation) under CSN EN ISO 15189 and holds accreditation of Ministry of Health for cervical cancer screening. For more information, visit www.biopticka.cz


Contact:

Bioptická laborator s.r.o.
RNDr. Martina Putzová, Ph.D., + 420 604 473 856 , putzova@biopticka.cz


   
Record changed: 2017-08-04

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