Industry Trends

Inside the Diagnostics Industry: Guardant Health Takes Aim at Exact Sciences’ Leadership of Colorectal Cancer Market

Colorectal cancer is a key segment of the U.S. and world diagnostics market that generates billions of dollars in test revenues per year and is projected to grow at an annual rate of nearly 6 percent. Although the space is crowded, Exact Sciences is one of if not the leading firms in the market, particularly the colorectal minimal residual disease segment (MRD). However, in recent months, one firm has made particularly aggressive moves to challenge Exact Sciences for share of the MRD market: Guardant Health.

Exact Sciences’ Acquisition of Ashion Analytics

On Feb. 17, 2021, Exact Sciences announced that it has reached an agreement to acquire Ashion Analytics from the Translational Genomics Research Institute (TGen) for an undisclosed price. Ashion is a CLIA-certified and CAP-accredited sequencing laboratory whose genomic testing assets will bolster Exact’s efforts to enhance its Cologuard product and develop new precision oncology diagnostics for MRD and other cancers. Those Ashion assets include the GEM ExTra comprehensive cancer test, as well as whole-exome, matched germline and transcriptome sequencing capabilities.

The Ashion acquisition, which is scheduled to close in the second quarter, is just one element of Exact’s larger strategic collaboration with TGen. A month earlier, the Wisconsin-based molecular diagnostics firm announced that it had signed a worldwide exclusive license to TGen’s Targeted Digital Sequencing (TARDIS) technology, which will now be incorporated into Cologuard. The collaboration also includes 10-year research agreement for development of patents and clinical evidence to support the scientific reliability of MRD testing necessary to secure coverage from payors.

Guardant Health Takes on Cologuard

Guarant Health seems to be emerging as Exact’s principle rival in the MRD market. Last year at this time (February 2020), Guardant, which produces its own Guardant360 liquid biopsy assay for MRD, unveiled plans to invest heavily in new products to take on Cologuard and cash in on “significant market opportunities” in the colorectal and MRD space. In 2019, the Redwood, CA-based precision oncology firm launched its Lunar assay, but only for research and drug development use. Meanwhile, stronger than expected Guardant360 sales helped minimize net losses generated by the firm’s stepped-up research and development efforts.

On the very same day that Exact announced that it was acquiring Ashion, its rival launched Guardant Reveal, a commercial version of the Lunar assay. Guardant claims that the new test is the first blood-only liquid biopsy test for detection of residual and recurrent disease from a simple blood draw. According to the firm, the new test improves management of early-stage colorectal cancer patients by detecting circulating tumor DNA in blood after surgery to identify patients with MRD who may benefit most from adjuvant therapy and by detecting recurrence months earlier than current standard of care methods like imaging or carcinoembryonic antigen (CAE) tests.

Takeaway

At this point, Exact Sciences and Guardant Health are not so much competing for as sharing the colorectal and MRD market. Cologuard still reins supreme in screening. But Guardant is spending big bucks to develop a rival screening product to compete with Cologuard. Meanwhile, dual residual and recurrence capabilities of the new Guardant Reveal product move the company deeper into the cancer care pathway. But just as Guardant is working to close the gap with Exact in screening, Exact is collaborating with TGen to expand its presence in colorectal and MRD cancer treatment and case management.

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