Natera enhances Panorama prenatal test with deep sequencing technology

Natera Inc. (NASDAQ: NTRA) announced an enhancement to its Panorama non-invasive prenatal test using SNP-informed deep sequencing technology. The enhancement reduces the no-call rate to 0.5% and improves performance in samples with low fetal fraction, according to the company.

Fetal fraction refers to the proportion of placental DNA in a pregnant patient's blood sample. Low fetal fraction can make it more difficult to detect chromosomal abnormalities during prenatal screening. Patients with low fetal fraction face increased risk of aneuploidy.

The enhanced test is supported by a prospective, blinded clinical validation study of 3,323 pregnant patients, including 242 samples with low fetal fraction. All samples had outcomes confirmed by diagnostic genetic testing. The study demonstrated 100% sensitivity for trisomy 21, 93.3% sensitivity for trisomy 18, and 100% sensitivity for trisomy 13 in patients at low levels of fetal fraction.

"Low fetal fraction has remained one of the most important challenges in non-invasive prenatal screening," said Sheetal Parmar, senior vice president of medical affairs for women's health at Natera. "Panorama now combines the power of our proprietary SNP-based approach with a novel deep sequencing technology that maintains strong clinical performance even in low fetal fraction samples."

The company cited prior literature indicating challenges with sensitivity at low fetal fractions, with one study showing 62% sensitivity for trisomy 21 at low fetal fraction. Most counting-based non-invasive prenatal tests provide results at low fetal fraction without providing specific clinical performance data for these populations, according to Natera.

The information is based on a company press release statement.

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