Natera has announced the termination of a distribution agreement with Bioreference Laboratories.
With the ending of the distribution agreement, Natera intends to promote Panorama directly to clinicians, who previously ordered this test through Bio-Reference.
Natera also plans to promote its Horizon carrier screen test to these clinicians, which it had not done previously.
"Panorama and Horizon are trusted names in prenatal testing, and with our strong U.S. sales force we are able to reach most of the OBGYNs and MFMs, allowing us to create greater value. These physicians will now have access to Horizon, which is a highly differentiated carrier screening test," said Matthew Rabinowitz, Ph.D., CEO of Natera.
"Over the last three years, we have increasingly focused our commercial efforts on our direct channel in the United States.
“While we continue to enjoy highly productive commercial relationships with regional laboratory partners and hospital systems, transitioning from large national laboratory partners to our direct channel significantly reduces channel conflict and has been a very successful approach for Natera."
Natera is a genetic testing company that develops and commercializes non-invasive methods for analyzing DNA. The mission of the company is to transform the diagnosis and management of genetic disease.
In pursuit of that mission, Natera operates a CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, CA, and it currently offers a host of proprietary genetic testing services primarily to OB/GYN physicians and fertility centers, as well as to genetic laboratories through its cloud-based Constellation™ software system.
Tests include the Spectrum® pre-implantation genetic test for embryo selection during IVF; the Anora® miscarriage test to understand the genetic causes of a pregnancy loss; the Horizon™ carrier test to detect inherited mutations; and the Panorama® non-invasive prenatal test (NIPT) to identify common chromosomal anomalies in a fetus as early as nine weeks of gestation.
Each test described has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test. These tests have not been cleared or approved by the U.S. Food and Drug Administration (FDA).
Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.