There’s a major flaw in the FDA’s definition of a companion diagnostic, one that Thermo Fisher Scientific is working to overcome.
According to the FDA, “A companion diagnostic is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product.”
The issue here is that the language is singular. One diagnostic for one product or drug. For patients with non-small cell lung cancer (NSCLC), a lot of genes need to be screened, results are needed fast, and there isn’t a lot of tumor sample to go around. A series of one-off diagnostics aren’t fit for the job.
Thermo Fisher’s Oncomine Universal Dx test for NSCLC aims to replace sequential testing with a single, NGS-based assay. The company announced today that it had filed the final module of a premarket approval (PMA) application for the panel, which screens 47 genes and has the potential to add more.
Joydeep Goswami, Thermo Fisher’s president of clinical next generation sequencing, said the panel is extremely well-suited to tackling the challenges of NSCLC.
“Lung cancer has multiple different genes that are involved, so you need the stratification in terms of treatment based on very specific molecular signatures of the disease,” Goswami said in a phone interview.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In the United States, lung cancer is the leading cause of cancer-related deaths and its impact extends throughout the world. A number of therapies have been approved or are in development to treat specific mutations. However, determining the optimal treatment for each patient is complicated by the difficult process of acquiring tumor samples, along with the time it takes to generate results.
“As you can imagine, it’s quite hard to get the lung biopsy. They don’t have a lot of material, given the nature of the disease,” Goswami said in a phone interview. “You don’t want to use up all of the sample and have to go in for more. It’s very expensive, but more importantly, it’s very hard on sick patients.”
Current tests take at least 10 days to return results, Goswami explained. During that time the patient may get no treatment or the wrong treatment. When a number of tests are required, it can take several weeks or even months to determine the best course of action.
Goswami said the Oncomine panel takes five days to run, from sample preparation to end result. While other diagnostic tests require 40-100 nanograms of DNA input, Thermo Fisher’s platform requires less than 10 — and sometimes as low as one — nanogram of DNA.
To test for multiple therapeutics on a single panel, Thermo Fisher has formed partnerships throughout the industry. Deals with Pfizer and Novartis have already been announced and Goswami said more are in the works.
“We have ongoing partnerships and projects with multiple companies that are now going to prove their drugs, or attach their drugs to other genes on this panel, or maybe the same genes,” Goswami said, adding that clinical trials with other therapeutics companies were already underway.
Along with matching patients with the appropriate treatment, Thermo Fisher also pitches the panel as a tool to help develop and validate new NSCLC drugs.
With a lot of industry support and talk of a ‘paradigm shift,’ the panel sounds very progressive. Oddly enough, though, it may not be the most advanced technology available today, even within Thermo Fisher.
Liquid biopsy techniques fully bypass the need for invasive tissue sampling. All going well, they could eventually make traditional biopsy procedures obsolete.
The core idea came through the revelation that dying cancer cells release fragments of tumor DNA into the blood, which move throughout the patient’s bloodstream. With a simple blood draw, that circulating tumor DNA (ctDNA) can be isolated and sequenced to reveal actionable genetic mutations.
“Can liquid biopsy do the same thing? The answer is, we think so,” Goswami said. “But it’s a new technology that has to be proven in accordance with the traditional biopsy approach.”
Early trials indicate liquid biopsy methods may be capable of much more than matching traditional tumor analyses. The technology paves the way for earlier screening and ongoing monitoring of disease progression.
Despite the looming disruptive potential of liquid biopsies, Goswami said the Oncomine panel is still a fundamental and proven advance. And with so much riding on the diagnoses, the industry is in no rush to experiment.
“I don’t think this is a stopgap or a bridge, this is the gold standard for today.”
Photo: blueringmedia, Getty Images
