Abbott Labs Seeks FDA 510(k) Clearance For New Automated Ovarian Cancer Detection Test

A new diagnostic tool physicians can use to monitor patients for the most common form of ovarian cancer may soon be available in the United States.

Abbott Laboratories’ ARCHITECT HE4 assay uses a simple blood test to help in monitoring for the recurrence or progression of epithelial ovarian cancer. If approved by the FDA, this important immunoassay would be the first automated HE4 test available in the United States.

A new diagnostic tool physicians can use to monitor patients for the most common form of ovarian cancer may soon be available in the United States.  Abbott Laboratories’ (Abbott’s) ARCHITECT [Human Epididymal Protein 4] HE4 assay uses a simple blood test to help in monitoring for the recurrence or progression of epithelial ovarian cancer. If approved by the U.S. Food & Drug Administration (FDA), this important immunoassay would be the first automated HE4 test available in the United States.

The 2003 Hellstrom et al. study of known ovarian cancer biomarkers found that HE4, which has been detected in high levels in the blood of some ovarian cancer patients, shows the highest sensitivity and specificity of any other marker and is considered the best single marker for stage 1 of the disease.

According to the American Cancer Society, the five-year survival rate of ovarian cancer patients is 46 percent. However, when the disease is diagnosed and treated earlier, the survival rate increases to 93 percent. Less than 20 percent of all ovarian cancer is found in the early stage.

“The ability to monitor the recurrence or progression of ovarian cancer is a critical part of patient care. The ARCHITECT HE4 assay has the potential to be a powerful tool for both physicians and patients in the management of the disease,” said Michael Warmuth, Senior Vice President, Diagnostics, Abbott.

Abbott partnered with Fujirebio Diagnostics, Inc. in the development of the assay. The ARCHITECT HE4 assay is approved for use in Europe, as well as in other countries in Asia Pacific and Latin America. It is currently an investigational device in the United States.

About ARCHITECT HE4 Assay

The ARCHITECT HE4 assay is designed to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer, and must be used in conjunction with other clinical data. The ARCHITECT HE4 assay should not be used as a cancer screening test. In addition, certain types of cancer (e.g., mucinous or germ cell tumors) rarely express HE4, and the use of the ARCHITECT HE4 assay is not recommended for monitoring patients with those types of cancer.

About Ovarian Cancer

Ovarian cancer is the leading cause of death from gynecological cancers and the fifth-leading cause of cancer death in women. An estimated one in 71 women will develop ovarian cancer in their lifetimes. Women who are postmenopausal are at the greatest risk for ovarian cancer.

About Abbott Diagnostics

Abbott Diagnostics is a global leader in in vitro diagnostics (IVD) and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics. With more than 69,000 institutional customers in more than 100 countries, Abbott’s diagnostic products offer customers automation, convenience, cost effectiveness and flexibility. The history of Abbott Diagnostics is filled with examples of first-of-a-kind products and significant technological advancements, including the development of the very first diagnostic test to detect HIV.

About Abbott’s Diagnostics Businesses

Abbott is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics. With more than 69,000 customers in more than 100 countries, Abbott’s diagnostic products offer customers automation, convenience, bedside testing, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science through the company’s commitment to improving patient care and lowering costs.

About Abbott

Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 72,000 people and markets its products in more than 130 countries.

References:

  • FDA 510(k) Clearances – Overview, Device Approvals & Clearances, Products & Medical Procedures, Medical Devices, U.S. Food & Drug Administration, U.S. Department of Health & Human Services.

Additional Information:

Anderson GL, McIntosh M, Wu L, et. al. Assessing lead time of selected ovarian cancer biomarkers: a nested case-control study. J Natl Cancer Inst. 2010 Jan 6;102(1):26-38. Epub 2009 Dec 30. PubMed PMID: 20042715;PubMed Central PMCID: PMC2802285.

Andersen MR, Goff BA, Lowe KA, et. al. Use of a Symptom Index, CA125, and HE4 to predict ovarian cancer. Gynecol Oncol. 2009 Nov 27. [Epub ahead of print] PubMed PMID: 19945742.

Moore RG, McMeekin DS, Brown AK, et. alA novel multiple marker bioassay utilizing HE4 and CA125 for the prediction of ovarian cancer in patients with a pelvic mass. Gynecol Oncol. 2009 Jan;112(1):40-6. Epub 2008 Oct 12. PubMed PMID: 18851871.

Hellstrom I, Hellstrom KE. SMRP and HE4 as biomarkers for ovarian carcinoma when used alone and in combination with CA125 and/or each other. Adv Exp Med Biol. 2008;622:15-21. Review. PubMed PMID: 18546615.

Havrilesky LJ, Whitehead CM, Rubatt JM, et. al. Evaluation of biomarker panels for early stage ovarian cancer detection and monitoring for disease recurrence. Gynecol Oncol. 2008 Sep;110(3):374-82. Epub 2008 Jun 27. PubMed PMID: 18584856.

Moore RG, Brown AK, Miller MC, et. al. The use of multiple novel tumor biomarkers for the detection of ovarian carcinoma in patients with a pelvic mass. Gynecol Oncol. 2008 Feb;108(2):402-8. Epub 2007 Dec 3. PubMed PMID:  18061248.

Rosen DG, Wang L, Atkinson JN, et. al. Potential markers that complement expression of CA125 in epithelial ovarian cancer. Gynecol Oncol. 2005 Nov;99(2):267-77. Epub 2005 Aug 2.  PubMed PMID: 16061277.

Drapkin R, von Horsten HH, Lin Y, et. al. Human epididymis protein 4 (HE4) is a secreted glycoprotein that is overexpressed by serous and endometrioid ovarian carcinomas. Cancer Res. 2005 Mar 15;65(6):2162-9. PubMed PMID: 15781627.

2 thoughts on “Abbott Labs Seeks FDA 510(k) Clearance For New Automated Ovarian Cancer Detection Test

  1. Paul, great post as usual. I can already see the marketing machine gearing up for this one. This test has “screening” written all over it, even though the FDA submission is for monitoring of already diagnosed cases. The “off-label” marketing rules are less well defined for tests than they are for medicines, and I can remember the Oncotype DX guys overstating those claims when the test came out around 2003. Not that we don’t need a better screening test, but I suspect that’s going to be the first thing docs ask when the rep comes by, and the rep will be more than happy to oblige with half-baked information for that indication. We’ll see. Thanks for the heads-up.

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    • Michael, thank you for the kind words. I agree, the in vitro diagnostics framework is in need of serious review and modification by the FDA. First, we had the OvaSure debacle in 2008. Next, we had the Christmas season OvaDx bravado (check out hyperlink to read the Arrayit OvaDx press release). Now, we have ARCHITECT HE4, and I assume that Abbott will attempt to obtain FDA approval to market. As Yogi Berra said: “This is like deja vu all over again!” Don’t forget about the OvPlex test which is already being marketed overseas.

      When you combine the tests above, it appears a lot like the “Four Horsemen of the Apocalypse.” I strongly support research toward an ovarian cancer early detection test, but sufficient clinical trial testing should be required before these tests are marketed to the public.

      For our readers, I encourage you to visit interactMD.com. InteractMD.com is a superb medical and health news website founded by Michael Benjamin, M.D. Dr. Benjamin specializes in hematology, oncology, and internal medicine.

      Thanks again for coming by, and thank you for supporting Libby’s H*O*P*E*. Don’t be a stranger. Best, Paul

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