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Exact Sciences Ramps Up Plans for Pipeline Development as Cologuard Market Share Grows

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NEW YORK (GenomeWeb) – Exact Sciences — whose Cologuard colorectal cancer diagnostic test has been steadily gaining market share — is focusing on expanding the test's label to a new patient group, creating a new and improved version of the diagnostic, and developing new liquid biopsy tests for other types of cancer.

The company reported after the close of the market on Tuesday that its first quarter revenues rose 79 percent, thanks to a corresponding 79 percent increase in testing volumes. Nearly 14,000 healthcare providers ordered their first Cologuard test during Q1, and more than 160,000 clinicians have ordered the test since it was launched, Exact said. This brings Cologuard's estimated market share to 4.6 percent, up from the 4 percent market share the company reported at the end of 2018.

The firm has always said that its long-term goal is to reach 40 percent market share, and the momentum Cologuard has exhibited gives company executives confidence that they'll reach their goal. But the firm is taking steps to ensure Cologuard's growth and has also begun to further the development of other diagnostics in its pipeline.

The company reported that it has applied to the US Food and Drug Administration to expand Cologuard's label so it can be used for people in the 45-to-49 age group who are at average risk for colorectal cancer. As of now, the test is approved for people who are between the ages of 50 and 85 and are at average risk.

On a conference call with analysts after the release of its earnings, Exact CFO Jeff Elliott said the company estimates that there are 87 million average-risk Americans between the ages of 15 and 85. In 2030, that number is expected to grow to 97 million, and 20 million of them will be between 45 years and 49 years old. If the label for Cologuard is successfully expanded, that will create a total available market of 117 million people for the diagnostic, he noted, adding, "That equates to a $20 billion US opportunity, and our goal is to capture at least 40 percent."

As Exact Chairman and CEO Kevin Conroy noted in a presentation at the JP Morgan Healthcare Conference in January, expanding Cologuard's label would immediately increase the market opportunity for the test by 19 million people or a potential $4 billion.

"Expanding Cologuard's FDA label … is an important opportunity. More than 10 percent of the total years of life lost to colorectal cancer are due to a diagnosis between ages 45 and 49," Conroy further said on the earnings call. "Since 1994, the incidence of colorectal cancer increased more than 50 percent in people younger than 55. We believe Cologuard could help solve this problem."

He also noted that the American Cancer Society updated its colorectal cancer screening guidelines in May 2018 to recommend that people at average risk start regular screening at age 45, either with "a sensitive test that looks for signs of cancer in a person's stool (a stool-based test), or with an exam that looks at the colon and rectum (a visual exam)."

Since the update, Conroy said, several large insurance providers have lowered their coverage screening age to 45, including Anthem for federal employees, Aetna, and CareFirst.

The firm is also working to make improvements to Cologuard. During the fourth quarter earnings call, Conroy said Exact's researchers worked with investigators at the Mayo Clinic and found promising biomarkers that could improve Cologuard's performance, especially its specificity. He called the program Cologuard 2.0, and said the firm was working to validate the markers.

On Tuesday's call, Conroy said the initial data from the new markers is encouraging in terms of both sensitivity and specificity, and that these markers have the potential to improve "the overall health economic case for Cologuard," adding, "We will provide updates as we validate these markers and work with the FDA on an approval pathway."

Conroy further noted that the primary goal with Cologuard 2.0 is to maintain the same level of sensitivity for detecting cancer, and then to improve the specificity and therefore lower the false-positive rate.

"We had a head-to-head comparison [of the Cologuard 2.0 markers in stool] with the current Cologuard test, and we're really pleased. That gives us confidence to continue moving forward with the program and to sit down with the FDA, and then thereafter begin a prospective study," Conroy said.

The company is also prioritizing the expansion of its pipeline — specifically, its blood-based cancer diagnostics program. Through Exact's long-term collaboration with the Mayo Clinic, it has discovered biomarkers associated with 15 cancers, and it is in the process of performing validation studies for these markers, Conroy said.

Exact plans to share several new pieces of early data at the Digestive Disease Week conference in San Diego later this month, he added.

"One of the liquid biopsy tests we're working on in collaboration with the Mayo Clinic is for liver cancer, a disease that kills 30,000 Americans and 600,000 people worldwide each year. There are more than three million people who should be tested regularly in the US, and our goal is to provide a better option than the current standard of care, ultrasound, either with or without the alpha fetoprotein test," Conroy said. "Early-stage cancer sensitivity for ultrasound alone is estimated to be 45 percent, and combined with AFP, it is still less than 65 percent sensitive. Patients failed to comply with recommended testing more than two-thirds of the time. A more accurate and convenient test may … encourage more people to get tested," he added.

Exact is currently enrolling patients in a large case control study to further validate and finalize development of the liver cancer test, he noted. The company has also begun evaluating potential sites to open a new lab for its future pipeline products.

Conroy also noted that the company will likely present data at Digestive Disease Week on a study Exact conducted in collaboration with the Mayo Clinic for pancreatic cancer detection from blood.