Medicare Adds Coverage of Annual InSure Testing to Colorectal Cancer Screening Benefit; Innovative, Patient-Friendly Screening Test Now Available to Medicare Beneficiaries.

Business Editors/Health/Medical Writers

FALMOUTH, Maine--(BUSINESS WIRE)--Nov. 5, 2003

Enterix Inc. announced today that the Centers for Medicare and Medicaid Services (CMS) has issued a National Coverage Decision Memorandum for the use of immunochemical fecal occult blood tests, including its InSure(TM) Fecal Immunochemical Test (FIT), as a method to screen for colorectal cancer. The decision will allow Medicare beneficiaries to use the InSure brush-sampling test annually after they reach the age of 50. This action represents the first expansion of the preventive colorectal cancer screening benefit by Medicare since Congress enacted The Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000.

CMS issued this decision memorandum in response to a coverage request submitted by Enterix and a number of renowned clinical experts in the field of colorectal cancer screening. The InSure FIT received premarketing clearance from the United States Food and Drug Administration in January 2001. InSure is available to physicians nationally through Quest Diagnostics (NYSE: DGX), the nation's leading provider of diagnostic testing, information and services.

"This decision is an important step to increase the rate of colorectal cancer screening among Medicare beneficiaries. Colorectal cancer is a preventable disease if it is detected early through regular screening. InSure makes annual screening easier for patients, while providing physicians with accurate, immunoassay-based information," said Neil Schlackman, MD, Medical Director for Enterix.

"We are extremely gratified with this favorable Medicare coverage decision for InSure," said Craig P. Sands, President and Chief Executive Officer of Enterix. "We have worked closely with the agency in support of their careful consideration of our request that InSure be added to the Medicare colorectal cancer screening benefit. We are optimistic that InSure will help to reduce the number of colorectal cancer deaths from the current level of 57,000 per year, where it has remained for the past ten years. This coverage decision is a significant step forward for the 40 million older Americans who rely on Medicare for their healthcare, and is an example of how the Medicare program integrates innovative medical technology into existing treatment and prevention efforts."

"The only remaining barrier to Medicare beneficiary utilization of InSure is the establishment by CMS of an appropriate reimbursement rate adequate to support commercialization of InSure. We remain hopeful that the pricing level to be announced by the agency will further support this positive coverage decision," added Sands.

CMS took the unprecedented step of explicitly considering cost-effectiveness in arriving at this national coverage decision. As part of the decision process, CMS requested a cost-effectiveness analysis from the Agency for Healthcare Research and Quality (AHRQ), a division of the United States Department of Health and Human Services. This report, issued August 26, 2003, concluded that immunoassay tests, such as InSure, provide a very cost-effective intervention for reducing colorectal cancer incidence and mortality.(1) The AHRQ report further concluded that InSure was cost-effective at a reimbursement rate of $28.00 under a wide range of test performance assumptions.

In a report issued last year, the United States General Accounting Office found that colorectal cancer screening is the least utilized preventive health benefit available to Medicare beneficiaries. As is the case in the general population, only 25% of Medicare beneficiaries are screened each year with traditional guaiac fecal occult blood tests (FOBTs), compared wit h much higher rates for other regular cancer screening tests such as mammography (75%) or Pap smear testing (66%).(2)

The InSure FIT addresses all of the shortcomings of traditional guaiac-based FOBTs, which use a 35-year-old chemical detection method that often yields inaccurate test results (false positives and false negatives). With InSure, a simple brush is used to collect toilet water from around the stool, rather than actual fecal samples. Unlike guaiac FOBTs, the InSure FIT does not react with non-human blood (red meat), vitamins (vitamin C), drugs (nonsteroidal anti-inflammatory drugs) or foods (certain vegetables). Therefore, patients do not need to restrict their diets or change medications before or during the two-day sample collection period with the InSure FIT.

By using advanced immunological detection, InSure specifically identifies trace bleeding from the colon and rectum, where colorectal cancer originates. Guaiac FOBTs cannot differentiate between bleeding from the colon and rectum, and bleeding from other parts of the gastrointestinal tract, such as the stomach, esophagus and mouth. Clinical data shows InSure to be 87% sensitive for colorectal cancer, which is significantly higher than any other currently available non-invasive screening test.(3)

In recognition of the importance of improved colorectal cancer screening methods and the need to increase compliance with colorectal cancer screening guidelines, the National Committee for Quality Assurance (NCQA) has added a new quality measure for colorectal cancer screening to its 2004 Health Plan Employer Data and Information Set (HEDIS(R)). This tool is used to measure health plan performance in key areas like immunization and cancer screening rates. The new HEDIS colorectal cancer screening measure recognizes FITs, such as InSure, as a qualifying annual screening method.(4)

About Colorectal Cancer

Colorectal cancer is the second-leading cause of cancer-related deaths in the United States. In 2003, approximately 147,500 new cases of colorectal cancer will be diagnosed in the United States, and an estimated 57,100 Americans will die from the disease. However, with regular screening, colorectal cancer can be found early, when treatment is most effective, increasing the survival rate to more than 90%.

About Enterix Inc.

Enterix Inc., an international cancer screening company, is dedicated to helping physicians and their patients screen for life-threatening diseases such as cancer and diseases of aging. The first product developed for Enterix' proprietary screening platform is the InSure Fecal Immunochemical Test, for the detection of early warning signs of colorectal cancer. Enterix has also identified and filed patent applications covering novel genomic markers that identify the development of pre-cancerous adenomatous polyps in the colon and rectum.

Founded in 1997, Enterix maintains operations in Falmouth, Maine, USA and in Sydney, Australia. Detailed information on Enterix can be found on the web at www.insuretest.com. Enterix can be reached at 1-800-531-3681 (USA), 1-800-55-65-75 (Australia) or by e-mail at [e-mail].

References:

(1) van Ballegooijen M, Habbema JDF, Boer R, Zauber AG, Brown ML.

Report to the Agency for Healthcare Research and Quality: A

comparison of the cost-effectiveness of fecal occult blood 

tests with different test characteristics in the context of

annual screening in the Medicare population. August 9, 2003.

Available for download at:

www.cms.hhs.gov/mcd/viewtechassess.asp?id=87

(2) General Accounting Office, Medicare - Beneficiary Use of

Clinical Preventive Services, Report No. GAO-22-422; April

2002.

(3) U.S. Food and Drug Administration (FDA) submission data; 2000.

(4) NCQA, Washington, DC. HEDIS(R) 2004, Volume 2: Technical

Specifications. Table E5-A, page 89.

HEDIS(R) is a registered trademark of NCQA, Washington, DC.