The National Cancer Institute (NCI), Laboratory of Cell Biology (LCB), plans to procure on a sole source the brand name Applied Biosystems 7900HT Instrument, TaqMan® Low Density Arrays (TLDA) chips, reagents and robotics from Applied Biosystems Inc; 850 Lincoln Center Drive; Foster City, CA 94404

This acquisition will be conducted under the procedures for acquiring commercial items authorized in FAR Part 12 and under the authority to use simplified procedures for commercial requirements as provided in FAR 13.501.

The North American Industry Classification System code is 334516 and the business size standard is 500 employees. 

The Laboratory of Cell Biology is comprised of 9 sections each working together to unravel the mystery and decipher different aspects of what makes a cell cancerous and how we treat it. Success in treatment of some disseminated cancers with chemotherapy has led to intensified efforts to understand why many other cancers are intrinsically resistant to anticancer drugs or become resistant to chemotherapy after many rounds of treatment. Identifying genes and mechanisms critical to the development of multidrug resistance in vivo and establishing a reliable method for analyzing clinical samples could help to predict the development of resistance and lead to treatments designed to circumvent it.

The NCI initiated studies in September 2007 to assess mechanisms of intrinsic and acquired-drug resistance in ovarian cancer using a state-of-the-art customized high-throughput quantitative RT-PCR methodology known as the TaqMan® Low Density Arrays (TLDA) developed by Applied Biosystems Inc/ Applera. 

The salient characteristics of the RT-PCR Instrument are:

1. A Peltier-based system Thermal Cycling System is needed with a Low Density Array block
2. An instrument should be able to run compatible consumables such as 96-well plates, 384-well plates, and  Low Density Arrays
3. The sample ramp rate must be: +/-1.6°C/sec with the Peak Block Ramp Rate of 2.0°C/sec.
4. The required Temperature Accuracy +/-0.25°C (35°C to 95°C) of setpoint/display temperature, measured at 3 minutes after clock start while the Temperature Uniformity must be  +/-0.50°C, 30 seconds after clock start.
5. This instrument should have an optical System Extended-life 488 nm argon-ion laser excitation source with Excitation light distributed to all wells via a dual-axis synchronous scanning head.
6. The fluorescence detection must occur via spectrograph and CCD camera.
7. The calibrated Dyes at Installation should be: FAM™, VIC™, ROX™.

The salient characteristics of the TaqMan® Custom array are:

1. It is a 384-well micro fluidic card that enables a researcher to perform 384 simultaneous real-time PCR reactions without the need to use liquid-handling robots or multi-channel pipettors to fill the card.
2. The low- to medium- throughput micro fluidic card allows for 1-8 samples to be run in parallel against 12-384 TaqMan® Gene Expression Assay targets that are pre-loaded into each of the wells on the card.
3. It is completely customizable.
4. It has over 50,000 TaqMan® Gene Expression Assays designed for human, mouse, and rat genes can be loaded.

To perform the real-time PCR, the PCR kit must have:

1. Components needed for all 5' nuclease assays using TaqMan®-probe PCR applications. Employs AmpliTaq Gold® DNA polymerase for enhanced performance especially with G/C-rich sequences.
2. Contain AmpErase® UNG to protect against subsequent re-amplifications from PCR products containing dU to minimize carry-over contamination.
3. Have a passive Reference I to correct for inter-well signal variation caused by slight differences in the reaction volume.
4. Have a robotic automation accessory should be installed to the Real-Time PCR System. With the robotic automation over 5,000 sample wells per day with 384-well block configuration and standard thermal cycling protocol can be performed.

This microfluidic card requires a high capacity cDNA reverse transcription kit which can perform the quantitative conversion of up to 2 µg of total RNA in a single 20 µL reaction to single stranded cDNA. Reactions should also be able to be scaled up to 100 µL to generate 10 µg of cDNA from a single reaction. This kit should yields better performance than the market leading cDNA synthesis kits with 10-fold greater dynamic range.

The quantitative real-time TaqMan PCR technique has several advantages over other systems. The utilization of fluorescent dye-labeled probes increases the sensitivity of the system by at least 7 orders of magnitude and gives rise to a linear relationship between copy number and CT values. In addition, the liquid hybridization assay adds further specificity to the system, comparable to hybridization techniques using blotted PCR products.

PART II. Facts and Reasons To Justify Other than Full And Open Competition

1.         Statute: 13.106-1 (b)(2)

(b) Solicitation from a single source. 

(2)   For Sole source acquisition of commercial items in excess of the simplified acquisition threshold conducted pursuant to subpart 13.5, the requirements at 13.501(a) apply.

1. Sole Source Justification

This Applied Biosystems instrumentation is the only available source on the open market that provides the detection needed for our on-going collaborative multi drug resistance studies.  The reagents and instrument are licensed by Applied Biosystems so they cannot be used on any other platform. The reagents and TLDA chips are specific to only the Applied Biosystems 7900HT instrumentation. The NCI is purchasing the TLDA system to complete the studies initiated in 2007. This is  the only instrument, and the one that yielded far superior results in the NCI’s comparative methodology study is the Applied Biosystems 7900HT and TLDA chips.

There is no other company known to the NCI that produces such a micro-fluidic card that performs Taqman-based Real-time PCR in a high-throughput fashion. In addition, only the Applied Biosystems 7900 HT can be used to run these TLDA’s. No credible model explaining the mechanisms of multidrug resistance (MDR) has yet been demonstrated. In addition, no standardized diagnostic tool has been highly recommended or widely accepted for the purpose of deciphering the mechanisms of multidrug resistance.

This groundbreaking technology has the potential to substantially benefit both researchers and patients, with the goal of personalized treatment for those who suffer from cancer.

This is not a solicitation for competitive quotations.  However, if any interested party believes it can perform the requirement as detailed they may submit a statement of capabilities. All information furnished shall be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein.  An original and one copy of the capability statement must be received in the contracting office by 11:00 am EDT, on November 11, 2008.  All questions must be in writing and must be emailed to Karri Mares at [email protected] faxed to (301) 402-4513. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.  Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.  In order to receive an award from the NCI contractors must be registered in the Online Representations and Certifications Applications (ORCA).  Please refer to http://orca.bpn.gov    In addition; contractors must be registered in the Central Contractor Registration (CCR) www.ccr.gov. No collect calls will be accepted. Please reference NCI-90009-KM on all correspondence.