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IVD Procedure Volume and Pricing Analysis are Available in New Kalorama Information Report

21 Feb 2013 • by Natalie Aster

The Institute of Medicine (IOM) recommended eight women’s preventive health services to be added to the services that health plans will cover at no cost to patients under the Patient Protection and Affordable Care Act (ACA) of 2010. According to the report “IVD Procedure Volume and Pricing Analysis” by Kalorama Information these eight services are: screening for gestational diabetes; human papilloma virus (HPV) testing as part of cervical cancer screening for women over 30; and counseling on sexually transmitted infections; counseling and screening for HIV. Medicare covers HIV screening for at risk groups, and over the years, as part of its preventive push, the agency has added several screenings, including Pap smears, mammograms, diabetes and colorectal cancer.

Report Details:

IVD Procedure Volume and Pricing Analysis
Published: January, 2013
Pages: 210
Price: US$ 3,995.00

However, there are many factors restraining this market. For example, the FDA and CMS are attempting to reorganize reimbursement and the regulation of IVDs and especially lab developed tests and molecular assays. Many tests are launched as RUO (research use only) and IUO (investigation use only), allowing manufacturers to gather information for eventual market clearance. In May 2011, the FDA issued draft guidance on this practice noting that it has led in some cases to diagnostic use of laboratory tests with unproven performance characteristics and manufacturing controls. Based on these draft guidelines, manufacturers who label their IVD products “RUO/IUO” should not sell such products to laboratories that they know use the product for clinical diagnostic use. If a manufacturer learns that a laboratory to which it sells its RUO/IUO-labeled IVD product is using it in clinical diagnosis, it should halt such sales or comply with FDA requirements for IVD products, including premarket review requirements, if applicable.

RUO/IUO reagents cannot be sold to laboratories that will be using them for development of their LDTs, (lab developed tests) the manufacturer of such labeled reagents cannot assist the laboratory in validation or verification of any LDT based on RUO/IUO labeled reagents.

More information can be found in the report “IVD Procedure Volume and Pricing Analysis” by Kalorama Information.

To order the report or ask for sample pages contact [email protected]


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