Theral's Picks: The FDA Moves (Again) to Regulate LDTs
Theral's Picks: The FDA Moves (Again) to Regulate LDTs
In another about-face, the FDA announced this past Friday that it would regulate LDTs.
Those of us with some history in the field of diagnostics are saying, “Here we go again.”
The last round during the Obama administration (towards the end, I might add—why not at the beginning?) had all of the interested parties putting on their best arguments for and against or somewhere in between. As soon as we had all weighed in with our brilliance, Trump was elected.
Here’s one of our most recent interviews on the topic from 2016 just before the election with John Longshore, Director of Molecular Pathology at the Carolinas Healthcare System, now Head of Scientific Affairs for Global Oncology Diagnostics at AstraZeneca.
Lab directors, CEOs, and physicians must be all asking the same thing today. Is this a decision that will shortly be reversed?
Arguments against regulation include:
a) This is a dynamic, new, and quickly changing field. Early regulation will hamper an area of medicine that is still figuring itself out. There is a danger in defining the rules before we know what the game is.
b) Many LDTs are created for narrow situations. For labs to go through the regulatory process might make the tests redundant. Think of the early days of the pandemic.
c) Regulation is expensive. Many labs would have to give up serving patients with a test because they can’t afford the resources necessary to see it through the regulatory process.
d) Many of these tests are direct-to-consumer and consumers deserve the right to their genomic information without a paternalistic government interfering.
Arguments for:
a). Testing, such as genetic testing, is part of the field of medicine and should therefore be regulated. Harm can be done to patients. From Friday's press release: "The FDA is concerned patients could initiate unnecessary treatment, or delay or forego proper treatment altogether, based on inaccurate test results, which could result in harm, including worsening illness or death.”
b) Yes, point taken about a developing field, such as whole genome sequencing tests. But how do we know what the game is unless we define the rules? As the FDA says in the press release, regulation could benefit innovation. If you look at the history of drug development, the FDA has a reputation for being the gold standard worldwide. FDA approval can mean good business because there is buy-in from physicians, patients, scientists, and the government.
c) Regulation can be done in stages and based on the risk level of the test in a way that is good for patients and businesses.
d) Direct-to-consumer tests can impact the patient just as a test administered in a hospital.
Regulation and oversight should not be politically partisan. Famously, the EPA was created during the Nixon administration. There is bipartisan legislation before Congress called the VALID Act introduced in the House of Representatives by Congressman Larry Bucshon (R-Ind.) and Congresswoman Diana DeGette (D-Colo.). The VALID Act proposes to modernize regulatory oversight of in-vitro clinical tests (IVCTs) – including in vitro diagnostics (IVDs) and laboratory-developed tests (LDTs). Perhaps the process is too slow for those in the Biden administration, but the legislation has been created and modified with input from stakeholders on all sides.
We’ve invited Dr. Jeff Shuren from the FDA to the program to talk about this recent change in policy and what it can mean for the industry and for patients. And we will find someone to represent the laboratories that for years have pushed back on the topic. This decision might mean more if it came out just after the upcoming election. In any case, the FDA must listen to all stakeholders and proceed in a measured way that will not discourage an area of medicine with such terrific promise.
Friend of the program and diagnostics consultant, Bruce Quinn, weighed in on his blog, Discoveries in Health Policy, here.
We’re out recently with an interview of a company that may end up in the history books. Called SonALAsense, the company is treating cancer with sound.
Chief Medical Officer Ely Benaim explains how the new therapy works. First of all, treatment with sound is accompanied by an intravenous formulation of aminolevulinic acid (ALA) which stimulates the body to make heme. (The most common heme is hemoglobin.) Cancer cells need much more ALA than normal cells to function and grow, says Ely. Cells also need iron to convert ALA into heme. When cancer cells are given more ALA but without iron, they become a potential “smart bomb” which is then activated by ultrasound.
Similarly, therapy using blue light has been approved for years for skin cancers. But light cannot pass through the body like sound and this therapy is therefore not efficacious for internal cancers. In addition, ultrasound as a technology has been widely developed—there is nothing to invent here.
Trials are ongoing.
With the announcement of the Nobel Prize this week for Medicine and Physiology going to biochemist Katalin Karikó and immunologist Drew Weissman for discoveries that enabled the development of mRNA COVID vaccines, we’ve been re-reading a terrific article by Gina Kolata that came out in the New York Times during the pandemic.
She grew up in Hungary, daughter of a butcher. She decided she wanted to be a scientist, although she had never met one. She moved to the United States in her 20s, but for decades never found a permanent position, instead clinging to the fringes of academia.
Now Katalin Kariko, 66, known to colleagues as Kati, has emerged as one of the heroes of Covid-19 vaccine development. Her work, with her close collaborator, Dr. Drew Weissman of the University of Pennsylvania, laid the foundation for the stunningly successful vaccines made by Pfizer-BioNTech and Moderna.
On Monday, they were jointly awarded the Nobel Prize for Physiology or Medicine for their research.
For her entire career, Dr. Kariko has focused on messenger RNA, or mRNA — the genetic script that carries DNA instructions to each cell’s protein-making machinery. She was convinced mRNA could be used to instruct cells to make their own medicines, including vaccines.
But for many years her career at the University of Pennsylvania was fragile. She migrated from lab to lab, relying on one senior scientist after another to take her in. She never made more than $60,000 a year.
By all accounts intense and single-minded, Dr. Kariko lives for “the bench” — the spot in the lab where she works. She cares little for fame. “The bench is there, the science is good,” she shrugged in a recent interview. “Who cares?”
Read the whole thing.