FDA Wants to Shut Down the Loophole that Theranos Used But Some Politicians Don't Get Why

November 18, 2015
By Alex Keown, BioSpace.com Breaking News Staff

WASHINGTON – The U.S. Food and Drug Administration (FDA) is looking to shore up loopholes that allow companies, including embattled Theranos, to market certain diagnostics tests without having to go through the regulatory process, theverge reported late Tuesday.

During a Tuesday hearing of the Energy and Commerce's Subcommittee on Health in the U.S House of Representatives, lawmakers discussed lab developed tests, a category that allows diagnostic companies “that develop and conduct a diagnostic test in a single lab the ability to avoid submitting their tests to the FDA before using them on patients,” theverge said. The category was created to allow hospitals the room to modify commercially available tests in order to suit the needs of patients. However, that loophole has allowed some companies such as Theranos to market diagnostics tests without having to “demonstrate the tests' validity to the FDA first.”

The FDA has been seeking to shore up these loopholes since at least 2014, according to government documents. On Tuesday Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, told lawmakers the regulatory agency wants to make sure the lab developed tests “are accurate, reliable and that they do, in fact, identify a disease," theverge reported. Shuren added that if the testing is inaccurate, then physicians can make the wrong diagnosis and jeopardize the health and safety of patients.

In a Monday report, the FDA said lab developed tests have “become significantly more complex and higher risk, with several notable examples of inaccurate tests placing patients at otherwise avoidable risk.” In its report, the FDA cited 20 lab developed tests that bolster the need for oversight. Some of the tests cited include OvaSure, the ovarian cancer screening test, a Pertussis (whooping cough) test, both of which the regulatory agency said could yield false positives. Some tests the FDA cited may produce false-negatives, which would mean patients are not seeking treatment they need. Some of those tests include the Oncotype DX HER2 breast cancer test and the HPV test using the SurePath Collection Medium. Other tests the FDA cited could yield both false positives and false negatives.

Some lawmakers were not convinced by the FDA’s arguments, saying their offices were not being “flooded with calls” about unregulated tests, theverge reported.

The FDA did not include Theranos’ testing in its report, however the California-based startup has had its share of troubles with the FDA. After an inspection of Theranos’ facilities, the FDA Administration called the company’s proprietary Nanotainer tubes an uncleared medical device in inspection reports released in October. Although the FDA’s documents are heavily redacted, federal regulators were critical of some of the practices its inspectors observed, including improper classification for its proprietary Nanotainer tubes used for blood specimens. The FDA said Theranos’ Nanotainer blood specimen tubes are not properly filed as a Class II medical device, but are instead being identified as a Class I medical exempt device. As a result, the FDA said Theranos is “currently shipping this uncleared medical device in interstate commerce between California, Arizona and Pennsylvania.”

Theranos has been under fire over its finger-prick blood tests, which the company says could be used to perform a variety of medical tests and be conducted cheaper and faster. A Wall Street Journal report alleged the company only performs 10 percent of its blood tests on its proprietary technology and opts to perform the majority of its blood tests using technology acquired from other companies, including Siemens . In the article, the Journal cited several former Theranos employees, as well as the medical records of patients who had used the Theranos blood test. According to the article, the former employees allege the company split testing between its own proprietary Edison machines and technology acquired from other companies. The use of the two separate technologies yielded different results “when testing for vitamin D, two thyroid hormones and prostate cancer.”

Theranos dismissed the allegations, saying they were “grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents.” Theranos said the report also failed to take into account recent developments made in the company’s Edison technology.

In July, the FDA approved Theranos’ systems and test for herpes simplex 1 virus. The FDA clearance includes the use of Theranos’ Nanotainer Tubes for tests run by this method, which allow samples to be collected from just a few drops of blood from a virtually painless prick of a patient’s finger.