Exact Sciences Corp., of Madison, Wis., detailed three studies of the Oncotype Dx Breast Recurrence Score test during the virtual 2020 American Society of Clinical Oncology Annual Meeting. According to the company, the findings highlight the value of the test for personalizing and improving neoadjuvant treatment decisions in women with hormone receptor positive, HER2-negative breast cancer.

Emilio Alba, director of the medical oncology units at the Hospital Universitario Virgen de la Victoria in Malaga, Spain, said these results hold special importance, given that screening and diagnostic oncology services are being delayed in the wake of COVID-19. "This new evidence shows that the Oncotype Dx test may be used to inform neoadjuvant therapy while awaiting surgery, therefore helping us to overcome some of the unique challenges we are currently facing in managing breast cancer patients,” he added.

Steve Shak, the company's chief medical officer, told BioWorld that the data backs the potential for oncologists to shift tumors with low Recurrence Score results to hormonal treatments as opposed to chemotherapy in the neoadjuvant setting. “Exact Sciences will continue to support research in the neoadjuvant setting and will report new data on the utility of core biopsies for Oncotype Dx testing later this year,” he continued.

Like Alba, Shak highlighted the relevance of the results amid the pandemic. "To date, Oncotype Dx has served as a useful tool to help oncologists safely treat patients at this time. The COVID 19 Pandemic Breast Cancer Consortium (formed by representatives from the American Society of Breast Surgeons, the National Accreditation Program for Breast Centers, the National Comprehensive Care Network, the Commission on Cancer, and the American College of Radiology) updated their guidelines to recommend guiding neoadjuvant treatment decisions for newly diagnosed patients with a Recurrence Score result.”

This result can help determine who can be treated with only hormone therapy and postpone surgery to a safer time. “In recent months, we have seen the percentage of core biopsies submitted for testing has increased by almost 50%, highlighting the added value of Oncotype Dx in this setting, as well as the impact on clinical practice in light of the COVID-19 pandemic,” he added.

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

"The Exact Sciences and Genomic Health teams have built two of the strongest and fastest-growing brands in our industry, Cologuard and Oncotype Dx," Kevin Conroy, Exact Sciences' CEO, said at the time. "The combined company will have an even stronger platform for the continued growth of our leading products and the development of our pipeline."


Results of one of the studies presented came as a result of the assessment of 76 women treated with neoadjuvant chemotherapy from the Young Women's Breast Cancer Study. That included a prospective group of women diagnosed with breast cancer at age 40 or younger. The test was performed on tumor specimens from core biopsies obtained before surgery, and results revealed 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 prospectively analyzed 63 patients who received neoadjuvant chemotherapy following testing on tumor specimens from core biopsies. An analysis showed a strong correlation between the pCR and Recurrence Score result. Of note, the Recurrence Score result was the most significant predictor of pCR when compared to other factors, such as Ki67, estrogen receptor status, and initial tumor size.

A final 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. After four months of treatment, data from 142 patients showed that 97% of them had a clinical response or stable disease, suggesting that patients with a Recurrence Score result <31 can be offered neoadjuvant endocrine therapy alone with minimal risk of disease progression.

The meeting also saw the presentation of abstracts related to a collaboration between Exact Sciences and the Mayo Clinic to identify biomarkers associated with different cancer types. The highlighted cancer types are early-stage hepatocellular carcinoma, pancreatic neuroendocrine tumors, distant recurrence of colorectal cancer, ovarian cancer and metastatic melanoma.


During its May 6 first-quarter earnings call, the company noted that precision oncology saw revenues of $128 million. “[The] first quarter benefited from the timing of Oncotype Dx breast test volumes in the U.S.,” noted CFO Jeff Elliott. “Some patients are delaying surgery because of COVID-19 fears and completed Oncotype testing earlier to help inform them whether to use chemotherapy on a neoadjuvant basis,” he added.

With that said, the company has predicted a widespread decrease in screening mammograms as a result of COVID-19. That is expected to have a negative impact on volumes over the next few months through the typical lag between a mammogram and an Oncotype Dx test.

Still, in a May 23 note, William Blair analyst Brian Weinstein said he saw a range of opportunities in a post-pandemic world, particularly with the company’s Cologuard test. “First, obviously the idea of at home screening versus screening requiring a trip to a hospital or surgery center should resonate clearly at this point (to say nothing of the lack of fasting, drinking that awful liquid for the cleansing, taking a day off of work, etc.),” he wrote. “But for those who were scheduled for a colonoscopy (up to 500,000 people per month), there is limited capacity to get these people rescheduled, and we believe GIs may look to Cologuard as a way to help ease the backlog.”

The company’s screening business, of which Cologuard is a key part, saw quarterly revenue of $219 million, an increase of 35%, driven by test volume growth.

Also of note, the company filed a prospectus dated June 1 as part of a registration statement on Form S-3 utilizing a shelf registration process. It said it intends to use the estimated net proceeds from the sale of these securities for general corporate and working capital purposes, including to fund expansion of commercialization activities and to fund product development efforts.