Cutting-edge research has allowed clinicians to get better and better and more personalised than ever in treating an individual's individual cancer, and one area that has been simultaneously exploding is the area of cancer diagnostics. It's not only that modern-day research is coming up with companion diagnostics for specific cancer therapeutics, but more generally, a currently red-hot area is the emergence of the "liquid biopsy".
The liquid biopsy is a non-invasive blood test that detects circulating tumour cells (CTCs) or cell-free tumour DNA (cfDNA) that are separated from the primary site or a metastasised one, which would provide clinicians and patients a much more efficient (as well as less painful and costly) means to monitor the success of an ongoing treatment. The days of lumping everyone into the same boat, for say, chemotherapy, are fading fast, and better stratification of patients such that they can avoid painful, toxic treatments that they won't benefit from is the new norm.
Although the underlying concept is new in today's cancer treatment, the use of circulating DNA for diagnosis purposes is not, and as far back as 1997, it was discovered that a future mother's blood contains DNA fragments shed from the growing foetus inside her; this became the basis of new tests for rapid, early assessment for Down's syndrome with which over one million women have since been screened.
The beauty of liquid biopsy is that unlike a painful tissue biopsy, one can not only get a read on the true heterogeneity of the current tumour population at any given time, but additionally one can follow it in real time to monitor both benefits as well as genotypic changes that may facilitate resistance. Serial biopsies would allow an ongoing analysis of the make-up of a patient's tumour type and subtype, and it's direct response to a chosen course of therapeutic(s).
Given the impact that this will have in cancer centres around the world, it's no surprise (of course!) that that the race to develop the best liquid biopsy is on, and that it is going to be big business. In fact, it is estimated that the market for liquid biopsies will reach an impressive $22B US by 2020, and that number is only going to grow thereafter.
There was a lot of hullabaloo at the recent healthcare summit in Silicon Valley about personalised medicine and diagnostics, and just last night I stumbled upon a "CBS News Investigation" piece, on this very exciting new medical development. Two companies who have already jumped into the liquid biopsy milieu are making (the) most of the news. First up is San Francisco-based Grail, which was created via a massive $100M Series A round that included big names such as Bill Gates and Jeff Bezos, and who with support from former NCI head honcho Richard Klausner are developing a test that in principle could tell a person with no symptoms that they have cancer. The choice of name for the company is no coincidence:
"This has the potential to totally change not just cancer but all of medicine. That's the holy grail!" said Klausner, referring to catching cancer early enough to be able to cure it and not just treat it. Having said that, Klausner is less sanguine than particular rival companies with regards to the when. "The answers are not going to be clear until we do definitive and large scale studies. We just don't have the clinical data yet, and we have to get it."
That is an opinion echoed by many I am sure, not least the FDA, but seems to be less top-of-mind in the other company featured in the story, Pathway Genomics in San Diego. This company is of note for both having heavy hitters with White House connections on their board, as well as making the news via the totally lightweight phenomenon known rather hilariously as "Keeping up with the Kardashians". Quite why any serious scientific, medical or biotech company would choose to use that family as a vehicle for promoting their biomedical value proposition is beyond this writer.
It's probably the result of an equally serious (and seriously ambitious) social media-communications director, who thinks any big audience is worth having. Even, or particularly if, that audience is not a sophisticated nor educated one. As long as the kits sell, right?! But pseudo-frivolity aside, Pathway CEO Jim Plante is not able to just shrug off such commentary, and he faced tough questioning from CBS's Jim Axelrod about claims made on the company's website.
Of note is one of Pathway's newer tests, called CancerIntercept™ Detect, which is available for as little as a few hundred dollars, and which has caused considerable controversy for claiming what critics say is simply not achievable today. In a video posted on their site, Pathway stated:
"CancerIntercept can detect a growing tumor in the body, before the patient may notice symptoms - it's like a cancer stethoscope for detecting and monitoring cancer".
What I find most offensive about such claims is that they are in fact targeted at that totally (well, let's agree to say "totally" in terms of science!) unsophisticated audience that hangs off every word a Kim or Khloe Kardashian says. All it would take is for one of them to praise the company and claim "CancerIntercept saved my life!" to then have a million wannabe-Kardashians (that species known colloquially as Kandashians) screaming their way to the pharmacy to order the test.
However, and of greater concern for Jim Plante, is the fact that a much more sophisticated audience is watching, and the FDA has come out and said that they think Pathway's test might in fact be dangerous and actually harming public health. And in case anyone is in any doubt, it is the FDA who (will) approve such tests, not some candyfloss TV show and their audience. While the audience is keeping up, they are simultaneously being pandered down to, it seems, and that's just not going to be strong, sustainable business for Pathway - period.
"We just watched a video upstairs and it says the liquid biopsy will detect cancer before symptoms," said Axelrod in his interview with Plante.
"It may."
"That's not what the video says."
"It says it may. We don't say-- we don't say will. We say may."
"You don't make the claim that you can detect cancer?"
"We say the information can be used to help guide potential early diagnosis."
Axelrod went on to grill Plante further, but it got kind of painful, and I am sure you get the point. It's one thing to be an ambitious company pushing a hot new product, but when it comes to potentially taking advantage of the weak, the sick and the old, one is treading an extremely fine line. Reputations can go south in a heartbeat, and the FDA can bury such reputations with a swish of their pen. No surprise then, that the video in question on the Pathway Genomics website suddenly disappeared after the CBS News interview.
As Axelrod said to Stanford professor Dr. Max Diehn, it's going to take thousands of patients, several years of testing, and many millions of dollars before claims made by an entity such as Pathway can be substantiated; Max Diehn agreed, and implied that until then the test is effectively meaningless. Not least because physicians themselves have not been educated in the correct interpretation of the outcome of such tests.
In what seems to many as incongruous (or even inconceivable), Pathway is now running three clinical trials to validate their test, but these tests were initiated after the product was already marketed! Such is the scenario for these laboratory-derived tests (LDTs) at the FDA currently, and Pathway took advantage of the lack of regulation involved in marketing these kits, and cranked them out. But everyone knows the clampdown is coming, and so they had no choice but to get into the clinic and get the data that is truly needed, if they are to have a future in this business.
For now, I much prefer the less aggressive non-media-driven approach of Grail, who seem to want to obtain hardcore scientific evidence and solid data to back up their test before or when it hits the market. The fact they are majority-owned by sequencing giant Illumina doesn't hurt, either. They state that they will be in clinical trials by 2017 and hope to have a pan-cancer test ready by 2019, or so, and that seems to be a much more measured and realistic claim.
Here at AmorChem, we have been interested in personalised medicine and better cancer patient stratification/treatment for some time now, and in fact one of our portfolio projects is focused on development of a test for more effective diagnosis and stratification of patients presenting with acute myeloid leukemia (AML). Intense research is ongoing to additionally come up with tests for detection of minimal residual disease (MRD) in that condition, as well as ideally to develop a novel therapeutic(s) for such companion diagnostic tests. For now, we will take the Grail approach, and state that while we are not there yet, we are most definitely getting there!
"This has the potential to totally change not just cancer but all of medicine. That's the holy grail!" said Klausner, referring to catching cancer early enough to be able to cure it and not just treat it. Having said that, Klausner is less sanguine than particular rival companies with regards to the when. "The answers are not going to be clear until we do definitive and large scale studies. We just don't have the clinical data yet, and we have to get it."
That is an opinion echoed by many I am sure, not least the FDA, but seems to be less top-of-mind in the other company featured in the story, Pathway Genomics in San Diego. This company is of note for both having heavy hitters with White House connections on their board, as well as making the news via the totally lightweight phenomenon known rather hilariously as "Keeping up with the Kardashians". Quite why any serious scientific, medical or biotech company would choose to use that family as a vehicle for promoting their biomedical value proposition is beyond this writer.
It's probably the result of an equally serious (and seriously ambitious) social media-communications director, who thinks any big audience is worth having. Even, or particularly if, that audience is not a sophisticated nor educated one. As long as the kits sell, right?! But pseudo-frivolity aside, Pathway CEO Jim Plante is not able to just shrug off such commentary, and he faced tough questioning from CBS's Jim Axelrod about claims made on the company's website.
Of note is one of Pathway's newer tests, called CancerIntercept™ Detect, which is available for as little as a few hundred dollars, and which has caused considerable controversy for claiming what critics say is simply not achievable today. In a video posted on their site, Pathway stated:
"CancerIntercept can detect a growing tumor in the body, before the patient may notice symptoms - it's like a cancer stethoscope for detecting and monitoring cancer".
What I find most offensive about such claims is that they are in fact targeted at that totally (well, let's agree to say "totally" in terms of science!) unsophisticated audience that hangs off every word a Kim or Khloe Kardashian says. All it would take is for one of them to praise the company and claim "CancerIntercept saved my life!" to then have a million wannabe-Kardashians (that species known colloquially as Kandashians) screaming their way to the pharmacy to order the test.
However, and of greater concern for Jim Plante, is the fact that a much more sophisticated audience is watching, and the FDA has come out and said that they think Pathway's test might in fact be dangerous and actually harming public health. And in case anyone is in any doubt, it is the FDA who (will) approve such tests, not some candyfloss TV show and their audience. While the audience is keeping up, they are simultaneously being pandered down to, it seems, and that's just not going to be strong, sustainable business for Pathway - period.
"We just watched a video upstairs and it says the liquid biopsy will detect cancer before symptoms," said Axelrod in his interview with Plante.
"It may."
"That's not what the video says."
"It says it may. We don't say-- we don't say will. We say may."
"You don't make the claim that you can detect cancer?"
"We say the information can be used to help guide potential early diagnosis."
Axelrod went on to grill Plante further, but it got kind of painful, and I am sure you get the point. It's one thing to be an ambitious company pushing a hot new product, but when it comes to potentially taking advantage of the weak, the sick and the old, one is treading an extremely fine line. Reputations can go south in a heartbeat, and the FDA can bury such reputations with a swish of their pen. No surprise then, that the video in question on the Pathway Genomics website suddenly disappeared after the CBS News interview.
As Axelrod said to Stanford professor Dr. Max Diehn, it's going to take thousands of patients, several years of testing, and many millions of dollars before claims made by an entity such as Pathway can be substantiated; Max Diehn agreed, and implied that until then the test is effectively meaningless. Not least because physicians themselves have not been educated in the correct interpretation of the outcome of such tests.
In what seems to many as incongruous (or even inconceivable), Pathway is now running three clinical trials to validate their test, but these tests were initiated after the product was already marketed! Such is the scenario for these laboratory-derived tests (LDTs) at the FDA currently, and Pathway took advantage of the lack of regulation involved in marketing these kits, and cranked them out. But everyone knows the clampdown is coming, and so they had no choice but to get into the clinic and get the data that is truly needed, if they are to have a future in this business.
For now, I much prefer the less aggressive non-media-driven approach of Grail, who seem to want to obtain hardcore scientific evidence and solid data to back up their test before or when it hits the market. The fact they are majority-owned by sequencing giant Illumina doesn't hurt, either. They state that they will be in clinical trials by 2017 and hope to have a pan-cancer test ready by 2019, or so, and that seems to be a much more measured and realistic claim.
Here at AmorChem, we have been interested in personalised medicine and better cancer patient stratification/treatment for some time now, and in fact one of our portfolio projects is focused on development of a test for more effective diagnosis and stratification of patients presenting with acute myeloid leukemia (AML). Intense research is ongoing to additionally come up with tests for detection of minimal residual disease (MRD) in that condition, as well as ideally to develop a novel therapeutic(s) for such companion diagnostic tests. For now, we will take the Grail approach, and state that while we are not there yet, we are most definitely getting there!
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