Corning and Exact Sciences Partner to Help Advance Noninvasive Colorectal Cancer Screening | Custom 100 mL Pipet | Corning

Custom 100 mL pipet from Corning enables Exact Sciences to move forward with large-scale release of Cologuard® and advance colon cancer screening.

Exact Sciences of Madison, Wisconsin is on a mission to eradicate colorectal cancer. In August 2014, the company received FDA approval for the first test of its kind, Cologuard, a noninvasive stool DNA-based colorectal cancer screening test that requires no prior bowel preparation or dietary restrictions. FDA approval followed a largescale clinical trial, involving 10,000 patients, in which Cologuard found 92% of curable stage cancers, as well as 69% of high-risk pre-cancers — those most likely to develop into cancer.1

Potential to Greatly Increase Screening Compliance

A screening test able to detect colon cancer at its earliest stage is critically important; most people understand that early detection saves lives. Yet many put off getting a screening colonoscopy despite knowing its importance. So what’s the best way to help people overcome their natural resistance? Simple, make screening easy. And that, says Cara Tucker, Senior Manager, Marketing Communications, Exact Sciences, is one of the major advantages of Cologuard, which is used in the privacy of the patient’s own home.

Enter Corning Life Sciences

But there was a major obstacle standing in the way of Exact Sciences’ ability to take the test from clinical trials into physician practices across the country and around the world. That’s where Corning Life Sciences came in. Working in close collaboration with the Research and Development team at Exact Sciences, Corning enabled the company to resolve a pesky problem in the sample collection transfer step that could have slowed down its ability to commercialize Cologuard.

A Mixed Bag of Goods

The partnership story began in 2013, just as the clinical trial was wrapping up and just as Justin Krause joined Exact Sciences. The first day on the job as its Nontechnical Manager of Clinical Laboratory Operations, Justin recalls walking into the lab where stool samples were being prepared for testing. “I immediately realized we had a big problem on our hands,” he says. As he explains, clinical trial participants were asked to collect the stool samples at home, then mail the kit back to Exact Sciences lab for analysis, where the samples were first homogenized to help ensure uniform consistency. “We tried using a standard pipet to transfer the samples for analysis, but it didn’t have a wide enough mouth to accommodate the range of specimens,” says Justin.

As Justin emphasizes, “Without Corning’s willingness to work with us to come up with a viable solution, we wouldn’t be where we are today.”

Nail Clipper Workaround, Far From “Ideal”

Researchers at Exact Sciences came up with a temporary fix, using a sterile dog nail clipper to cut and widen the pipet tip. But the pipet would frequently lose suction. Multiple draws were often necessary to extract a sample for transfer, and the sample amount drawn was often finite. “Using a dog clipper in a lab environment to modify a standard pipet was far from ideal. It was extremely timeconsuming; you couldn’t always get a clean clip. There was a lot of waste, added costs, and it could have opened us up to safety and contamination concerns,” explains Justin.

No Standard Off-the-Shelf Solution

The Exact Sciences Research and Development team reached out to several manufacturers to see if an off-theshelf pipet existed that would resolve its liquid handing challenges. They found nothing in the market that would work for the spectrum of stool specimen thicknesses. Through the grapevine, the team heard that Corning Life Sciences has a knack for solving difficult production issues by partnering with customers to design custom products. As Justin emphasizes, “Without Corning’s willingness to work with us to come up with a viable solution, we wouldn’t be where we are today.”

Not Too Narrow, Not Too Wide — “Just Right”

It took about six months — and multiple iterations — to develop a pipet that was “just right — not too narrow, not too wide,” Justin recalls. “We got to be Goldie Locks in the story. We’d say, there’s not enough pressure to pick up volume, and Corning would go back at it again.” And Justin notes, “At the time, we were just a small lab in Madison with a big dream. We weren’t nearly as well known and hadn’t yet gotten FDA approval.” In fact, as Justin points out, “Every time we place a new order, Corning has to shut down its production line, then rework it to accommodate us. That speaks volumes about them; they care enough about supporting their customers, they were willing to get into the trenches with the little guy from Wisconsin before we had even secured FDA approval.”

Corning Sets Exact Sciences Up For High Throughput Screening

Once the prototype was finalized, Corning delivered its first batch of 40,000 custom 100 mL pipets in the Fall of 2014, helping Exact Sciences establish a highly-automated, state-of-the-art clinical laboratory to streamline the sample transfer process and increase its high throughput capabilities. Says Justin: “Corning set us up so that we could commercialize and scale up using a lean and clean process.”

Accelerating Adoption

Today, Cologuard is being adopted by such major healthcare providers as Mayo Clinic Health System, along with more than 10,000 independent physicians. As of June 2015, Exact Sciences had already screened a large number of samples and expects that number to continue to quickly accelerate over the coming months.

Ready to Deliver To Meet Demands

Corning stands ready to deliver the volume of pipets required to keep pace with demand. As Karen Gan, Business Director, Liquid Handing, Corning Life Sciences, says: “Corning is exceptionally honored to be part of Exact Sciences’ mission to eradicate colorectal cancer. We have no doubt that Cologuard will transform colon cancer screening, as more and more people hear about the technology and begin routinely asking their doctors about Cologuard. When it comes to cancer screening, it’s all about advancing early detection, and that’s what Cologuard is all about.”


  1. Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 370:1287-1297(2014).