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Exact Sciences launches studies to expand its attack on cancer

December 23, 2018
Innovation One -- as shown in this rendering, at five stories and 138,000 square feet -- will serve as Exact Sciences Corp.’s headquarters in University Research Park. Construction began on the $60 million project in August and is expected to be finished in early 2020.

Exact Sciences Corp. is looking at two new targets for cancer screening: blood cancers and melanoma.

The company also has begun a study to see if its flagship product, the Cologuard stool test for colorectal cancer, is as good at finding the illness in younger people, starting at age 45.

Exact officials have not made any public comment about developing screening tests for blood cancer or melanoma, but the Madison company has registered its plans for the studies, which are listed on ClinicalTrials.gov, a website maintained by the National Institutes of Health. The proposals show that both of those studies were expected to start last month and run through February 2020.

The blood cancer study seeks to draw blood samples from 400 adult patients with “untreated hematologic malignancies” to find biomarkers that show changes in cells or proteins that could signal the presence of cancer.

The proposal doesn’t indicate a specific target. According to the American Society of Hematology, there are three main types of blood cancer: leukemia, which affects blood and bone marrow; lymphoma, involving the lymphatic system; and myeloma, cancer of plasma cells.

The melanoma study plans to look at blood samples from 200 adults diagnosed with the cancer who have not yet had treatment. Melanoma is a less common but often deadly form of cancer that generally attacks the skin but can also be found on other parts of the body, the American Cancer Society says.

Exact spokesman Scott Larrivee said CEO Kevin Conroy would not be available for an interview on the subject, calling it “premature.”

Larrivee said the blood samples “will be used in research and development as we continue working to develop new cancer screening tests.”

Research analyst Brian Weinstein, with William Blair & Co., said the efforts are “consistent with the early stage biomarker discovery programs” Exact has conducted before.

“These are areas they would like to move into, if everything works out, but this is very early stage,” Weinstein said.

It could be years before any of the studies result in new diagnostic products, if at all. Larrivee declined to offer a potential timetable.

“The timeline for medical devices to move from conception and development, to clinical trial, to approval varies,” he said.

Extending reach of Cologuard

More than 1.6 million people have used Cologuard, Exact’s home test kit for colorectal cancer, since the U.S. Food and Drug Administration approved it in 2014. The stool test seeks out DNA and blood biomarkers and is recommended for people ages 50 and up. Meanwhile, the American Cancer Society revised its guidelines last May, suggesting people should be screened for the disease starting at age 45, and Exact is getting a jump on that.

An evaluation of more than 900 people, ages 45 to 49, began in November to see if Cologuard’s stool test can correctly identify colorectal cancer in the younger age group. As a separate sub-study, subjects are being asked to provide a blood sample, too, to find the cancer’s biomarkers in blood, as part of research into future Exact products.

Exact’s Larrivee said the company “is committed to seeking FDA approval to expand Cologuard’s current indication to people age 45 and older who are at an average risk for colorectal cancer.”

Although the FDA has not yet requested the data, getting a head start makes sense, analyst Weinstein said in a research note, “as payers and guideline bodies will likely want to know that false positives do not spike in this age group.”

Expanding the product line

Exact CEO Conroy has said in the past that the company is working on products to look for a host of additional cancers, too.

Conroy first said a blood test for lung cancer would be Exact’s next product but more recently, he pointed to a liver cancer blood test as next in line.

According to the summary on ClinicalTrials.gov, the study to detect hepatocellular carcinoma — a common type of liver cancer — started in April and will continue through July 2019, collecting blood from 1,000 people at risk of the disease, and from 500 patients already diagnosed but not yet treated.

A smaller, earlier study, whose results were reported in June, showed that of 244 people screened in a test developed by Exact Sciences and Mayo Clinic, 95 percent of the cases of hepatocellular carcinoma were detected, with fewer than 1 in 10 false positives.

Also in progress by Exact:

Two large studies of a blood test for lung cancer — one, involving more than 3,000 people, age 35 or older, with lung nodules, confirmed lung cancer or suspected lung cancer; the other, with 1,500 people, age 50 or older, not known to have nodules or lung cancer. Both are scheduled to run well into 2021.Blood samples from 3,000 people with confirmed cases of either breast, lung, colorectal, prostate, bladder, uterine, kidney, pancreatic, liver, stomach, ovarian or esophageal cancer. Results are expected to be used to develop a single blood test that could identify any of those. That study began in August and is expected to wrap up in November 2019.A study of biomarkers for esophageal cancer or Barrett’s Esophagus, a condition linked to chronic heartburn that can result in cancer. The study of 320 patients began in 2015 and is expected to be completed next June.

There is plenty of competition in the race to create blood tests — also called liquid biopsies — for cancer, or for several forms of cancer at one time.

Researchers at Johns Hopkins School of Medicine announced last January the CancerSEEK test they are developing can detect eight types of cancer from one blood test, while a team from Cleveland Clinic and Stanford University said in May, they are working on a test to find as many as 10 forms of cancer.

Weinstein said making sure any such test works effectively and receives cost reimbursement are among the “massive hurdles” that would have to be overcome.

He said, though, if Exact and Mayo are not the first out-of-the-gate with a multi-cancer blood test, it should not rule them out.

“In any industry, a first mover advantage is beneficial, but I think this market will take so long to develop and is so large that anyone who can successfully navigate the major hurdles outlined above will have an opportunity at what is an absolutely enormous liquid biopsy space, be it in screening, monitoring or diagnostics,” Weinstein said.

Exact Sciences has been growing rapidly, and now has about 1,900 employees, including 1,500 in the Madison area, with office buildings and processing labs spread among several locations.

“We’re committed to helping advance the fight against cancer — and not just colon cancer,” Larrivee said.

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