Proposed Alternative Laboratory Test Approval Methods Could Help Offset Impact of Future Federal Regulations.Business Editors/Health/Medical Writers PALO ALTO Palo Alto, city, California Palo Alto (păl`ō ăl`tō), city (1990 pop. 55,900), Santa Clara co., W Calif.; inc. 1894. Although primarily residential, Palo Alto has aerospace, electronics, and advanced research industries. , Calif.--(BUSINESS WIRE)--Dec. 15, 2003 The Food and Drug Administration is looking to reassess reassess Verb to reconsider the value or importance of reassessment n Verb 1. reassess - revise or renew one's assessment reevaluate regulations involving the marketing and use of analyte specific reagents The FDA defines analyte specific reagents (ASRs) in 21 CFR 864.4020 as “antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with (ASRs) within the reference laboratory market. Currently, manufacturers of ASRs, which are the building blocks of most gene-based tests, cannot include any claims of clinical utility, specific clinical performance characteristics, or recipes for laboratory home-brew on product labels. New analysis from Frost & Sullivan (http://www.healthcare.frost.com), U.S. Reference Laboratory Markets, reveals that revenues generated within this industry at the total market level were $12.8 billion in 2002. Total market revenue is expected to reach $17.3 billion in 2009. Manufacturers are also restricted from selling ASRs to any reference laboratory other than those that hold a certificate of moderate to high complexity from CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a , the Clinical Laboratory Improvement Amendments Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. program. "The Food and Drug Administration hopes to implement regulations that will facilitate the establishment of clinical validity of new assays utilizing ASRs, while ensuring that pre-market approval procedures do not hamper future test development," states Frost & Sullivan Research Analyst Laura Meier. Some market participants The term market participant is used in United States constitutional law to describe a U.S. State which is acting as a producer or supplier of a marketable good or service. When a state is acting in such a role, it may permissibly discriminate against non-residents. , especially ones developing high-margin esoteric tests esoteric test Lab medicine The analysis of 'rare' substances or molecules that are not performed in a routine clinical lab. See DORA. , are attempting to push for alternative 510(k) approvals for tests involving ASRs. Their proposed approval process is an attempt to provide manufacturers with an opportunity to establish analytical validity of testing methods, which could allow them to provide specific home-brew recipes to laboratories. If ASRs are used in a standardized standardized pertaining to data that have been submitted to standardization procedures. standardized morbidity rate see morbidity rate. standardized mortality rate see mortality rate. way, the clinical validity of new assays could potentially be verified through normalization In relational database management, a process that breaks down data into record groups for efficient processing. There are six stages. By the third stage (third normal form), data are identified only by the key field in their record. of test trial data. Establishing the clinical validity of new tests could also facilitate approval for reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. of these higher-margin esoteric tests by managed care organizations. Within the routine testing segment, however, reimbursement rates are poised to remain low since managed care organizations, physicians, and government entities view these tests as commodity products. This status makes it difficult for reference laboratories to charge more for routine tests, thereby narrowing the segment's profit margins. By transitioning to fully automated systems in routine testing laboratories, however, market participants can focus valuable research and development budgets on more profitable, higher-margin tests. "Although the initial expenditure of automated systems can be quite steep, the cost benefits are immediate -- analysis of a higher volume of samples with fewer personnel and less reagents in reduced time," notes Meier. Strategies for reference laboratories to cut costs will become vital in the near future. In November 2003, a Medicare legislative agreement was announced that, while deciding against a proposed 20-percent laboratory co-payment for Medicare recipients, delivered an equally devastating dev·as·tate tr.v. dev·as·tat·ed, dev·as·tat·ing, dev·as·tates 1. To lay waste; destroy. 2. To overwhelm; confound; stun: was devastated by the rude remark. blow to the industry: a seven-year freeze on laboratory fee schedule consumer price index (CPI (1) (Characters Per Inch) The measurement of the density of characters per inch on tape or paper. A printer's CPI button switches character pitch. (2) (Counts Per I ) updates. The reference laboratory market has already suffered through one such freeze, receiving only one CPI update of 1.1% in the last six years. "A lack of laboratory fee schedule CPI updates and a decrease in NLAs has resulted in Medicare reimbursement rates that are now lower than they were ten years ago. The announcement of additional freezes over the next seven years is sure to threaten the viability of smaller market participants who lack the economies of scale required to stay afloat in an industry of diminishing profit margins," observes Meier. The U.S. Reference Laboratory Markets, a part of the Clinical Diagnostics subscription, examines some of the most pressing challenges in the laboratory market and provides strategic recommendations to overcome them. This research service is segmented into routine, esoteric, and clinical trials testing markets. Interviews are available to the press. If you are interested in an analysis overview which provide manufacturers, end-users and other industry participants an overview, summary, challenges and latest coverage of the U.S. Reference Laboratory Markets -- then send an email to Danielle White Danielle Marie White (born February 2, 1992 in Cincinnati, Ohio) is an American singer who was raised in Bradenton, Florida. In 2003, White appeared on the reality television series American Juniors -- Healthcare Media Relations Executive at dwhite@frost.com with the following information: Full name, Company Name, Title, Contact Tel Number, Contact Fax Number, Email. Upon receipt of the above information, an overview will be emailed to you. Frost & Sullivan, an international growth consultancy, has been supporting clients' expansion for more than four decades. Our market expertise covers a broad spectrum of industries, while our portfolio of advisory competencies includes custom strategic consulting, market intelligence, and management training. Our mission is to forge partnerships with our clients' management teams to deliver market insights and to create value and drive growth through innovative approaches. Frost & Sullivan's network of consultants, industry experts, corporate trainers A corporate trainer is a specialized skill development position in a corporation where the goal is to help improve the "soft skills" or "people skills" of the workers in the corporation. , and support staff spans the globe with offices in every major country around the world. U.S. Reference Laboratory Markets A555 Keywords in this release: U.S. reference laboratory, Food and Drug Administration, analyte-specific reagents, ASRs, Clinical Laboratory Improvement Act-certified clinical laboratories |
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