Optimization charges for IHC

• Optimizations for non-Ventana reagents have no predictable outcome or turnaround time. These require prior arrangements and are only performed under specific circumstances. The Lab emphasizes optimization of antibodies for use on the Ventana Ultra platform.
• The first round of optimization with a user provided antibody and positive controls has a one-time set-up charge plus a run charge based on the number of slides. Subsequent optimization runs for the same antibody are charged at the established run charge. The Lab reserves the right to terminate the optimization effort if the initial optimization matrices do not suggest that a usable assay will result.
• Initial optimization charges may be waived for Ventana antibodies that have been previously verified on the Ventana Ultra platform by the Barnes-Jewish Hospital Lab or WU Dermatopathology Center. It is the responsibility of the investigator to provide a copy of the protocol.
• In some situations, a User Antibody may have been characterized prior to conversion to the current testing platform in 2012. In this situation, it is usually necessary to submit a new optimization order.
• The implementation of a new double immunostaining assay for the automated platform using previously optimized antibodies usually requires additional optimization  because only a single retrieval condition can be used for both reagents. The usual one-time set-up and charges are billed, with subsequent runs charged as above. If two unoptimized antibodies are used, then the initial set-up charge is triple the usual rate.

Routine run charges for IHC

• Run charges are calculated on a per slide basis, as a base charge plus the cost of antibody (see price listing below). The base charge includes overhead for the equipment, bulk reagents, and technical time. Ventana reagents predictably increase by 3% per year. Costs for sectioning paraffin blocks are charged separately according to the histology price listing.
• The investigator covers the costs of antibody for their experiments.  If the Core has an active protocol, the investigator is charged for the actual amount of antibody used on each slide.  This per slide pricing is provided by Ventana for their pre-diluted antibodies (see Ventana price listing below).
• For previously optimized non-Ventana antibodies, it is advisable to examine representative test samples before beginning a new project, particularly if starting with a new lot of antibody.  Such slides will be charged like test slides.
• If the Core does not have an active protocol the investigator must cover the full cost for the purchase of the antibody. However, adjustments may be made if there are already plans to add the antibody to the clinical test menu and it can be predicted that the antibody will be sufficiently utilized prior to the expiration date. If stored by the Core, unused antibody will not be used for other projects without the investigator’s permission. However, no antibody will be held in the Core beyond its expiration date; expired reagents are discarded as soon as they are identified.
• If an antibody is purchased by the investigator or if the lab buys it on behalf of the investigator (i.e., the purchase of antibody is billed to investigators account) there will be no additional per slide antibody charge. However, if the antibody is to be used on the Ventana, the investigator will be charged for any registered dispensers (prep kits) or non-standard ancillary reagents.
• The pricing structure for positive and negative control slides is the same as described for test slides. The cost reflects the actual cost of control immunoglobulins and other reagents. At least one suitable positive control is required for every research run and there are a maximum of 30 slides per run.
• There is no charge when immunostaining is repeated because of a lab error.  The Core will also absorb the costs for cutting of additional sections and for loss of primary antibody. The Lab assumes no responsibility for failed testing if non-approved charged slides are provided or if the investigator opts out of recommended preliminary testing or re-validation.

Clinical trials

• Price estimates for grant applications will be calculated based on the best estimate of costs for the anticipated funding period. The cost for Ventana antibodies and reagents alone predictably increase by 3% per year.
• Pricing will be adjusted to include a costs for administering the workflow within the Lab. Depending on the complexity of a planned study initial set-up charges could also apply.
• A price estimate is only applicable to the project listed on the estimate; a new estimate is required for each project and for any change in the scope of work for an existing project.
• The Lab can only support testing that utilizes established, approved clinical workflows, i.e., validated tests performed using the approved clinical protocols and platforms.
• The Lab does not have resources to assume responsibility for any activities upstream or downstream of the Lab. Specimen transport and other activities are handled by the clinical trial coordinator or administrator under supervision of the investigator or via interactions with the Tissue Repository.
• The investigator is responsible for identifying study pathologists and insuring that all professional effort is funded via the grant, contract, or other mechanisms. AMP Labs price estimates do not include professional services, such as test interpretation, or technical services provided by other facilities, such as the Digital Imaging Center.
• Pricing for clinical trials may require prior review by the Pathology and Immunology Business Office.  Depending on the project, additional departmental or institutional fees may apply.
• Consultation regarding feasibility should be initiated as soon as possible, and financial and other arrangements must be completed well in advance of grant submission and anticipated start date.