SOW.doc

STATEMENT OF WORK

1.0

PURCHASE ORDER TITLE

The purpose of this acquisition is to purchase a Lionheart TM FX Automated Microscope with accessories.

2.0

BACKGROUND

There is only one drug that has been approved by the FDA for treatment of sickle cell disease. The drug is only partially successful, so there is an urgent need for addtional drugs. The Eaton group of 8 PhD scientists and one post-bac are working full time to discover an additional drug using a drug screen on sickle trait cells, the benign heterozygous condition. Any drug that inhibits with our current assay for trait will have to be measured in the (SS) blood from sickle cell patients.

3.0

OBJECTIVE

We urgently need a a seond Lionheat instrument to make measurements on SS blood under strictly physiological conditions as part of our new high thorughput screen of the 12,000 compound Gates/Calibr library to discover a drug to treat sickle cell disease. The Biotek Lionhart Automated Microscope System is perfectly suited for these measurements. The instrument will also be used for monitoring the sickling kinetics of SS patients on any candidate drug that we discover. A critical feature of the instrument is that the oxygen partial pressure is measured inside the chamber containing the well plate, a critical component for our measurements not available in any other instrument. There is no competing instrument that is suitable for measuring sickling times.

We are about to receive a precious library of 12,000 compounds contained in Gates/Scripps reFRAME library that have been clinically tested in humans. This library was constructed with the support of a grant from the Bill and Melinda Gates Foundation to California Biomedical Research, an affiliate of the Scripps Institute. The assay we shall employ for screening the 12,000 compounds of the library uses nitrogen deoxygenation in a 384 well-plate format with images of sickle trait cells measured for each well every 15 minutes.

The Lionheart has turned out to be absolutely ideal for performing this assay, in terms of both engineering, microscope optics, quality of images and software control of the data collection. Moreover, we have invested many months of software development to analyze the images from the Lionheart for the purposes of our assay. A second Lionheart will double the output, thereby tremendously accelerating our screen of these 12,000 compounds, reducing the first pass at a single concentration from 8 months to 4 months. A second instrument is also necessary to carry out a collaborative project on mice genetically modified to have sickle cell disease in collaboration with the Chief of the Sickle Cell Disease Branch, NHLBI.

4.0

TASKS AREAS

The Lionheart TM FX Automated Microscope will be set up and utilized in Building 5, NIH.

4.1 Task Area 1 – Delivery of Lionheart FX Automated Microscope Catalog

LFX within 90 days of award.

4.1.1 Included accessories at no additional cost:

4.1.1.A Imaging System Controller

4.1.1.B Advanced Assay Optimization Tier 2

4.1.1.C Field Warranty Upgrade/2

4.1.1.D Not for Human Invitro Diagnostic

4.2 Task Area 2 – Gen5 Image+ Software 4.3 Task Area 3 – Enviromental Control Cover 4.4 Task Area 4 – Humidity and Gas Control Chamber

4.5 Task Area 5 – CO2 and O2 Gas Controller

4.6 Task Area 6 – 10X Phase Objective

4.7 Task Area 7 – 20X Phase Objective

4.8 Task Area 8 – Laser Auto Focus

4.9 Task Area 9 – Service Basic Installation and Training, Tier 2

4.10 Task Area 10 – Shipping and Handling

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