RainDrop Digital PCR System

Trade Agreement: Agreement on Internal Trade (AIT) Tendering Procedures: Generally only one firm has been invited to bid Attachment: None Non-Competitive Procurement Strategy: Exclusive Rights Comprehensive Land Claim Agreement: No Vendor Name and Address: RainDance Technologies 44 Hartwell Avenue Lexington Massachusetts United States 02421 Nature of Requirements: Leanne Barenz Supply Specialist Telephone: 204 983-0506 E-mail: leanne.barenz@pwgsc-tpsgc.gc.ca File No.:5K003-131416/A

TITLE: RAINDROP DIGITAL PCR SYSTEM

Public Works and Government Services Canada (PWGSC), on behalf of the Canadian Grain Commission (CGC), intends to negotiate with RainDance Technologies for the provision of the following:

RainDrop Digital PCR System

The Microbiology Laboratory of the Canadian Grain Commission (CGC) has a requirement for the supply of one (1) RainDrop Digital PCR System to be delivered, FOB destination, to Winnipeg, Manitoba (Canada).

The microbiology program of the Grain Research Laboratory (GRL) monitors the presence of pathogenic fungi and bacteria on Canadian grains, as well as conducts tests to determine the impact of these organisms on the quality and safety of the grain. In support of the official statements of assurance and phytosanitary certificates for export shipments of Canadian grains issued by the CGC and the Canadian Food Inspection Agency (CFIA), our monitoring of wheat and other small cereal grains includes tests for quarantine microorganisms such as Tilletia indica (Karnal bunt), Tilletia controversa (Dwarf bunt) and Urocystis agropyri (Flag smut). This directly relates to CGC's mandate of ensuring the quality and safety of Canadian grains.

For bio-molecular detection of microbial pathogens on grain, mainly quantitative polymerase chain reaction (qPCR) assays are used in our laboratory. On a routine basis, quantification of genomic DNA of microbial pathogens is done on a large number of samples in a high-throughput manner using real time-PCR assays. In principle, by carrying out one reaction per single sample, results of traditional qPCR methods are generated as relative measures and are difficult to compare with data from other laboratories. In contrast, in digital PCR the sample is separated into a large number of partitions and the reaction is carried out in each partition individually. This separation allows a more reliable, statistically sound collection and sensitive measurement of absolute amounts of nucleic acid (DNA). Therefore, the microbiology lab of the GRL intends to use digital PCR for the standardization of single- and multiplex qPCR assays in-house. In addition, digital PCR has been demonstrated as useful for the detection and quantification of microbial pathogens that could be present at very low levels.

The microbiology lab of the GRL has a requirement for the provision of RainDance Technologies' digital PCR (Polymerase Chain Reaction) system 'RainDrop' that can conduct up to 10 bio-molecular tests on the same sample simultaneously using a closed-tube design - eliminating contamination or carryover of sample material that could lead to false positive results. With zero-tolerance quarantine regulations for small cereals contaminated with Tilletia controversa in China, Urocystis agropyri in Brazil, and Tilletia indica in at least 17 importing countries plus the entire European Union, traditional real time-PCR techniques are not suited for the level of sensitivity and reproducibility required.

In addition, a number of research projects also require DNA quantification capabilities that are both highly sensitive and absolute in nature (rather than relative). For example, studies on the microbial biomass using genomic DNA as a proxy are expected to be more accurate based on absolute amounts of target DNA. Also, risk estimation of microbial contaminants like bio-active secondary metabolites (mycotoxins) has the potential to be more rapid and less expensive using droplet-based digital PCR.

Required Functional Specifications

System must include a droplet generator that creates and collects droplets (in-oil emulsion) and a droplet reader that identifies and counts droplets following PCR amplification;

Detection channels for 2 colours: pre-calibrated for FAM (6-carboxyfluorescein) & VIC (proprietary fluorophore of Applied Biosystems) fluorophores;

Droplet generator and reader must each have a capacity to process at least eight (8) samples per run simultaneously;

Droplet-based digital PCR system must have a closed-tube design to avoid contamination and carryover of sample;

Multiplexing must be able to detect a minimum of eight (8) targets in one (1) reaction simultaneously;

PCR reactions in droplet-based digital PCR system must be able to utilize non-proprietary PCR reagents (master mix) to allow for changes/optimization in assay protocols;

Number of droplets/partitions must be at least 1,000,000, each with a volume of less than 10pl per droplet/partition;

Droplet-based digital PCR system must have a linear dynamic range of at least 5 orders of magnitude (with r²>0.99) for detection of input samples;

Droplet-based digital PCR system is compatible with TaqMan probe chemistry

Maximum throughput of droplet reader must be a minimum of eight (8) samples per hour with 25µl sample volume;

Maximum throughput of droplet generator must be at least 16 samples per hour;

Consumable costs per data point must be not more than $0.00005;

The equipment must be approved by the Canadian Standards Association (CSA) or an acceptable equivalent (UL) before shipping to the Canadian Grain Commission. CSA approval may be obtained by the CGC after acceptance as long as equivalent standard has been met and is appropriately labelled as certified on equipment.

Must be delivered on or before January 31, 2013.

The only digital droplet-based polymerase chain reaction technology system we are aware of that possess all of these abilities and meets these mandatory requirements is the RainDrop Digital PCR System from RainDance Technologies, 44 Hartwell Avenue, Lexington, MA., USA.

The following limited tendering reasons pertain to this requirement:

Government Contract Regulations, Part 1, Section 6(d) only one supplier (person or firm) is capable of performing the contract.

Government on Internal Trade (AIT), Article 506-12(b) where there is an absence of competition for technical reasons and the goods or services can be supplied only by a particular supplier and no alternative or substitute exists;

Estimated Cost: $105,000.00 - $110,000.00 (GST not included) Delivery Date: Above-mentioned

You are hereby notified that the government intends to negotiate with one firm only as identified above. Should you have any questions concerning this requirement, contact the contracting officer identified above.

An Advance Contract Award Notice (ACAN) allows departments and agencies to post a notice, for no less than fifteen (15) calendar days, indicating to the supplier community that it intends to award a good, service or construction contract to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the requirements set out in the ACAN, the contracting authority may then proceed with the award. However, should a Statement of Capabilities be found to meet the requirements set out in the ACAN, then the contracting authority will proceed to a full tendering process.

Suppliers who consider themselves fully qualified and available to provide the services/goods described herein, may submit a statement of capabilities in writing to the contact person identified in this Notice on or before the closing date of this Notice. The statement of capabilities must clearly demonstrate how the supplier meets the advertised requirements.

The PWGSC file number, the contracting officer's name and the closing date of the ACAN must appear on the outside of the envelope in block letters or, in the case of a facsimile transmission, on the covering page.

The Crown retains the right to negotiate with suppliers on any procurement.

Documents may be submitted in either official language of Canada.