March 4, 2017: Sell Exact Sciences for a 55% win in 37 days. Congratulations if you were able to make money on the trade and always remember to sell your positions before you get the sell alert from me. I review more than 200 open stock positions over the weekend when I have time and so my sell signals are always going to come later.
March 2, 2017: A study from Exact Sciences Corp. and Mayo Clinic released today by the American Association of Cancer Research (AACR) shows promise for the development of a blood-based lung cancer test. Researchers conducted a multi-round study of nearly 400 patients, which demonstrated high accuracy for detecting lung cancer at all stages.
AACR released an abstract of the study today, ahead of the presentation of the results on April 2, 2017, during the AACR 2017 annual meeting. The findings from the study of 398 patients (311 controls and 87 cancers) demonstrate that biomarkers in plasma achieved high accuracy for all types and stages of lung cancer. Using two independent regression modeling approaches, a panel of four novel methylated DNA markers demonstrated a sensitivity of 91-96 percent at a specificity of 90-94 percent.
More studies are needed to corroborate accuracy, however, this plasma DNA test approach appears to be a promising new method and may serve as a rational follow-up to the common findings of lung nodules on CT scanning and may have application in screening for lung cancer.
February 21, 2017: Roth Capital raised Exact Sciences to Buy from Neutral and set a price target of $26. The price target was raised to $26 from $15. Roth Capital says Exact Sciences announced Q4 revenues in-line with its pre-announcement beat driven by strong volumes and higher ASPs, and unveiled 2017 guidance above expectations.
February 5, 2017: On February 2, 2017, Exact Sciences announced that Cologuard® is included in the Medicare Advantage Advance Notice and Draft Call letter. Cologuard’s inclusion in the final Star Ratings will allow Medicare Advantage plans to increase their Star Rating when patients complete Exact Sciences’ non-invasive colon cancer screening test.
Kevin Conroy, chairman and CEO of Exact Sciences said, “The proposed inclusion of Cologuard in the Star Ratings program is an important step toward it becoming a standard of care for colon cancer screening. Health insurers would be eligible to receive Medicare Advantage Star Rating quality credit when their members are screened using Cologuard.”
The Centers for Medicare and Medicaid Services (CMS) Medicare Advantage Star Ratings are directly impacted by the Healthcare Effectiveness Data and Information Set (HEDIS). The HEDIS quality measures were updated by the National Committee for Quality Assurance (NCQA) on October 3, 2016, to include Cologuard on an every three-year screening schedule. CMS’s proposal to broaden the colorectal cancer screening quality measure is subject to a 60-day public comment period. The proposal aligns the Star Ratings with the HEDIS quality ratings and the colorectal cancer screening guidelines of the U.S. Preventive Services Task Force, the American Cancer Society and others. Just as HEDIS 2017 quality measures are used to audit and report the 2016 performance of providers and health systems, the Stars Ratings use the HEDIS data to calculate the quality performance of Medicare Advantage plans.
January 8, 2017: Exact Sciences guides Q4 revenue from $34.9 million to $35.4 million versus the $29.5 million estimate. Q4 saw the completion of approximately 82,000 Cologuard tests during the fourth quarter of 2016, which represents growth of 114 percent from the same period of 2015.
More than 9,500 health care providers ordered Cologuard for the first time during the fourth quarter ended Dec. 31, 2016. The number of providers who have ordered Cologuard since it was launched increased to nearly 60,000 during 2016, an increase of 122 percent from the prior year.
Insurance coverage of Cologuard expanded by 67 percent during 2016. Coverage has increased by 62 million lives since June 2016, when Cologuard was included in the U.S. Preventive Services Task Force’s final colorectal cancer screening recommendations. More than 163 million people are in health plans that cover Cologuard as of January 6, 2017.
January 5, 2017: Exact Sciences announced that the Blue Cross Blue Shield Association’s (BCBSA) Center for Clinical Effectiveness “Evidence Street” recently released a positive review of Cologuard to its members. BCBSA is a national federation of 36 Blue Cross and Blue Shield companies that insure one in three Americans. This continues the positive momentum for Cologuard, as coverage increased by 67 percent in 2016 and nearly 163 million Americans are now in health plans that cover the non-invasive colorectal cancer screening option. The BCBSA’s Center for Clinical Effectiveness is an organization that assesses the effectiveness of medical devices, procedures, and biological products through comprehensive reviews and clinical evidence. The Evidence Street assessment follows other positive reviews of Cologuard, which is now included in the recommendations of the U.S. Preventive Services Task Force, and the colorectal cancer screening guidelines of the American Cancer Society and the National Comprehensive Cancer Network. This assessment is influential for association members and non-members who look to the Center for Clinical Effectiveness for guidance. BCBSA does not endorse specific companies or products nor make coverage decisions.
December 12, 2016: Exact Sciences announced today under a recently-signed contract, Humana Inc. agreed to cover Cologuard as an in-network service for its members, effective January 1, 2017. Under terms of the agreement, Cologuard will be available to most Humana beneficiaries with no co-pay. Humana covers nearly 10 million recipients and is the nation’s fifth-largest commercial insurer.
With Humana’s inclusion of Cologuard as an in-network service, the test is now covered by a cross-section of health plans nationwide with more than 153 million members. This is an increase of more than 50 million members since June 2016 when Cologuard was included as an A-rated service in the colorectal cancer screening guidelines of the U.S. Preventive Services Task Force. More than 68 percent of Cologuard’s addressable population are enrolled in plans that cover the test.
Exact Sciences Corp. is a molecular diagnostics company focused on colorectal cancer. The company has exclusive intellectual property protecting its non-invasive, molecular screening technology for the detection of colorectal cancer. Stool-based DNA technology is included in the colorectal cancer screening guidelines of the American Cancer Society and the U.S. Multi-Society Task Force on Colorectal Cancer.
