A leader in the cancer diagnostics space with a focus on early detection, Exact Sciences (NASDAQ:EXAS) had a successful 2019, with 78% year-over-year revenue growth of its key cancer screening product, Cologuard. Cologuard is an at-home non-invasive first-line test that detects colon cancer. If the test is positive, it indicates a colonoscopy is needed; if it's negative, the person can avoid a colonoscopy.

The number of Cologuard screenings performed in the year saw a huge increase -- a total of more than 1.68 million, more tests than were done in 2017 and 2018 combined. Revenue has also increased steadily in recent years, showing that the company is well positioned for long-term success. If management continues to execute effectively, the company should be set up to achieve its growth targets.

A clipboard with paper that says Diagnosis: Colectoral Cancer

Image source: Getty Images.

The table below highlights the significant growth in the Cologuard business in recent years, a trend that may continue into the new year. 

Metric

2017

2018

2019

Revenue

$265.5 million to $266.5 million

$454 million to $455 million

$809.5 million to $810 million

Cologuard testing volume

571,000

934,000

1.68 million

Data Source: Exact Sciences.

More providers, more profits

One of the keys to Exact Sciences' success lies with the adoption of the Cologuard screening tool among healthcare providers, a metric that's seen significant growth in the past year. There were more than 50,000 new healthcare providers offering this screening to patients in 2019, up 34% from over a year ago, and there are significant growth opportunities in the primary care space. That's exciting news for investors, who could profit as the company targets primary care, gastroenterology, and other medical specialties.

So far, Cologuard accounts for 5.4% of the U.S. colorectal cancer screening market; management hopes to capture an additional 40% of the market in the longer term. Recently, the American Cancer Society lowered the initial recommended age for colorectal screening to 45 from 50, which offers some mid-term growth opportunities for Exact Sciences, given the 19 million people in the 45 to 49 age demographic. 

Genomic Health acquisition expands global presence

At the end of 2019, Exact Sciences acquired Genomic Health, giving the former a presence in precision oncology with the Oncotype DX diagnostic test (which also broadens Exact's presence internationally). Preliminary quarterly results showed 16% year-over-year revenue growth in precision oncology, with reported revenue of $455 million to $456 million from more than 156,000 Oncotype DX tests performed in 2019. 

As CEO Kevin Conroy noted in his presentation at the J.P. Morgan Healthcare Conference, the Oncotype DX test predicts whether a woman with breast cancer will benefit from chemotherapy, and it also determines the likelihood of recurrence in early stages. This is significant because it allows the patient to understand whether chemotherapy treatment is right for them. The test has been recommended by the American Society of Clinical Oncology, the National Comprehensive Cancer Network, the European Society for Medical Oncology, the St. Gallen International Breast Cancer Conference, and the National Institute for Health and Care Excellence.

Conroy predicts that this test should drive about $100 million of adjusted EBITDA (earnings before interest, taxes, depreciation, and amortization), and he sees a large opportunity internationally in particular, with the current market seeing 14% adoption for breast cancer screening. This potential international growth is an exciting development for investors.

In addition, the Oncotype DX test will allow Exact Sciences to enter the field of urology, particularly prostate cancer. Investors should note that there is currently 15% adoption in the U.S. market and there's significant opportunity for Exact Sciences to expand in diagnostics of prostate cancer. The domestic and international expansion offered by the precision oncology business should provide the growth needed for the company to position itself for long-term success. 

Mayo partnership should improve R&D

Exact Sciences has partnered with the Mayo Clinic for more than a decade, over which time the company has expanded its study into more than 15 cancers. The collaboration provides Exact Sciences the opportunity to screen for liver, pancreatic, esophageal, bladder, and other forms of cancer. A current focus is on the development of a liquid biopsy test to detect cancer earlier and guide treatment.

For investors, this partnership matters to the health stock because of the ongoing collaboration it allows with leading scientists. Conroy noted that the company has allocated $200 million to research and development this year, showing a commitment to leadership in the cancer diagnostics space for years to come. 

Healthcare investors should be tuned in for updates from Exact Sciences in 2020 whether it's doing new deals, growing its market share for Cologuard, or entering new markets.