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Exact Sciences (Nasdaq: EXAS) | Company Profile, History, Competitors

 

Exact Sciences (NASDAQ: EXAS) provides diagnostics tests to early detect colorectal cancer and pre-cancer. Exact Sciences developed a non-invasive screening test called Cologuard for the early detection of colorectal cancer and pre-cancer. Exact Sciences also develops diagnostic tests for other types of cancers. The company was founded in 1996 and headquartered in Madison, WI.

Exact Sciences developed a non-invasive colon cancer screening tool that was approved by the FDA in 2014. As of 2017, it is currently the only FDA approved stool-based colorectal cancer test.

History

EXAS chose a joint FDA and CMS parallel pilot program for Cologuard to reduce the time between FDA approval and Medicare approval. In 2012, EXAS submitted the first module to the joint program. 

The entire process required submissions of three separate modules and completion of EXAS's DeeP-C 10,000 patient study. Cologuard received FDA/CMS approval in 2014.

In 2016, the United States Preventive Services Task Force (USPSTF) placed Cologuard on equal standing with all other colon cancer screening options.

In 2018, the company signed a joint marketing agreement with Pfizer.

Cologuard Methodology

Cologuard was developed with the Mayo Clinic. It is the only FDA approved stool-based colorectal cancer test as of 2017. 

Cologuard tests the stool sample for abnormalities. It detects methylated genes (NDRG4, BMP3), KRAS mutations, and ACTB genes.

For a patient, the Cologuard collection kit is shipped to the patient's home. The stool sample is collected and sent to Exact Sciences.

The stool sample is tested at Exact Sciences's lab in Madison, Wisconsin. The DNA is tested using Quantitative Allele-specific Real-time Target and Signal Amplification (QuARTs) technology. The detection of fecal occult blood is done using a quantitative Enzyme-Linked Immunosorbent Assay (ELISA) to determine the concentration of hemoglobin in the sample.The composite score is generated if the result is positive or negative.

The turnaround time for the test is two weeks. A positive score should be followed by a diagnostic colonoscopy.

EXAS own 31 patents and 41 pending patent applications at the end of 2017.

Colorectal Screening Market

The colorectal screening market size is 80 million patients consisting of 50 to 85 year old individuals. Roughly 49% of patients undergo colonscopy and 9% use OTC tests. Early detection can result in a 90% survival rate for Stage 1/2 patients.

Management

Kevin Conroy (CEO): Kevin Conroy serves as CEO since 2009. Prior, he was CEO of Third Wave and counsel at GE Healthcare.

Jeff Elliot (CFO): Jeff Elliot serve as CFO since 2016. Prior, he was VP Business Development at Exact Sciences. He had also served as a research analyst at Robert W. Baird

Graham Lidgard PhD (CSO): Graham Lidgard serves as Chief Science Officer since 2009. Prior, he was SVP of R&D at Nanogen and VP R&D at Gen-Probe. 

Financials

 $ USD in millions   2013 2014 2015 2016 2017
 Revenues$4 $2 $39 $99 $266 
 Gross Profit$4 ($3)$15  $54  $187 
 Operating Profit ($47)($101)($159)($169)($118)
 Net Income($47)($100)($158)($167)($114)
 EPS($0.69)($1.25)($1.71)($1.63)($0.99)

Exact Sciences Corp.
 
  Type     Public
  Ticker     NASDAQ: EXAS
  Industry Healthcare
  Founded 1995
  Headquarters Madison, WI
  Revenues
$266mm (2017)
  Employees 1,268 (2017)
  Website exactsciences.com