By Bob Marshall, Chief Editor, Med Device Online
March is National Colorectal Cancer Awareness Month. The Colorectal Cancer Alliance is holding Undy Runwalks across the country in March, and throughout 2018, to increase awareness and raise funds to help knock colon cancer out of the top three cancer killers.
Approximately 4.6 percent of men (1 in 22) and 4.2 percent of women (1 in 24) will be diagnosed with colorectal cancer (CRC) in their lifetime, according to a report from the American Cancer Society. CRC mortality rates for older men and women have been decreasing since 1980. As of 2004, the rates have been decreasing more rapidly, a decline thought to predominantly reflect the detection and removal of precancerous polyps as a result of increased CRC screening. So, get off your butt, and go get tested!
When I became a quinquagenarian a few years ago, my primary care physician encouraged me to get a routine screening colonoscopy. She even wrote me a prescription and gave me a list of recommended local GI doctors. Like some of you out there, I procrastinated for a bit. Why do we do that? Per the American Cancer Society report referenced above, “Despite the large body of evidence supporting the effectiveness of CRC screening and the availability of a variety of test options, screening utilization for CRC remains lower than for breast and cervical cancers. Screening-related challenges include no usual source of care, inadequate insurance coverage, lack of provider recommendation, logistical factors (e.g., transportation, scheduling, and language), fear, and lack of knowledge.”
My own hesitation could only be attributed to one thing – fear. I was apprehensive about the procedure, and maybe a little uncomfortable thinking about the endoscope in my “end.” In retrospect, the fear was unfounded, and could anything possibly be more taboo than Charmin’s Shiny Hiney Song?
From Taboo To Tattoo
A company taking the next step in the fight against colon cancer is GI Supply, headquartered in Camp Hill, PA. The company was founded nearly 30 years ago by Dr. Frank Jackson, a gastroenterologist and entrepreneur, to help solve the many clinical challenges he faced in daily practice.
GI Supply recently introduced the Spot Ex Endoscopic Tattoo, its next-generation marking device for tattooing of malignant lesions, post-polypectomy sites, and difficult-to-detect polyps, to enable identification at follow-up colonoscopies or during future surgery. Spot Ex is 50 percent darker than the current product, making the tattoo easier to find, and it provides a permanent mark — enabling a lifetime of patient care follow-up. Unlike the Paramount Network’s long-running reality series — where tattoo artists are put through extreme challenges to prove their skill, and win a cash prize, plus the title of “Ink Master” — GI Supply’s simple endoscopic tattoo could help you win by saving your life.
I spoke with Patrick Lee, VP of research & development, and Scott Moeller, VP of quality and regulatory, to learn more about Spot Ex and GI Supply.
“We all come from pretty robust backgrounds, having worked with larger life science companies, but we are now with a small, Pennsylvania-based company. We are here for a reason. We are driving to make a difference. When I joined last year, the Spot Ex program had been through about two years of feasibility work. We came together quickly as a team and made decisions together about what the product would do and how we were going to do it. We then brought the discipline and understanding of how to do it from our larger company backgrounds, but keeping it lean and agile,” Lee said. “As a previous colleague of mine once said to me, 'I always will take the shortest path, but no shortcuts.' That’s what we’re all about. I think, sometimes, larger companies are inefficient because they get too much unnecessary process built into product development, and don’t operate on the true shortest path.”
Differences In Global Regulations Create Complexity
Moeller explained that the regulatory landscape for Spot Ex differs greatly across the globe.
“In some countries, they view this no differently than a dermatological tattoo. It’s just applied endoscopically instead of on the dermis, so they regulate it as a cosmetic. In the U.S., the pathway was straightforward, but Europe has taken longer,” Moeller said. “Over in Europe, the regulations around this product are extremely intense. We have been working for 15 months to get Spot Ex on the market, because it is viewed as a long-term implant. Usually, the U.S. pathway for a product is the most onerous. But, in this case, the FDA is recognizing the product is low-risk, with a long history of safe use, to provide a more reasonable pathway.”
It’s Not Just Business, It’s Personal
Lee shared a personal story explaining his purpose and perspective.
“My father is a doctor, and he’s probably his own worst patient. He found out he had cancer, but no one even knew about it, not even his own wife – my mom. He was just silent, alone, and so stressed out about it, especially as the cancer had grown too large to be surgically removed. He didn’t have anyone to talk to; he didn’t even know there is a whole community of people, let alone his own family to support him,” Lee said.
“We’re out there trying to fight cancer, share the latest ways you can get treated, and the statistics on survival rates. However, it wasn’t until about six months into his treatment, after unsuccessfully battling it with low-level radiation, did he open up to us because he would need to undergo high-dose radiation. It was then I realized we had never talked openly about cancer,” Lee continued. “I wondered, if I had been showing my support, would he have opened up earlier, instead of being silent and alone trying to fight this disease? For me, it was very personally eye-opening about how much more we need to be proactively talking about cancer and the methods for early detection, even in younger people in the 20s and 30s. If you have a family history or any of the symptoms, go get checked.”