Time is of the essence when treating patients with advanced or metastatic cancer, and diagnostic insights can inform treatment plans. To that end, Exact Sciences Corp. has launched its Oncotype MAP Pan-Cancer Tissue test for patients with advanced, metastatic, refractory or recurrent cancer. From a small tissue sample, the test detects genomic alterations in hundreds of cancer-related genes, helping doctors better depict a patient’s tumor and recommend effective therapies or clinical trials.

“Patients with advanced cancer need answers fast, and providing them with actionable results in days, rather than weeks, is critical for improving their outcomes,” said Kevin Conroy, Exact Sciences’ chairman and CEO.

Each year in the U.S., more than 500,000 patients and their doctors face the challenges of treating and managing advanced cancer.

Small sample, quick results

The Oncotype MAP (Molecular Assessment Panel) test uses next-generation sequencing and immunohistochemistry to provide results from samples as small as 3 mm of tissue or two to three slides. The turnaround time is three to five business days, according to the company.

The Oncotype MAP test report can be interpreted alongside National Comprehensive Cancer Network Compendium-based recommendations and supports clinical decision-making with actionable biomarkers associated with more than 100 evidence-based therapies, more than 45 combination therapies and in excess of 650 active clinical trials.

“The systemic treatment of patients with advanced or metastatic cancer is challenging,” said Rick Baehner, chief medical officer of precision oncology at Exact Sciences. “Oncotype MAP is a tissue-based assay [that] delivers results regarding the underlying biology of a patient’s cancer and provides therapeutic and clinical trial options. Genomic results guide clinicians to individualize and optimize oncology therapy by targeting patient tumor biology with the most effective therapies.”

Based on a study with an earlier version of the test, patients who utilize Oncotype MAP have a significantly greater rate of progression-free survival than patients who don’t get the test – 43% vs. 5%, respectively.

“Exact Sciences is pursuing life-changing answers that give people the clarity to take action earlier,” said Conroy. “Our growing precision oncology portfolio and the addition of the Oncotype MAP test allow us to do just that for patients fighting late-stage or metastatic cancer.”

Oncotype MAP is available on order by physicians in the U.S. The test is covered by Medicare for qualifying members. Coverage by private insurers varies by plan and member benefit level.

Based in Madison, Wis., Exact Sciences is developing a line of screening and diagnostic tests that build on its Cologuard test for colorectal cancer and the Oncotype Dx tests.

Expanding precision oncology portfolio

In May, the company reported additional data from a prospective clinical survey demonstrating the clinical value of Oncotype Dx Breast Recurrence Score test. The survey – conducted in Argentina, Colombia, Mexico and Peru – included patients treated before and after the TAILORx study and revealed a 36% net decrease in chemotherapy recommendations among patients with node-negative disease.

Details from three other studies of Oncotype Dx were presented at the virtual 2020 American Society of Chemical Oncology Annual Meeting in June. An assessment of 76 women treated with neoadjuvant chemotherapy from the Young Women’s Breast Cancer Study found that patients with a higher Recurrence Score result were more likely to achieve a pathologic complete response (pCR) with chemotherapy.

A separate Spain-based study showed a strong correlation between pCR and recurrence score result in 63 patients who received neoadjuvant chemotherapy following testing on tumor specimens from core biopsies. A third study involved the Oncotype Dx test being performed prior to surgery and saw patients with recurrence score results 0-30 receiving neoadjuvant endocrine therapy without chemotherapy.

Results with the company’s prostate cancer test, Oncotype Dx Genomic Prostate Score (GPS), which were published in June, also demonstrated value. In that study, patients with unfavorable intermediate (UFI)-risk prostate cancer with a test result greater than 40 had outcomes consistent with high-risk disease and a high prognosis, suggesting they may benefit from more aggressive therapies. The reverse was true for patients for UFI-risk patients with a GPS value below 40.

Exact Sciences obtained the Oncotype Dx tests for breast and prostate cancer in 2019 through its acquisition of Genomic Health Inc., of Redwood City, Calif.

No Comments