Phillips-Medisize, a Molex company, has announced the successful collaboration with Exact Sciences, a cancer diagnostics specialist, to advance early cancer detection. 

Fuelled by a pursuit for smarter, earlier life-changing answers about cancer, Exact Sciences developed Cologuard, an FDA-approved non-invasive stool DNA screening test for colorectal cancer. This mission aligned with Phillips-Medisize’s record of innovation and product design, development and manufacturing capabilities.

Paul Chaffin, president, medical and pharmaceutical solutions, said: “We offered Exact Sciences a one-stop shop of advanced manufacturing. From human factors design, complex moulding, and reagent handling to volume manufacturing, finished packaging, as well as labelling and serialisation, we have everything they needed to bring this innovative product to market. We brought a powerful mix of capabilities and expertise to help Exact Sciences change the game in the fight against colorectal cancer.”

According to the American Cancer Society, colorectal cancer is the second most common cause of death in women and men combined in the U.S., resulting in about 53,000 fatalities in 2021. When detected early, about 90% of stage I or stage II cases are treatable, yet one in three adults over age 50 are late on recommended colorectal cancer screening. Concurrently, new cases of colorectal cancer are increasing among young and middle-aged adults, which prompted the United States Preventive Services Task Force (USPSTF) to recommend screenings starting at age 45.

Thanks to teamwork between Exact Sciences and Phillips-Medisize, Cologuard is aiming to help transform how Americans think about colorectal cancer screening. Together, the companies ensured product performance met usability and quality requirements.

Tammy Turek-Etienne, VP of Operations at Exact Sciences “Our focus and mission is really on the patient experience. Everything we do is around quality and that end-user, so we can ensure they have a really great experience with the products.”

Using at-home testing, the collective group embraced human factors design principles to prove patients of all ages and abilities could effectively open and close the different components within the collection kit. Phillips-Medisize developed new tooling to safeguard against inadvertent leaks while meeting specifications and tolerances required to produce the highest levels of product quality.

Supply chain flexibility enabled Exact Sciences to acquire all the parts, products and raw materials needed to rapidly scale kit production. Phillips-Medisize located and validated alternate supply sources, conducted risk assessments and forecasting, as well as sourcing and procurement plans to protect against unplanned disruptions. The organisation’s ability to increase safety stock, hold spare parts and leverage its buying power helped Exact Sciences attain supplies and raw materials to meet increasing demand, such as resin.

During the pandemic, colorectal cancer screening rates plummeted as large swathes of the population postponed annual doctor’s visits and regular screenings. Resources were redeployed and production schedules were readjusted to accommodate volume changes and avoid overstocking.

In supporting sustained growth while mitigating risk, Phillips-Medisize diversified its manufacturing footprint by transitioning a former Molex manufacturing site in Little Rock, Arkansas, to complement its medical manufacturing sites in Wisconsin.

Phillips-Medisize now operates three production lines at U.S.-based manufacturing facilities in Wisconsin and Arkansas where a combination of manual, semi-manual and highly automated manufacturing is used to produce 40,000 screening test kits each week. As a result, more than six million Americans have used Cologuard for screening and early cancer detection.