Every year, 50,000 Americans die from colorectal cancer, a common cancer that is easy to detect and can be effectively treated if caught in its earliest stages. Unfortunately, 38 percent of Americans eligible for screening are not being screened. This article explores how one company addressed this need by designing a home sample collection kit that would increase colorectal cancer screening rates.

Design projects are never quite as simple as they first appear, and this one was no different. The basic task — create a simple box that can be sent back and forth through the mail — seems elementary.

The company determined that the exterior graphics must be discreet enough not to betray the contents, yet identifiable enough to know what's inside. (Credit: Exact Sciences)

Yet it's the box itself that drove the challenge. The packaging had to be appealing enough to patients to drive compliance and yet the test still had to be efficacious and provide the level of sensitivity needed to detect the presence of cancer. The designers determined that the box and its plastic contents must be recyclable. Every component must be ergonomically friendly for those people who may have arthritic hands. Exterior graphics must be discreet enough to not betray the contents, yet identifiable enough for people to know what's inside. And the box itself must be 100 percent leak- and odor-proof because it contains a stool sample.

These elements became the primary criteria for designers at Exact Sciences, a Madison, WI-based molecular diagnostics company that developed and commercialized a noninvasive screening test for colorectal cancer.

Creating Cologuard

The box challenge began several years ago when the company was gearing up to market Cologuard®, the first and only stool DNA-based screening test for colorectal cancer approved by the U.S. Food and Drug Administration (see the Sidebar, “About Cologuard.”)

Cologuard was developed in collaboration with researchers at the Mayo Foundation for Medical Education and Research. It went through extensive research and development, including a study of 10,000 average risk participants that demonstrated the test's performance characteristics for colorectal cancer screening.

After being prescribed by a healthcare professional, the Cologuard collection kit is mailed to a person's home in a prepaid, branded white box that also is used to return the completed kit to Exact Sciences for processing. The Cologuard kit is used at home and contains patient instructions, a container, a bracket, a tube with an antimicrobial agent, and a preservative.

The Cologuard kit is used at home and contains patient instructions, a container, a bracket, a tube with an antimicrobial agent, and a preservative. (Credit: Exact Sciences)

The test is designed to identify multiple biomarkers associated with colorectal cancer and high-risk precancer from stool DNA (sDNA). DNA is continuously shed from cells in the intestinal lining, where it is passed into the stool. If cancer or precancer is present, cells associated with the abnormal tissue will shed into the colon, rectum, and stool along with normal cells. Because both precancer and cancer shed abnormal DNA, that DNA can be an early indicator of the presence of colorectal cancer or precancerous lesions before altered DNA would be present in the blood stream.

The company determined that the exterior graphics must be discreet enough not to betray the contents, yet identifiable enough to know what's inside. (Credit: Exact Sciences)

Methylation, mutation, and hemoglobin results are combined in the laboratory analysis to provide a single positive or negative reportable result. The stool sample is prepared and analyzed for fecal occult blood in a qualitative enzyme-linked immunoabsorbent assay (ELISA) that determines the concentration of hemoglobin in the sample.

Following collection, the sample is shipped to the Exact Sciences Laboratories (ESL) where the sample is analyzed. ESL must receive a lab-quality stool sample to provide an accurate test result. Test results are typically delivered to the patient's healthcare provider within two weeks of receipt of the sample by ESL.

Making It Intuitive

Market research showed that people did not want to handle the specimen. Further, the kit had to be intuitive, so that the entire process — from collection to returning the container in the mail — was as simple and clear as possible. Hence, the company developed the Cologuard box, which has been featured in a nationwide television advertising campaign since April 2016. The animated box, “Lil CG”, explains the process, stressing its simplicity by saying, “In fact, I'm as easy as get, go, gone.”

“Because we have this unique specimen, designing the box presented unique challenges from an R&D perspective,” says Mike Domanico, Exact Sciences’ vice president of research and development.

After Collection

While the Cologuard collection kit contains everything a patient needs to collect a sample, the kit comprises just a small fraction of the product's total manufacturing footprint. When the patient sample comes back to the lab, it undergoes thorough testing. The company uses reagent kits, comprising hemoglobin controls, hemoglobin assay reagents, molecular controls, and molecular assay reagents, to test and analyze samples. There are more than 37 assay reagents and controls required to complete testing, all of which are manufactured or tested and kitted by Exact Sciences.

All these pieces add to the complexity of managing supply chain and manufacturing processes. Getting all components right is imperative not only for delivering accurate test results, but also to building and maintaining trust among healthcare providers and patients. Since Cologuard's launch in 2014, Exact Sciences has successfully processed more than one million Cologuard tests while experiencing significant year-over-year growth, and the company has maintained 100 percent product availability (zero back orders).

Improved Screening

What's gratifying for the designers of the test is the fact that more than 90 percent of the samples the company receives have been gathered correctly and can be screened for colorectal cancer. The most common error has to do with the sample being collected but not being sent back in time.

As a result of its exceptional success rate, Cologuard earns high product satisfaction ratings from healthcare professionals and patients. Customer satisfaction surveys conducted by the company revealed that 98 percent of healthcare professionals say Cologuard “met or exceeded” their expectations, and 88 percent of patients rated their Cologuard experience as “very positive.”

But what's most important is that more completed tests means that more people are being screened for a common cancer that is easy to detect and can be efficiently treated if caught in its earliest stages. Nearly half of the people who have used Cologuard have never been screened before, which is a significant step forward in the fight against colorectal cancer.

And the intuitive design of the Cologuard box is certainly contributing to this success. Notably, Cologuard received a Gold Award in the Diagnostic Products and Systems category at the 18th Annual Medical Design Excellence Awards in 2015.

Award-winning simplicity and user-friendly approaches help drive results and overcome the barriers set by 38 percent of Americans eligible for screening and not being screened.

But more importantly than any awards are the lives touched. If potentially one of the 50,000 Americans at risk from colorectal cancer learns about Cologuard, takes the test, and overcomes early stage cancer or precancer, then it is all worthwhile.

This article was written by Leigh Myers, Director, Brand & Patient Marketing, Exact Sciences, Madison, WI. For more information, Click Here .

About Cologuard

Cologuard was approved by FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society's (2014) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. For more information about Cologuard, visit here . Rx only.

The company started with a small kit — based on the assumption that smaller is better — including flushable paper and a plastic cone that fit under a toilet seat to catch the sample. Because colorectal screening is recommended for people aged 50 and above, all components had to be ergonomically friendly and easy to handle.

But in pilot testing of an early prototype, 20 percent of the participants had trouble with the process. “That surprised me,” Domanico says. “We learned as we went along.” Thus followed many subtle iterations of the box that were not apparent to the naked eye as prototypes moved through the design process.

A plastic bracket on the collection container was designed to sit on top of the toilet seat to hold the container, which ensures capture of a complete sample with no need to catch or touch the sample itself. Philips-Medisize Corp., a global outsource design, development, and manufacturing firm, manufactured the container and bracket and was an essential partner throughout the design and manufacture of the product.

Critical to the design was the addition of a floating plate inside the lid of the collection container. A twist latch attached to the plate keeps the container airtight and able to withstand pressure changes during air shipment back to the company and avoiding leakage in transit.

All patient instructions are both pictorial and written for a fifth-grade level. Consumers are walked through the entire process, including how to pour a stabilizing solution into the collection container to preserve the sample. Once complete, all components are securely packed back into the original box, and it is ready for pickup by UPS for shipping back to ESL. A prepaid, preaddressed label is provided to the patient for shipping.