Verigene Test Kits

Notice of Intent to Sole Source

The Naval Medical Center San Diego (NMCSD) intends to award a sole source purchase order under the authority of FAR 13.106-1(b) (1) (i), due to only one source being available to meet the Government's needs, to

Nanosphere, Inc.
4088 Commercial Ave
Northbrook, IL, 60062-1829

The Naval Medical Center San Diego has a requirement for a purchase order for assays and consumables to be used for multiplex detection of respiratory viruses. The assays and consumables shall be compatible with the Nanosphere Verigene system that NMC San Diego currently owns. These essays shall be able to be used to perform multiple tests on an individual patient specimen simultaneously in a fully-automated random-access capacity that allows for an increased throughput while decreasing the demands on staff workload. The use of nucleic acid amplification and multiplex detection increased accuracy and precision not provided by other testing methodologies. These essays shall be able to detect viruses from swabs, aspirates and washes as well as sputum to detect at a minimum Influenza A, Influenza A subtypes H1 and H3, Influenza B, Respiratory Syncytial Virus, Adenovirus, Rhinovirus, Parainfluenza Viruses 1, 2, 3, and 4, Metapneumovirus and Bordetella pertussis. Specificity and differentiation of target detection is essential to aboid cross-reactivity and false reporting of results with a demonstrated specificity of at least 95% for each individual target included in the panel. Assay sensitivity should be sufficient to detect a range of viral titers that corresponds to very early infection, fulminant infection, and convalescing infections. Also provide testing for the identification of gram-positive and gram-negative bacteria in positive blood cultures.

The following items are needed:

Clin #           Catalog Number                       Description                       Qty
0001             20-005-024               Verigene RP Flex Test
                                                    Cartridges and Extraction Trays, 20/kit 45
0002             20-012-024               Verigene RP Flex
                                                     Amplification Trays, 20/kit                   45
0003 Shipping
0004-Option quantity
                     20-005-024               Verigene RP Flex Test
                                                     Cartridges and Extraction Trays, 20/kit 45
0005-Option quantity 
                     20-012-024                 Verigene RP Flex
                                                       Amplification Trays, 20/kit                   45
0006-Option quantity-Shipping

The objective of this sole source award is to procure Verigene RP Flex Test for the existing Nanosphere Verigene System. Due to warranty provisions and to avoid potential damage to the analyzer (and test results), only Verigene Test Kit from Nanosphere Inc. are to be used. Sole source is based on proprietary reasons in that Nanosphere Inc. is a sole proprietor of the Verigene test, the use of an unauthorized source for the assay may cause malfunction or damage to the Nanosphere system or cause inaccurate testing results. Due to the proprietary nature of this supplies, no other company was found that could provide the assay should a problem arise.

Delivery Day: March 2, 2017
The NAICS code for this requirement is 325413; the small business size standard is 1,250.

This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 7 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on 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 or to proceed with a sole source purchase order.

Capability statements are due by 10:00 AM Local Time, 24 February, 2017. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: uyen.t.tran6.civ@mail.mil. The email subject line shall state: "Naval Medical Center San Diego, Notice of Intent to Award Sole Source for Verigene Test Kits"

NO TELEPHONE REQUESTS WILL BE HONORED