![]() “It needs to get back on track to really helping the pregnant population and their families.Go to form What is the Harmony Test (NIPT) ? “This program is a mistake and it needs to be changed urgently,” Platt said. ![]() He pointed to language in the regulation that said physicians’ licenses could be jeopardized if they did not follow the new rules. ![]() “Our patients have been very upset,” Lawrence Platt, a UCLA clinical professor of obstetrics and gynecology, said at the hearing. 26, more than a month after the state mandated the new rules, officials held a meeting at which doctors, genetic counselors, patients and lab executives complained about the changes. Some doctors recommend the screenings only for women considered to be at higher risk of birth defects, including those age 35 or older. If a screening comes back positive, the agency said, other tests are required to show the fetus actually has the abnormality. The agency said it was aware of reports that patients had decided to terminate pregnancies based on the screenings even though they are meant only to show whether there is a higher risk that the fetus could have a certain birth defect. In April, the FDA warned that the tests could give false results, including “reporting a genetic abnormality when the fetus does not actually have one.” The prenatal tests are not regulated by the Food and Drug Administration and the agency has not tried to confirm how accurate they are. Lost in the promotion of those tests and the push by companies and the state to offer them is data showing the results can be wrong. The companies offer prenatal screenings for the three rare disorders as well as dozens of other possible but uncommon birth defects. The state has appealed the judge’s preliminary injunction, officials said.įor lab companies, the prenatal tests have become a profitable and fast-growing business. They said they had been meeting with physicians and others involved in the testing since 2019. State officials also questioned claims by doctors and labs that the department had not consulted them before changing the rules. 15, 98% of results were reported to the patient’s physician within 14 days. According to the department’s data, they said, from Oct. Officials disputed reports that large numbers of results had been delayed. In a written statement, officials said they made the changes to ensure “high quality, affordable, up-to-date prenatal screening available to every pregnant Californian.”Īs part of the changes, they said, the state switched from an older method of prenatal screening to a newer technology called cell-free DNA screening, which is more accurate. State public health officials declined to speak to The Times. Californians would not be able to choose the prenatal screening of their choice, the complaint said, “without the prying eyes of the state.” In their lawsuit, Labcorp and Myriad argued that the program violated women’s right to privacy since they would have to use the state program and the contracted labs if they wanted the three common prenatal screening tests. State officials told doctors that the results would be recorded in a government database, and in turn delivered more quickly to patients. The move prompted Labcorp and Myriad Genetics, two corporate labs that had been selling the tests but were banned from offering the three in the state program under the new rules, to bring a suit against the state’s public health department on Sept. Natera, Quest Diagnostics, PerkinElmer and Kaiser were awarded contracts to perform the three noninvasive prenatal tests, or NIPTs, covered by the state program. 19, without holding the public hearing that is usually required to change regulations, the state limited the program so that just four companies could process the tests that look for genetic disorders such as Down syndrome. The reported delays came after California health officials changed regulations governing the state’s prenatal testing program. In online pregnancy discussion groups, dozens of California women have detailed their long waits for results and the anxiety it has caused as they wonder whether their children could have one of the rare disorders. “It has been extremely frustrating and caused a lot of stress,” said Manriquez, who lives in Anaheim. More than a month later, 26-year-old Manriquez is still anxiously awaiting her results from California’s state-run prenatal screening program. 1, Kate Manriquez, whose first child is due in May, did what many women do a couple months into their pregnancies: She gave a blood sample at her doctor’s office for a genetic test meant to help detect birth defects.
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