NEW YORK – Exact Sciences' quest to cover every inch of the cancer diagnostics market isn't over yet. On Tuesday, the company announced it had acquired PFS Genomics, a firm that has developed a test to determine the necessity of radiotherapy for early-stage breast cancer patients.
"Studies show that the majority of patients who get radiation therapy are unlikely to benefit from it. The challenge is knowing who is likely to benefit and who isn't," Kevin Conroy, Exact chairman and CEO, said on a conference call to discuss the firm's first quarter earnings. PFS Genomics has identified a gene expression signature, he explained, to predict whether early-stage invasive breast cancer patients treated with breast-conserving surgery are likely to benefit from additional radiotherapy.
He compared the PFS test to Exact's Oncotype DX breast recurrence score test, which can help clinicians decide whether breast cancer patients will benefit from chemotherapy, and further noted that PFS' technology could provide help to more than 100,000 women in the US and double that many internationally.
The deal continues a trend for Exact Sciences that started with its $2.8 billion acquisition of Genomic Health in July 2019. At that time, Conroy said the merger would "create an organization with a breadth of capabilities that doesn't exist today," and that the combined company would be well positioned to bring together complementary capabilities to create leading cancer diagnostics.
The following February, Exact acquired Paradigm Diagnostics, which had developed an NGS-based cancer diagnostic test to aid in therapy selection, and Viomics, a molecular diagnostics company that specialized in biomarker selection for cancer diagnostics. Conroy said these deals were integral to the development of the company's liver cancer test.
Indeed, Conroy said on Tuesday's call that the liver cancer test, Oncoguard Liver, is being made available to healthcare providers and patients this week. The blood test has demonstrated high sensitivity in detecting early-stage hepatocellular carcinoma, he said.
The test, developed with the Mayo Clinic, was assessed in multiple studies and showed enhanced sensitivity and specificity for early-stage disease. The company expects to publish results of validation studies by year-end. The goal of making Oncoguard Liver available now is "to generate real-world evidence to support guideline inclusion, broad reimbursement, and adoption over time," Conroy said.
He also specified that the test isn't likely to received Medicare coverage for another 18 months, giving the company a chance to work with partner health systems, individual physicians, patients, patient advocacy groups, and even pharmaceutical companies to get it adopted as a new standard of care.
Last October, Exact also acquired Thrive Earlier Detection and Base Genomics. Thrive's technology is being used in Exact's development of a blood-based, pan-cancer test that could eventually be used routinely in every part of a cancer patient's care, from diagnosis to residual disease testing to therapeutic decision-making. Base Genomics' epigenetics expertise and DNA methylation analysis technology, on the other hand, are enhancing Exact's efforts in cancer diagnostics across its product portfolio.
The buying spree continued this February when the company acquired sequencing lab Ashion Analytics from the Translational Genomics Research Institute as part of its strategy to build an end-to-end cancer testing pipeline, including diagnostics for minimal residual disease.
Given the breadth of assets Exact has collected, Conroy was asked on the earnings call whether the company had specific criteria that it uses to evaluate potential acquisitions.
"We start by asking a simple question: Can we offer a new test or technology that will significantly impact patient care?" Conroy said. "The PFS deal is an example of that. We believe it's going to dramatically change how certain patients with breast cancer are treated."
He noted that the company is trying to build the broadest and most advanced capabilities, relationships, scientific platform, and commercial organization, and to bring better tests, services, data insights, and artificial intelligence to physicians and patients.
"So, that's how we look at this at a higher level. Does it impact the mission of moving to cancer eradication?" he said. "And there are many opportunities that come our way, that are great companies with tremendous tests or technologies, that we pass because they don't really fit into that framework."
In a note to investors on Wednesday, William Blair analyst Brian Weinstein said the PFS acquisition would add a new product to Exact's breast cancer franchise that potentially could add several hundred million dollars of revenue to the company's business over time.
"As this deal highlights, the pace of M&A at Exact Sciences continues to be indicative of a management team that is aggressively investing in assets to support its broader plans of being the leader in the advanced cancer diagnostics space," he wrote. "We see Exact Sciences as a clear leader in the just emerging precision oncology segment of diagnostics, with an unrivaled infrastructure built out to support the many initiatives being pursued."