Exact Sciences’ new push, a blood test for many types of cancer at once, will become available to some patients this summer, as the Wisconsin company seeks Medicare coverage authority before launching a major study intended for federal approval.
Meanwhile, a competitor received federal approval last week for a stool-based colon cancer screening test to rival Exact Sciences’ similar Cologuard. The Food and Drug Administration approval of ColoSense, by St. Louis-based Geneoscopy, comes after Exact Sciences sued Geneoscopy in November over alleged patent infringement and in January applied for FDA approval of Cologuard Plus, an upgraded version of its test.
Exact Sciences’ new multi-cancer blood test, Cancerguard, looks for protein and DNA fragments shed by a variety of cancers, including many types with no recommended screening tests today. It is expected to be “much more impactful” than Cologuard, CEO Kevin Conroy said earlier this year.
Starting this summer, patients at Baylor Scott and White Health in Dallas and another center will be able to get the test in what’s known as a “real-world evidence gathering study,” said Dr. Tomasz Beer, chief medical officer for multi-cancer early detection at Exact Sciences. The company declined to name the second center.
It will be the first time the test will be given to patients outside of a traditional clinical trial.
Exact Sciences has proposed a large clinical trial, involving up to 100,000 people and costing about $100 million, before applying for FDA approval. But the company is first trying to persuade Congress to authorize Medicare to cover such tests if approved by the FDA. A bill calling for such coverage, introduced last year, has bipartisan support.
A competitor, Grail, launched a similar test, Galleri, three years ago, as a “lab-based” test allowed in certain settings without FDA approval. Some 20 such cancer tests are under development, a report said last year.
Recommended screening tests are available today for just four types of cancer: mammograms for breast cancer, Pap smears for cervical cancer, colonoscopies or stool tests for colorectal cancer and CT scans for people at high risk for lung cancer.
No routine screening tests exist for about two-thirds of cancer diagnoses and deaths, Beer said. Patients typically are diagnosed after developing symptoms, which can delay treatment and reduce survival, he said.
Multi-cancer early detection tests like Cancerguard aim to find traces of a range of cancers, especially those not covered by existing tests, including bladder, esophageal, kidney, liver, ovarian, pancreatic and stomach cancers, and blood cancers such as non-Hodgkin’s lymphoma.
“We’re looking at very low concentration biomarkers in the blood that are released from cancers,” Beer said. “Early detection of cancer can save lives.”
Study results
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 2022. Those figures may seem small, but for most of the cancers, essentially no cases are found early today, Exact Sciences said.
In another study, involving 21 organ types, Cancerguard detected 51% of cancers overall, the company reported last month. For the six most aggressive cancers — pancreatic, esophageal, liver, lung, stomach and ovarian — the rate was nearly 64%.
The idea is to test people periodically, so cancers missed one time might be picked up the next time — still typically earlier than they’re caught today, Beer said. Such testing could “have a really big public health impact,” he said.
As Exact Sciences awaits FDA action on Cologuard Plus, which a study said finds more cancers and has fewer false positives than the original test, Geneoscopy said it expects to launch ColoSense later this year or early next year. In January, Geneoscopy asked for a federal review of the patent at issue in the lawsuit, on how fecal samples are collected and processed.
More than 14 million tests involving the original Cologuard have been performed, including nearly 4 million in 2023, with about 70,000 early-stage cancers detected and 475,000 people found to have precancerous polyps, according to Exact Sciences.
In February, Exact Sciences launched Riskguard, a blood or saliva test for hereditary risk of 10 cancers.
The company is expected this year to roll out Oncodetect, a blood test to detect molecular residual disease, tiny bits of cancer that can remain in the blood after treatment and cause recurrence of tumors.
Last week, it reported $638 million in revenue for the first quarter of this year, up 6% from the same period last year. But the company had a net loss of $110 million, or 60 cents a share, higher than the loss of 42 cents a share a year ago.
On Friday, its stock closed at $53.51 a share, down from $73.60 a month earlier.
