Exact Sciences advancing ‘Cologuard 2.0,’ blood tests for cancer

The Madison-based company is also developing blood tests to screen for colon cancer and for many types of cancer at once. But whether it starts a large, expensive study of its multi-cancer screening test next year could depend on whether Congress tells Medicare to pay for it.

The company — which has about 6,300 employees, 46% of them in Dane County — last month released study results for its “next-generation” Cologuard, for which the company plans to apply for federal approval by the end of the year. Leaders also updated investors on other developments, including a plan by December to market a test for trace remnants of cancer that can remain in blood following surgery and other treatments.

“Our mission is simply to help eradicate cancer with tests that help prevent it, detect it earlier when it’s more treatable and also to guide therapy,” CEO Kevin Conroy said at the company’s annual investor day June 21, according to a transcript of the event.

The biggest news is that the new Cologuard, sometimes called “Cologuard 2.0,” was found to be better than the original in identifying cancer and had a 30% lower false positive rate, meaning fewer people need to get follow-up colonoscopies.

In a study involving 20,000 people, the new test picked up 94% of cancers and was 91% accurate in determining who didn’t have cancer. That’s up from 92% cancer sensitivity and 87% specificity for the original Cologuard in a study of 10,000 people that led to its approval in 2014.

“We’ve got data from a large study, that was twice the size of the original, pivotal trial, that show improved performance,” Dr. Paul Limburg, the company’s chief medical officer for screening, told the Wisconsin State Journal in an interview. “Now, we want to work as hard as we can to bring this next-generation test to the clinic as quickly as possible.”

The new version uses different markers to look for colorectal cancer in stool, Limburg said. It had 43% sensitivity in detecting precancerous polyps, compared with 42% for the original test, and 75% sensitivity in catching the most serious types of polyps, compared with 69% for the initial test.

If the new Cologuard is approved by the Food and Drug Administration, it’s not clear when it might become available. Exact Sciences chief financial officer Jeff Elliott said he expects that to happen by 2027.

More than 12 million tests involving the original Cologuard have been performed, including 3 million last year, with about 60,000 early-stage cancers detected and 385,000 people found to have precancerous polyps, the company said.

A large market remains, with an estimated 60 million Americans ages 45 to 85 unscreened for colon cancer, the company said. The U.S. Preventive Services Task Force two years ago lowered the recommended starting age for screening from 50 to 45. With Cologuard, screening every three years is recommended through age 75, and people ages 76 to 85 should talk to their doctor about getting screened, the task force says.

Exact Sciences is also working on a blood test for colon cancer. The blood test is not anticipated to be as accurate as Cologuard, so it isn’t expected to replace it, Limburg said. But he said a blood test could offer another method of screening for people who can’t or don’t get the currently recommended tests: colonoscopies, Cologuard or other stool tests.

Residual cancer

As Exact Sciences prepares to submit its next-generation Cologuard application to the FDA, the company is getting ready to roll out Oncodetect, a blood test to detect molecular residual disease, or MRD.

Tests for MRD, which is sometimes called minimal residual disease, look for tiny bits of cancer that can remain in the blood after treatment and cause recurrence of tumors. Finding such lingering fragments of cancer before scans can detect it, or confirming they aren’t there, can help guide treatment and reduce anxiety, said Dr. Rick Baehner, the company’s chief medical officer for precision oncology.

The initial version of the company’s MRD test, for colorectal cancer, is expected to be launched late this year, Baehner said. The company is researching another version for breast cancer, with tests for other solid tumors expected later, he said.

After people with stage 2, or relatively early, colon cancer have surgery, the question is whether to use chemotherapy. For stage 3, in which lymph nodes show cancer, the question after surgery is whether to do chemo for three months or six months.

A positive MRD test might lead doctors to opt for chemo or a longer course of it, while a negative test could result in no chemo or a shorter course, with repeat testing continuing to guide treatment, Baehner said.

Last month, Exact Sciences announced an exclusive license agreement with the Broad Institute of the Massachusetts Institute of Technology for a technology that can find more mutations of cancer in smaller bits of blood, Baehner said.

MRD tests “will really personalize and tailor treatment decisions, where today we largely look at how old is the patient or how big is the tumor or what is the grade of the tumor,” he said.

With an estimated 2 million Americans who could benefit from the testing, the company expects MRD tests to be a “multi-billion dollar product,” Elliott said.

Multi-cancer screening

Exact Sciences’ multi-cancer early detection test, or MCED, aims to find more than a dozen types of cancer from one blood draw in people with few or no symptoms.

Most of the cancers — including bladder, esophageal, kidney, liver, ovarian, pancreatic, stomach and blood cancers such as non-Hodgkin’s lymphoma — don’t have recommended screening tests today. Because of that, many such cancers are found late, resulting in expensive treatments with mixed success.

“If we can bring a test that detects those cancers earlier, and in fact provides a screening option, we will be able to … improve lives of patients and result in ultimately lower costs of health care,” said David Harding, the company’s senior vice president for MCED.

In a study involving 15 organ sites or tissue types, the test picked up 61% of cancers and nearly 39% percent of early, or stage 1 and 2, cancers, according to results released in September. Those figures may seem small, but for most of the cancers, essentially no cases are found early today, Harding said.

The company has proposed a large study, involving up to 100,000 people and costing about $100 million, before applying for FDA approval. But it is first trying to persuade Congress to direct Medicare to cover such tests if approved by the FDA. A bill calling for such coverage, introduced in March, has bipartisan support.

“We want to make sure there is some level of support for reimbursement that exists before we dive too deeply into that space,” Harding said.

Exact Sciences now has 6,300 employees, up from about 5,500 two years ago, even though the company in November said it was cutting about 5% of its workforce, or about 350 jobs. The announcement came on top of a reduction of 230 jobs in May 2022.

The company last year attributed the cuts to “inflation, market volatility and prioritization of the programs that will have the greatest impact on improving cancer care.”

In May, Exact Sciences reported a first-quarter loss of $74.2 million, or 42 cents per share, on revenue of $602.5 million, beating analysts’ expectations. The company said it expects full-year revenue of about $2.4 billion.

The company’s stock price on Friday closed at $95.03, up from $47.19 in early January.