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June 08, 2022

Natera Granted New PLA Code by American Medical Association for Limited Version of NIPT

AUSTIN, Texas, June 2022 — Natera, Inc. (NASDAQ: NTRA) announced today that the American Medical Association (AMA) has approved a new Proprietary Laboratory Analysis (PLA) code that covers the company’s Vasistera noninvasive prenatal test (NIPT), which screens for a limited set of conditions. A PLA code is a unique form of CPT® code granted by the AMA enabling labs to more specifically identify a test. The new PLA code, 0327U, is available to be used immediately, and takes precedence over CPT code 81420 for the Vasistera test.

Vasistera is a limited version of NIPT for those physicians seeking to screen a pregnancy for only trisomy 21, trisomy 18, and trisomy 13, with optional fetal sex reporting. Given the more limited approach, Vasistera incorporates analysis of fewer sequencing reads and SNPs than Natera’s flagship NIPT, Panorama.

Natera plans to expand the availability of Vasistera by offering it through California’s Prenatal Screening Program (PNS). California expects to offer limited NIPT for all pregnancies in the state starting in September, allowing screening for trisomy 21, trisomy 18, and trisomy 13, with optional fetal sex reporting. Natera was one of a small number of labs selected by the California Department of Public Health to provide NIPT services through the PNS. Natera anticipates the state will use this new PLA code to bill payers for the Vasistera tests ordered in the program, in accordance with AMA guidance.

Reference

  1. Definitive Healthcare report to identify billing for NIPT based on US Clearinghouse for Medical Claims using CPT codes 81420, 81507, 81422.