Brand_Name_Justification-.pdf

MCMR-AAA-MA

SUBJECT: Sole Source Justifications (SSJ) BRAND NAME ONLY

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ENCLOSURE 1

Control No: JA17220

Sole Source Justification (SSJ) in accordance with FAR subparts 13.106 or 13.5 using Simplified

Acquisitions Procedures (SAP)

1. Contracting Activity: Director of Contracting, U.S. Army Medical Research Acquisition Activity (USAMRAA). 820 Chandler Street, Fort Detrick, MD 21702-5014.

2. Requiring Activity: The Armed Forces Medical Examiner System (AFMES), Armed Forces DNA Identification Laboratory (AFDIL). 115 Purple Heart Drive, Dover AFB, DE. 19902.

3. Nature of Action:

Commercial Item Non-Commercial Item New Requirement Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price* Time & Materials** Cost*

* See FAR 12.207(a) ** See FAR 12.207(b).

For Hybrid Contracts, list percentage of each type of pricing:

* Firm Fixed Price: ________

**Time & Materials: ________

* Cost: ________

Funds: RDT&E Operations and Maintenance, Army (OMA)

Other Funds:

Fiscal Year of Funds: FY17

Estimated Total Dollar Value including Options: $ 1,000,000.00

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4. Contractor Name:

Name of Proposed Contractor: Edge Biosystems, Inc.

Street Address: 201 Perry Pkwy STE 5 City, State, Zip: Gaithersburg, MD 20877-2140 Phone: 301-990-2685

DUNS: 609915020

Cage Code: 1PCJ9

5. Description of Supplies/Services:

The AFDIL requires reagents and supplies that provide optimal performance for the purification and filtration of dye terminators in sequencing chemistry (a necessary procedure used in DNA identification). In order to accomplish the proper purification and filtration, it is necessary to utilize a 96-well plate system, consisting of plates with columns in a standardized array, packed with a gel matrix optimized to effectively remove dye terminators, dNTPs, salts and other low molecular weight materials from sequencing reactions. During proof of concept and development of the methods for amplification and sequencing strategies, the DTR (Dye Terminator Removal) Ultra 96-Well Plates (manufactured by EDGE Biosystems Inc.) were proven by the government to be: reproducible from lot to lot; robust; reliable; and free from human nuclear and mitochondrial DNA contamination. Vendors that produce contamination free, reproducible and reliable reagents are essential for processing forensic casework samples and meeting AFDIL mission requirements. Development and optimization of the amplification and sequencing methodologies to identify missing individuals were performed using the Performa DTR Ultra 96- Well Plates and the Armed Forces DNA Identification Laboratory (AFDIL) requires sustained ability to purchase these plates for ongoing mission requirements in assisting the Armed Forces Medical Examiner System (AFMES) and the Defense POW/MIA Accounting Agency (DPAA) with DNA testing for the identification of U.S. Service members as mandated under title 10 USC, chapter 75, 1471 and 10 USC, Chapter 76, 1501-1513; NDAA 2010, Section 541 (d)(2) and DODI 5154.30.. The Performa DTR Ultra 96-Well Plates remove DNA primers and fragments up to 15 bases, buffers, and nucleotides labeled with biotin, isotopes and other assorted markers. Furthermore, the plates are pre-packed with a fully hydrated matrix to afford optimal handling and performance characteristics. To minimize the potential for interference with sequencing applications, no preservatives, salts or buffers are used in the preparation of these columns. Both ends of the plates are sealed to prevent drying and they require no refrigeration for storage. The plates have been validated and are compatible with Genetic Analyzers manufactured by Applied Biosystems (AB). The AFDIL uses 16 of these specialized Genetic Analyzers. The samples are spun through the plates and directly into the AB PRISM® MicroAmp® Optical 96 Well Reaction Plate used for capillary electrophoresis on the AB 3500xl Genetic Analyzer, the AB 3730 Genetic Analyzer, and the AB 3130xl Genetic Analyzer thereby saving a transfer step and reducing potential contamination and/or sample switching.

6. Authority Cited: 41 U.S.C. 1901 OR 41 U.S.C. 1903

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

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(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name);

OR

(d) FAR 13.501(a)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited: The suggested source for this requirement is Edge Biosystems, Inc. Edge Biosystems is the sole manufacturer of the DTR Ultra 96-well Plates. As there may be authorized resellers for these plates, it is desired that this procurement be BRAND NAME

ONLY.

a. Previously, EDGE Biosystems Inc. DTR (Dye Terminator Removal) Ultra 96-Well Plates was verified by the government to be reproducible, robust and free from human mitochondrial and nuclear DNA contamination. Vendor’s that produce contamination free, reproducible and reliable reagents are essential for use with these challenging samples and to meet AFDIL’s mission requirements. AFDIL completed the forensic validation of their amplification and sequencing strategies with the EDGE Biosystems Inc. DTR (Dye Terminator Removal) Ultra 96- Well Plates. The validation experiments were done in accordance with the Federal Bureau of Investigations Quality Assurance and the International Standards Organization (ISO) 17025 DNA forensic laboratory standards. Alterations to any reagent or kit that has been validated for use with this amplification and sequencing method will prevent the identification of missing individuals for at least 24-36 months, while new developmental testing and validations are performed to replace the EDGE Biosystems Inc. DTR (Dye Terminator Removal) Ultra 96-Well Plates. The need to first verify that alternative plates do not affect the reproducibility, reliability or increase the chance for contamination and then forensically revalidate the amplification and sequencing method will cost the government a significant amount of money to include two full time CME’s and undetermined amount in reagents and consumables.

b. The AFDIL core missions are to assist the Armed Forces Medical Examiner System (AFMES) with recent death investigations of military and civilian personnel lost in training mishaps, conflicts, and war; and the Defense POW/MIA Accounting Agency (DPAA) with past accounting of military and civilian personnel lost during World War II, the Korean War, Viet Nam and the Cold War. The use of the EDGE DTR plate to purify sequence samples has allowed AFDIL to establish a high throughput sequencing process that allows for more than 8,000 sequencing reactions per month to be performed. These plates have substantially increased AFDIL’s support of the past accounting mission and are needed so AFDIL can continue to support the AFMES and DPAA.

c. The AFDIL is an American Society of Crime Laboratory Directors (ASCLD) accredited forensic lab that provides mission essential services for a number of Agencies, including the Federal Bureau of Investigation (FBI), National Institute of Standards and Technology (NIST), the United States Army Criminal Investigations Laboratory (USACIL) and DoD agencies.

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AFDIL is a global leader who provides leadership in consultation, education, and research in the fields of human identification, forensic analytical services, bioinformatics, and human reference specimen collection. These reagents are needed to augment current identification methods and will increase the knowledge and success rates of the forensic community as a whole.

8. Efforts to obtain Competition: This requirement will be posted via FBO, unrestricted, BRAND NAME ONLY for 30 days. We are soliciting this Brand Name only, as there are other sources capable of providing the plates that have been previously validated for use by AFDIL.

Given the nature of the mission and the need to ensure consistency and validity of the DNA test results. EDGE Biosystems Inc. DTR (Dye Terminator Removal) Ultra 96-Well Plates were previously tested against other systems and these plates generated results that were reproducible, robust and free from human mitochondrial and nuclear DNA contamination when compared to competitor’s kits. Development validation and implementation of customized kits for the identification of deceased and/or missing military individuals has been completed; alternative competitors’ kits would significantly delay the use of this procedure and cost the government additional money as the laboratory would be required to pretest and re-optimize the method with different chemicals.

a. Effective competition. No effective competition is anticipated.

b. Subcontracting competition. Not Applicable: There is only one source capable of performing the required service.

9. Actions to remove or overcome barriers Competition: None. Because of the nature of the work performed at AFDIL, using any other brand or substitute consumable would compromise the validity of future tests. Edge Biosystems, Inc. is the only company that provides this consumable.

10. Market Survey: Prior to the decision to implement a product into the laboratory at AFDIL, extensive validation studies are performed to determine which product possesses the desired properties. Reagents and consumables are compared and tested for sensitivity, ease of use, consistency, cost, and compatibility with the existing instrumentation used in the laboratory.

Although similar products are on the market, they do not provide the same benefits from the recommended products that incorporate our current validated sequencing procedures with the Applied Biosystems 3730, 3130xl and 3500xl Genetic Analyzers. For example, the Millipore Montage 96-well plate is an ultra-filtration plate which requires vacuum filtration rather than centrifugation. Due to this, the results are uneven and inconsistent, and there is no complete elimination of unincorporated dyes. Another example is the Princeton Separations Centri-Sep 96-well plate. The plate contains a preservative. It also needs to equilibrate at room temperature for a couple of hours, and therefore prolongs the procedure. Lastly, the Agentcourt CleanSeq is based on magnetic beads, a completely different technology from what AFDIL uses. The CleanSeq is usually optimized on a robotic platform, and requires extensive optimization efforts.

In addition, we would have to buy another machine and change protocols to use this product.

Two of the compared sources are large businesses. Our recommended source is locally owned and operated Small Business. Based on past performance, they have continually been extremely responsive to our reagent and supply needs.

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11. Interested Sources: This requirement will be posted via FBO, unrestricted, BRAND NAME ONLY for 30 days.

12. Procurement History and any other facts:

Previous Contract or Purchase Order Number:

1. W81XWH-09-A-0011 Edge Biosystems, Inc.

2. W81XWH-11-D-0044

Previously competed? May 2011

Previous authority for less than Full & Open Competition: N/A

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13. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this SSJ are accurate and complete to the best of my knowledge and belief.

Submitted by Signature:

Printed name: Shairose Lalani Agency/Position/Title: DNA Program Specialist E-Mail Address: Shairose.a.lalani.civ@mail.mil Date: 10 July 2017 mailto:Shairose.a.lalani.civ@mail.mil

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14. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. Based upon the facts described herein, I hereby determine that the anticipated price/ cost to the Government will be fair and reasonable, and a determination of price reasonableness will be documented and placed in the contract file.

Contracting Officer Signature:

Printed name: Patrick K. Harris Agency/Position/Title: Contracting Officer E-Mail Address: patrick.k.harris11.civ@mail.mil Date: 10 July 2017 mailto:patrick.k.harris11.civ@mail.mil

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15. I hereby determine this SSJ to be Legally Sufficient.

Typed Name: Diana J. Esposito Date: _________________

Title: Attorney Advisor Signature: __________________________

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Approval

Based on the foregoing justification, I hereby approve the procurement of DTR Ultra Plates on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 or 41 U.S.C. 1903, as implemented by FAR subpart 13.106-1(b)(1) or FAR 13.501(a)(1)(ii), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Date: ___________________ Signature: ___________________________________ Christopher E. Sherman Special Competition Advocate