A recent article published in ProPublica has so much amazing information that we will be outlining today and tomorrow. Part 1 is below. Part 2 will be tomorrow. Happy reading!

In 2020, the American College of Obstetricians and Gynecologists (ACOG) as well as the Society for Maternal-Fetal Medicine stated that every #pregnant woman should have access to #prenatal testing. This testing can be referred to as Non-Invasive Prenatal Testing or Screening #NIPT or #NIPS. Companies such as Natera made over $625.5 million dollars in 2021 on prenatal #genetictesting and #carrier screening. On a recent earnings call, Natera’s Chief Financial Officer stated “The NIPT market is still very under penetrated, compared to the 4 to 5 million pregnancies in the U.S.,” Natera’s chief executive said on a 2021 earnings call, “so there’s a long way to go.” 

This BUSINESS of the LAB industry also creates barriers to ACCURACY EVALUATION.

The lab testing industry has deep pockets to pay for lobbyists that continue to fight to keep bills like the #VALID Act from not moving forward. Despite stories proving inaccurate results or these labs marketing their tests inaccurately to patients and #healthcare providers, the government has done little to improve oversight of Laboratory Developed Tests (#LDTs). #Patient advocates continue to demand change, but this industry continues to be labeled as “The Wild West”. 

Amanda is a patient interviewed in this article that received prenatal testing from Labcorp with a negative result. She underwent a C-section and delivered a baby that lived for only 28 hours. At autopsy, it was revealed that she had an extra 13th chromosome. Amanda, a science researcher, reached out directly to Labcorp after substantial research and learning that others had similar issues with their testing trying to get answers. Ultimately, she was hung up on by a Labcorp employee with no answers.

“If she had taken any number of other common commercial tests — including certain tests for #covid19 or, say, #pregnancy — the company would have been required to inform the FDA about reports of so-called adverse events. But the test Amanda had falls into a regulatory void. No federal agency checks to make sure these prenatal screenings work the way they claim before they’re sold to #healthcare providers. The FDA doesn’t ensure that marketing claims are backed up by #evidence before screenings reach patients. And companies aren’t required to publicly report instances of when the tests get it wrong — sometimes catastrophically.”

“This is a Wild West scenario where everybody is on their own,” said Lawrence Gostin, a Georgetown University law professor specializing in #bioethics.

You don’t have to be on your own!  Demand accuracy as a standard measure for the lab you choose to order or cover for your patients!

The Business of Labs Negatively Impacts the Potential Outcomes for Patients

The lab screening industry continues to expand as it can be lucrative, or at least career sustaining, to deliver these results in an unregulated industry. The FDA acknowledges that there is an issue with accuracy evaluation and outdated policies in place that are driving major #healthcare decisions. 

“Testing companies told ProPublica that, even without the FDA, there is significant oversight. Labs must abide by state regulations, and another federal agency, the Centers for Medicare & Medicaid Services, is charged with monitoring #quality standards. It does not, however, check whether the tests the labs perform are clinically valid.”

These lab companies have also stressed in this interview by ProPublica that it is the responsibility of #healthcare providers to order testing as well as inform patients of limitations associated with screenings.

When it is discussed that there is little to NO data on clinical performance, that is why Center for Genomic Interpretation offers the accuracy evaluations to labs, healthcare facilities and insurance companies.

“As Megan Allyse, a bioethicist at the Mayo Clinic, put it, the companies “launched the test, they started using it on humans, and then they went back and said, ‘Was our test accurate?’” She also questioned the lack of attention to the #ethics of how tests are presented to #patients.”

The business of labs oftentimes doesn’t benefit patients and the PERCEIVED care they are receiving. Money or laboratory employee job security are unfortunately driving many decisions being made – NOT patient care!  It was quoted in this article that those against ACCURACY evaluations stated –
“FDA regulation of LDTs would be contrary to the public health.”

How could a patient receiving accurate results be contrary to public health?  

There is a HUGE problem with healthcare if known accuracy issues are covered up. How can precision medicine be precise if the diagnostic tests driving care aren’t analyzed for accuracy?

This industry will continue to grow and the Center for Genomic Interpretation wants EVERY appropriate patient to have access to ACCURATE genetic or genomic testing results!

Read the full article HERE!