Cancer test OK required by FDA; EXACT stock down 22 percent.Byline: Bob Kievra MARLBORO Marlboro or Marlborough (märl`bərō), city (1990 pop. 31,813), Middlesex co., E Mass.; settled on the site of a Native American village 1657, inc. as a city 1890. - Shares of cancer test developer EXACT Sciences Corp. tumbled yesterday, one day after disclosing the Food and Drug Administration said the company's colon cancer colon cancer, cancer of any part of the colon (often called the large intestine). Colon cancer is the second most common cancer diagnosed in the United States. test needs regulatory approval. The biotechnology company saw its stock drop 22 percent, closing down $1.30 to $4.72 a share in heavy volume of 3.1 million shares on the Nasdaq Stock Market Nasdaq stock market The first electronic stock market listing over 5000 companies. The Nasdaq stock market comprises two separate markets, namely the Nasdaq National Market, which trades large, active securities and the Nasdaq Smallcap Market that trades emerging growth companies. . EXACT Sciences said Tuesday night the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. believes the company's PreGen-Plus product, which looks for genetic information in stool samples to determine if a person might have colon cancer, is a medical device which requires premarket approval premarket approval Medical devices A scientific and regulatory review by the FDA to ensure the safety and effectiveness of a Class III device, before its approval for marketing. See Advisory panel, Medical device. or clearance. Company officials, in a conference call yesterday with investors, said the FDA request came as a surprise, particularly since the test has been on the market since August 2003 under a so-called "homebrew" FDA exemption. "This is a setback right now, but if we get to the other side, we think we'll be in good shape,'' President Jeffrey R. Luber said in an interview. A potential FDA filing has always been part of the company's long-term strategy, an effort that will now be accelerated, Mr. Luber said EXACT Sciences licenses the tests to Laboratory Corp. of America, which has received approximately 12,500 patient samples since it was launched in August 2003 and Dec. 31, 2006. Laboratory Corp.'s sales of PreGen-Plus represents EXACT Sciences' primary source of revenue. EXACT Sciences posted a net loss of $12.9 million, or 49 cents per share Cents per share The amount of a mutual fund's dividend or capital gains distributions that a shareholder will receive for each share owned. , on $4.8 million in revenues for the year ending Dec. 31. In a statement, Laboratory Corp. spokeswoman Donna F. Schuetz said, "at this time we are comfortable and will continue to offer the test.'' Mr. Luber said a pending Medicare application likely prompted the Centers for Medicare and Medicaid Services The Centers for Medicare and Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and to contact the FDA about the EXACT Sciences test. The company has always intended to seek FDA approval, but was awaiting a decision on new colon cancer screening guidelines from the American Cancer Society American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, . Those guidelines, which were expected in 2006, may hold the key to EXACT Sciences' fortunes. The guidelines are now projected for release in November. The tests, which cost between $300 and $500, have not been widely adopted by employers, insurers and doctors because they are currently not included in cancer screening guidelines cancer screening guideline Any guideline promulgated by an authoritative organization–eg Am Cancer Society, for early detection of a malignancy common in a particular population, the diagnosis of which, if caught early, results in a complete cure or improved . Mr. Luber said the company has a meeting scheduled with the FDA and will be filing an application for approval of the screening technology as soon as possible. Mr. Luber said he will know more at a later date about what type of specific FDA filing will be required and whether existing studies by EXACT Sciences will suffice. Colon cancer is the second-leading cause of cancer death in the United States and researchers believe that fewer than 50 percent of the 80 million people over the age of 50 have been screened. |
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