Colorectal cancer is among the most preventable cancers, with greater than 90% survival rates when detected early. Yet it is the second leading cancer killer in the United States.
In this interview we speak with Atul Sharan, President & CEO of CellMax Life a leading cancer diagnostics company whose mission is to transform how cancer is diagnosed and managed with globally affordable non-invasive tests for early cancer detection and management.
Please tell us the story of founding CellMax Life. What sparked the idea and how has it evolved so far?
There were a few aspects that came together, one being that as we age, if you are lucky, there is one degree of separation between cancer and yourself, which may sound naïve in these times with infectious diseases and the current pandemic we face with Covid but infectious diseases tend to come and go where Cancer remains. My mother passed away of esophageal cancer, which was unfortunately detected quite late and more recently my wife underwent a mammogram. The good thing about breast cancer is there is a lot of awareness and lobby but the mammogram is not really the greatest test for screening especially with women who have dense tissue. In my wife’s case her mammogram was negative but there was something there that concerned me. At that stage I was already at a venture capital firm looking at early detection of cancer and against her physician’s advice I pushed her to get more imaging done, two weeks later following the conclusively negative mammogram she was diagnosed with early breast cancer.
In cancer there has been a lot of advances on treatment but in reality, there is only one cure which is to be found early before it spreads, and that the surgeon can resect the tumor. The other problem is that cancer does not generally show symptoms, only when it is very late associated symptoms display. The idea was for a blood test that could detect cancer early and ultimately be affordable enough to be globally adopted. There is a lot of attention paid to developed countries, but cancer is a global problem.
I was resident at Artiman Ventures, a Silicon-Valley venture capital firm in the US, where we were looking at solving a big problem, so it was really a confluence of events. My co-founder, Professor Ying-Chang who was a researcher at Stanford, had earlier moved to Taiwan, so we ended up starting the company with a lab in Taiwan and a lab here in the US.
What makes CellMax Life unique to other diagnostics companies?
Nothing is conclusive in cancer without a tissue biopsy, many tests and imaging can be done but ultimately before it can be actionable you have to do a tissue biopsy, the exception being colon cancer. As next-generation sequencing has become more prevalent, people are able to detect smaller amounts of signals of tumor DNA cheaper which led to looking at liquid biopsy.
What is unique here for us is a little different. Once a tumor forms it starts shedding cells into your blood stream and neighboring areas. These cells are abnormal cells that your immune system will try to kill off if your blood stream, as they survive they shed DNA, tumor DNA so a lot of the source of the tumor DNA is from the cells that are shed from the tumor. Some tumor DNA may be shed directly into the blood stream but really it is the cells, called circulating tumor cells or abnormal circulating epithelial cells which if found early in the blood, can have a great signal but there is no platform that can find these.
What we do is look for these very rare cells, as well as tumor DNA. Other companies primarily only look for circulating tumor DNA (ctDNA) as there is a readily available platform with Illumina next-generation sequencing that enable ctDNA. But for finding these elusive one-in-a-billion cells we had to develop our own end-to-end proprietary platform and technology to query blood. The platform is bio-mimetic and multi-disciplinary. We manufacture our own patented microfluidic chip and proprietary anti-bodies and related materials that we use to coat the chips with. In short, the key difference between us and others pursuing early cancer detection is that we can detect these cells through our proprietary platform and combine that with tumor DNA.
How does your testing work?
From a patient standpoint it is simply a regular blood draw, we then divide it up into two – one that we run through our propriety system to find the cells, the other we run through Illumina next-generation sequencing to look for the mutations.
We initially focused primarily on colon cancer, the reason here which is also unique about us is colon cancer goes through a pre-cancer stage called polyps, clinically known as adenomas. Colonoscopy’s look for these polyps or adenomas and because we can detect these cells very early on, we are uniquely able to detect adenomas which nobody else is able to do, detecting colon cancer at a pre-cancer stage.
Is your testing accessible to anyone or are you required to work through a health practitioner?
Our goal is to make testing accessible to everyone. We market some related tests through our lab in Taiwan in self-pay countries in Asia where it is more direct to consumer but in the US, direct to consumer for screening tests is very challenging, ultimately the general physician prescribes the screening tests. Our plan in the US is to go for FD approval and then work with the general physician.
How accurate are blood tests versus more traditional screenings such as Colonoscopies for Colorectal cancer?
Traditional methodology screening is all very different for example breast cancer you have mammograms, colon cancer you have colonoscopy’s, for lung cancer you can have a low-dose CT scan, for prostate you can do PSA but for some there is no traditional screening. The idea really is for the blood test to be better than existing non-invasive screening tests. The colonoscopy was never meant to be used as screening, it was meant to remove polyps and tumors. The reason the colonoscopy is used for screening is because today there is no non-invasive test, which is stool tests, that can detect the polyps where a colonoscopy can, which is also very expensive to perform.
Our test will basically mimic the colonoscopy, but it’s not intended to, and can never replace it because you still need it to remove the adenoma or the tumor. Traditional screening in colon cancer is stool tests but this has two problems. Firstly they cannot detect pre-cancer and secondly, they always suffer from compliance as nobody wants to do a stool test.
Do you think that DNA testing and analysis should be standardized into our healthcare systems?
I think it has gone both ways, in the desire to commercially generate revenue, in my opinion, there are a lot of unnecessary DNA testing that is being pushed. In the US alone there are well over 50, 000 direct to consumer DNA tests which nobody really knows what they do. Once you have satisfied the 2% intellectually curious worried-wealthy, when you take that report to your physician, they may not be familiar with the reporting or meaning. Like any field, I think it will go through some sort of hype cycle and eventually settle into a proper use of testing analysis where it is actually useful and consolidate into something meaningful over time. The advances are what is allowing us to tackle COVID compared to several years ago.
How do you envision the future of the industry or expect to see more of in the coming years?
I think it is an exciting time as blood tests for cancer screening are coming but you have to be careful because firstly most of the US heavily funded companies who are chasing cancer screening are going to rely on large amount of reimbursement meaning it is not going to be a solution for the rest of the world, secondly the promise is ahead of the reality right now in terms of there is a lot of excitement but there is no actual product that is standard of care but I think they are coming and as the costs go down over several years people will look at the problem globally and not just in the US. In the US one third of the GDP is healthcare so there is a lot of money spent which other countries cannot afford.
