SEC complaint filed against Natera for promoting prenatal screening technology

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FIRST ON FOX: A tech watchdog has filed a complaint with the Securities and Exchange Commission (SEC), alleging that biotech firm Natera misled the public about its prenatal screening technology.

Presented Friday, complaint comes about two weeks after the New York Times published an article about the accuracy of non-invasive prenatal testing (NIPT) from companies like Natera. That report, according to the Campaign for Accountability (CfA), pointed to data that would have told a different story than Natera’s marketing, SEC filings, and public statements.

Natera told FOX Business that the CfA allegations were false: “The entire premise of this story and every allegation in it stems from opportunistic and baseless legal maneuverings by corporate plaintiffs trying to foment litigation. … If any of these alleged claims are ever brought, we look forward to vigorously defending ourselves and exposing these claims for what they are through the appropriate legal channels.”

The CfA complaint points to earnings calls in which founder Matthew Rabinowitz compared the artificial intelligence for his test, known as Panorama, to the supercomputer that beat chess champion Garry Kasparov. This and other so-called “outlandish claims” by Natera “are, quite simply, untrue”, according to CfA. Another aspect of the complaint is that Chief Operating Officer (COO) Robert Allan Schueren sold approximately 10,800 shares in the weeks preceding the Times article.

Blood sample for NIPT or non-invasive prenatal test, diagnosis of fetal Down syndrome in pregnancy. (iStock/iStock)

CfA also referenced a graph from The Times which it said was later changed. This graph claimed that a Natera study suggested a high number of false positives for its NIPT for DiGeorge syndrome, which is associated with intellectual disability and heart defects.

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“In a recent study, Natera said its latest algorithm would identify roughly the same number of false positives,” writes the Times. “But that same study also included results from when the tests were done. These numbers suggest there would be three times as many false positives as there were real cases.”

The CfA file focuses on that of Panorama patient flyerwebsite, and SEC filings — arguing that they omit or don’t provide enough information about the company’s false positives.

pregnancy

A woman receiving an ultrasound. (Stock)

“By dishonestly touting the accuracy of its NIPT to investors, Natera may be directly or indirectly, in the offer or sale of securities, through the use of means or instruments of transportation or communication in interstate commerce or through the use of couriers, obtaining money or property by means of false statements of material facts, or by omitting to state a material fact necessary for the statements made in light of the circumstances in which they were made, are not misleading,” the CfA filing alleges.

Natera’s filings have provided general statements about uncertainty, and its most recent 8-K discusses the prevalence of certain microdeletions in the population.

He also says his tests are more than 99% accurate. His SMART study, which Rabinowitz cited during his call for results, “reported clinical outcomes for 22q11.2 (22q) deletion syndrome in 18,014 patients, and we provided a correct outcome in 17,982 of those patients (99.8%)”.

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“Our results are even stronger with our new Panorama AI algorithm. Additionally, we were able to successfully detect 75% of 22q deletions in the study and 83% of cases with our improved algorithm.”

The NIPT controversy has sparked intense debate because the method can change the expectations of pregnant women and potentially influence the decision to abort the fetus. Fox News Digital reported last week that several GOP politicians have called for some form of accountability after the Times analysis found an 85% false positive rate for the five most common microdeletion tests from several businesses. The Times article was also quoted by many law companies announcing investigations into Natera.

Pregnant mother touching and looking at her pregnant belly at home. (Stock)

When studying NIPT, researchers also look at “positive predictive value” (PPV), which refers to the likelihood that the result will be a true positive and that the disease will actually be present in the population.

Dr. Tara Sander Lee, a researcher at the Charlotte Lozier Anti-Abortion Institute, told FOX Business that while NIPTs are much better than standard screens, they continue to face issues with false positives in women with low blood pressure. risk. For example, a 2014 study found a PPV of 45.5% in screening for Down syndrome in low-risk women. This PPV, she said, means “the probability of a woman being a true positive is less than 50%. More than half of the results will be false and [the] disease will not be present.”

In a press release earlier this monthNatera said her microdeletion PPVs ranged from about 5% to 50% and compared her PPVs to historical prenatal screening norms.

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“While a false positive result can be difficult information for future families to receive, these PPVs compare favorably to historically accepted maternal serum-based prenatal screening methods, which have been used routinely for approximately 80% of all pregnancies over the past 40 years and are still recommended by ACOG [the American College of Obstetricians Gynecologists] today,” the company said.

“In fact, historically accepted prenatal screening tests have PPVs of approximately 3-5% (1/33-1/20) for chromosomal conditions. In contrast, Natera’s microdeletion test has PPVs ranging from approximately 5% to 50%, depending on the specific microdeletion syndrome being screened for.”

Screenings aren’t necessarily the end of the road for expectant mothers looking to learn more about their unborn children.

In agreement with ACOGNatera says she recommends diagnostic testing and genetic counseling.

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“We require a licensed physician to order tests, and we do not perform testing unless a physician signs the requisition indicating that the patient has consented to testing,” the company said in its press release. hurry.

“Additionally, we put the PPV for each condition directly on the patient report with a recommendation for confirmatory diagnostic testing, so doctors can discuss the results with their patients.”

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