Common

Questions

Common

Questions

Common

Questions

Common

Questions


How are the Constellation™ algorithms currently being used?

Natera’s CLIA lab currently uses the Constellation algorithms for genomics testing, including copy number counting (CNC) to perform non invasive prenatal testing (NIPT).

What are the risks to patient privacy for results analyzed using Constellation™?

Constellation™ does not collect protected health information. The input data for Constellation are short fragment raw sequencing reads from the next generation sequencing (NGS) analysis and contain no patient identifying information.

How does a lab utilize Constellation™?

The Constellation™ software service can be used by obtaining a license to the algorithms.  Natera assists in integration of the software with your LIMS. Typical integration validation times vary based upon customization and laboratory capabilities.

What customer support does Natera offer to laboratories that use Constellation™?

Natera provides system integration assistance, Constellation software platform training, and ongoing customer support.

How much does the Panorama NIPT cost?

Based on previously processed claims data, the majority of patients have an out of pocket expense between $100 and $200 once their deductible has been met.

The cost of Panorama varies according to the prenatal screening panel selected and your specific insurance coverage. Natera is pleased to be in-network with most national insurance providers, including Aetna, Anthem, Cigna and UnitedHealthcare.

Our team is available to determine eligibility for financial assistance, or set up a payment plan to meet your needs, please call 877-869-3052.

What is Constellation?

The Constellation™ software platform allows clinical labs access to Natera’s proprietary algorithms for genomics screening.

What algorithms are available using Constellation™ platform?

Currently, non invasive prenatal paternity (NIPP) and tools for evaluating genomic copy number counting (CNC) are offered on the Constellation™ platform. Natera plans to add future tests, including liquid biopsy for oncology applications.

What technology is needed to use Constellation™? Is special equipment required?

The Constellation™ software platform analyzes data obtained from next generation sequencing (NGS). Laboratories must have access to a high throughput DNA sequencer for Next Generation Sequencing (NGS). Constellation™ requires internet bandwidth of [4MB/sec] to transfer the NGS data for analysis. Analyzed results can be integrated with an existing Laboratory Information Management System (LIMS).


How are the Constellation™ algorithms currently being used?

Natera’s CLIA lab uses the same reagents and algorithms being offered to partners. The Constellation™ platform has been validated at the Natera facility and is currently used for Natera’s in-house laboratory testing on NIPT, NIPP and CNV samples. Several Natera Constellation™ partners are currently using the platform to offer NIPT.

What are the risks to patient privacy for results analyzed using Constellation™?

Constellation™ does not collect Protected Health Information (PHI). The input data for Constellation are short fragment raw sequencing reads from the next generation sequencing (NGS) analysis and contain no patient identifying information.

What type of regulatory accreditation does Constellation™ have?

Natera is ISO 13485:2003 certified and maintains a quality management system which is in compliance with the EC In Vitro Diagnostic Medical Device Directive (98/79/EC). Reagent kits and software components made available to Constellation™ partner labs have been registered with the Competent Authorities. Natera has a CE Mark for Panorama-specific NIPT reagents and Constellation software.

How does a lab utilize Constellation™?

The Constellation™ software service can be used by obtaining a license to the algorithms. Natera assists in integration of the software with your LIMS, and provides the protocols and reagents for developing assays of interest, plus technical and laboratory training and support.

Typical integration validation times vary based upon customization and laboratory capabilities.

What customer support does Natera offer to laboratories that use Constellation™?

Natera offers Constellation™ partner laboratories a dedicated applications team to assist in assay development, testing verification and system integration.

What is Constellation?

The Constellation™ software platform provides clinical laboratories the opportunity to develop, validate and offer Natera’s genomics tests.

What tests are available on Constellation™?

Currently, Panorama® noninvasive prenatal testing (NIPT), noninvasive prenatal paternity (NIPP) and tools for evaluating genomic copy number variants (CNV) and microdeletions are offered on the Constellation™ platform. Natera expects that additional products will be added to the Constellation platforms in the future.

What technology is needed to use Constellation™ NIPT? Is special equipment required?

The assay is performed using standard molecular biology laboratory equipment and resources and requires a high throughput DNA sequencer for Next Generation Sequencing (NGS). Access to Constellation™ requires internet bandwidth of [4MB/sec] to transfer the (NGS) data for analysis by the proprietary Natera algorithms. Analyzed results can be integrated with an existing Laboratory Information Management System (LIMS).

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