Laura van ‘t Veer, PhD, says it is time for oncologists to speak out and push for a single regulatory standard for high-risk diagnostics. Dr. van ‘t Veer, who is the director of applied genomics at the Comprehensive Cancer Center at the University of California, San Francisco, in San Francisco, CA, says the success of personalized medicine treatment regimens for a growing number of patients with cancer is entirely based on accurately identifying patients with particular genetic mutations before treating them.

The concern is that many molecular diagnostic tests that are being ordered daily by oncologists have not undergone a thorough U.S. Food and Drug Administration (FDA) review and approval process.

“There are hundreds of tests and they are having a major impact on the treatment of patients,” Dr. van ‘t Veer told Cancer Therapy Advisor. “So, this is a bigger issue than it used to be. It has always been an issue, but the issue is becoming bigger because there are more tests.”

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Dr. van ‘t Veer has just published an article calling on the FDA to hold molecular diagnostic tests to the highest regulatory and approval standards.1 Laboratory-developed tests (LDTs) currently are not required to undergo FDA approval before marketing if they are designed, manufactured, and used in a single laboratory. That laboratory simply has to meet the Clinical Laboratory Improvement Amendments (CLIA) certification requirements.2

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How this issue is handled over the coming months will shape the molecular diagnostic industry. Genomics and proteomics are now fueling an explosion of new rapid, sensitive, and less invasive molecular diagnostic tests. Since these tests determine personalized therapies based on genetic mutations, it is vital that regulatory and policy issues are addressed.

On July 31, 2014, the FDA issued a draft oversight framework for LDTs based on risk to patients rather than whether they were made by a conventional manufacturer or a single laboratory.3 The framework includes premarket review for all higher-risk LDTs. The FDA said the framework would be phased in over many years. It plans to issue a draft or final guidance on the regulation of LDTs after it receives more public input over the next several months.

“The world is very divided on this,” said Dr. van ‘t Veer. “The people who are debating this issue are smaller labs who have developed their own testing and will have to comply [with] higher standards than before, and there is confusion about hospitals that are providing their own tests.”

Dr. van ‘t Veer noted that the smaller labs and companies, which are providing the majority of the tests, should be required to undergo more oversight. She said large pharmaceutical companies are in favor of more oversight because it is vital for them to demonstrate the cancer therapies they are manufacturing are being given to the correct patients.

Dr. van ‘t Veer explained that health insurance companies also have a strong vested interest in this issue, noting that precision medicine therapies may cost $50,000 a year or more. “For that reason, you want your test to be specific, safe, and reliable. You have to have the right drug for the right patient. Oncologists need to advocate for this. Oncologists need to be aware of this issue and speak out on it.”

Antonio Wolff, MD, who is a professor of oncology at Johns Hopkins University School of Medicine in Baltimore, MD, said there is a need for FDA oversight. He noted that concerns about accuracy in predictive biomarker testing are an issue that dates back to the 1980s with estrogen-receptor testing and tamoxifen. However, the issue only gained widespread public attention when trastuzumab was approved in 2005 for the adjuvant treatment of HER2-positive breast cancer.