SOLICITATION NOTICE
A -- Blood Analyzers for Deep Space Missions
- Notice Date
- 8/22/2017
- Notice Type
- Presolicitation
- NAICS
- 334510
— Electromedical and Electrotherapeutic Apparatus Manufacturing
- Contracting Office
- NASA/Glenn Research Center, 21000 Brookpark Road, Cleveland, Ohio, 44135
- ZIP Code
- 44135
- Solicitation Number
- SHMSI0002
- Point of Contact
- Melissa A Merrill, Phone: 2164336359
- E-Mail Address
-
melissa.a.merrill@nasa.gov
(melissa.a.merrill@nasa.gov)
- Small Business Set-Aside
- N/A
- Description
- Blood Analyzers for Deep Space Missions (RFI) 1 General Information Request for Information Number: SHMSI0002 NAIS Posted Date: August 22, 2017 FedBizOpps Posted Date: August 22, 2017 Cutoff to Apply for On-site Visit: Not available at this time On-site Informational Visit Date: Not available at this time Deadline for Written Questions: September 1, 2017 Response Due Date: September 22, 201zers for Deep Space Missions Recovery and Reinvestment Act Action: No Classification Code: A - Research and Development NAICS Code: 334510, 339112 Set-Aside Code: N/A Issued by: NASA Glenn Research Center   Table of Contents 1 General Information 1 1 Synopsis 3 2 Background 3 2.1 Sample characteristics 3 2.2 Assay requirements 4 2.3 Platform requirements 5 3 General Information 5 4 Request for Information 6 4.1 General 7 4.2 Information Requested 7 4.2.1 Description of POC and consumables 7 4.2.2 Sample acquisition, pre-processing, processing and analysis 7 4.2.3 Assay capability 8 4.3 Instructions for Submittal 8 1 Synopsis NASA Glenn Research Center (GRC) is seeking information on existing point-of-care (POC) devices that are potential candidates for biomedical diagnostics during low-earth orbit (LEO) and deep space missions. Such missions are severely constrained in terms of available mass, volume, power, and storage of reagents (refrigerated or otherwise). POC systems that have been miniaturized and employ resource-conscious operation strategies are highly desirable, such as multiplexing, minimal use of reagents, minor waste generation, reusability of system components, and/or straightforward adaptation to accommodate other assays. For application to LEO, assays must remain viable for at least 1 year. For deep space, the timeline is extended further to a minimum of 3 years. 2 Background NASA would like to perform in situ blood and urine analysis on astronauts for routine monitoring and diagnosis of medical conditions. NASA has tested some commercial point-of-care devices on the International Space Station, but has generally determined that the most accurate measurements are made when astronaut blood and urine samples are transported back to earth for analysis in a ground-based laboratory. In order to perform real-time analysis of blood and urine, NASA requires a POC device that is self-sufficient, easy to use and reliable. To prepare for a return to deep space, a technology demonstration of human blood analysis on the International Space Station is envisioned to identify shortcomings or verify suitability of POCs for operation in a spacecraft environment. One or more POCs will be evaluated. It is expected that vibration and thermal testing of the candidate device(s) will start at the end of 2020 to verify flight readiness for a technology demonstration in 2021. Mission requirements for deep space impose severe constraints; the most pressing are minimal mass/volume/power availability and lack of a supply chain. A brief summary of requirements is given below. For further information, please see [1]. 2.1 Sample characteristics Sample types may be whole blood from a fingerstick or serum from a venous blood draw. For samples of capillary blood from fingersticks, it is undesirable to require more than 30 L of whole blood at a time. Samples may be pipetted from the blood source to the device, although a sample collection device that is integrated with the analysis system is preferable. For resource efficiency, it is also advantageous that the POC accept other sample types, such as human urine and saliva, fluids from animals and plants, and potable water. While this capability is not required for the technology demonstration, having such capability or a clearly defined path toward such capability, is highly desirable. 2.2 Assay requirements The essential assays that for blood diagnostics involve cytometry and standard blood tests, as follows: 1. Sodium 2. Potassium 3. Creatinine 4. Glucose 5. White blood cell count 6. Hemoglobin and/or hematocrit 7. Platelet count 8. Neutrophil count 9. Lymphocyte count 10. Complete blood count (CBC) with differential 11. Alanine aminotransferase (ALT) 12. Alkanine phosphatase (ALP) 13. Aspartate aminotransferase (AST) 14. Blood urea nitrogen (BUN) 15. Troponin 16. Lactate 17. Total bilirubin 18. Direct bilirubin 19. Lipase 20. Venous blood gases (VBG) 21. Creatinine kinase 22. Prothrombin time (PT) 23. Partial thromboplastin time (PTT) Commonly used standard ranges should be accommodated by the POC. Many other assays are also of interest, particularly those involved in assessing immune function, nutrition, and bone health. Assays for identifying substance abuse are not of interest for this application. FDA-approved assays are not required for this RFI, but Respondent should have an interest in achieving such certification and have processes in place to advance the assay toward 510(k) certification. If not FDA-approved, specify assay maturity, e.g., level of validation. While it is not necessary for a POC to perform all of the above assays, devices with more capabilities are preferred. If any of the above assays are not currently available, but could be with additional work, please note the current level of maturity in the response. If the responder has no interest in developing any of the above assays, that should also be noted. Given the target environment, simultaneous measurements of the above analytes is highly desirable. 2.3 Platform requirements The requirements for the point-of-care device and its consumables are as follows: • Size: While a handheld-sized POC is highly desirable, larger systems such as a benchtop-scale device will also be considered. • Power: Battery-powered, USB-powered or wall outlet powered will be acceptable for the technology demonstration. • Data requirements. The POC reader may be a standalone device or it may use a laptop or Smartphone for processing, storing and displaying data, if desired. If a laptop is needed, it does not need to count against overall system size. A means of clearly displaying assay results is required. Both raw and processed data should be stored and available for retrieval, as needed. • Software: Any software packages that are used for analysis should be identified, such as MATLAB, LabView or proprietary software. • Human interaction. The crew will be trained to use the device but should not be considered medical professionals. Therefore, the POC must be autonomous and easy to use. • Communications: Devices must have developed the means of transmitting raw and processed data to onboard computers. Wireless communications are preferred, but wired communications are permissible. • Shelf life: At least 1 year for the technology demonstration on ISS. At least 3 years for a deep space mission. If any component of the assay system has not yet achieved a 3-year shelf life, a brief description of a reasonable path of technology development that would achieve this requirement is requested. • Storage: Some storage at ambient conditions is available, but refrigerated storage is not possible. • Supporting equipment: If the POC requires supporting equipment, e.g., for pre-processing, processing, and/or analysis stages, Respondents must specify and describe such equipment. 3 General Information This RFI is used solely for information planning purposes and does not constitute a solicitation. In accordance with FAR 15.201(e), responses to this RFI are not offers and cannot be accepted by NASA to form a binding contract. NASA is under no obligation to issue a solicitation or to award any contract based on this RFI. The information provided in response to this RFI will not be made public so as to protect any propriety company information. Nonetheless, Respondents should clearly and properly mark any propriety or restricted data contained within its submission so it can be identified and protected. Respondents are solely responsible for all expenses associated with responding to this RFI. Responses to this RFI will not be returned, and Respondents will not be notified of the result of the review. All requirements identified herein are tentative and will be finalized prior to the release of any solicitation for proposals. The government does not intend to award a contract on the basis of this RFI or to otherwise pay for the information solicited. The information provided is entirely voluntary and will not affect the ability to bid on future requirements. This RFI is for planning purposes only and shall not be considered as an obligation on the part of the Government to acquire any products or services. No solicitation exists; therefore, do not request a copy of a solicitation. If a solicitation is released it will be synopsized in FedBizOpps and on the NASA Acquisition Internet Service. It is the potential Respondent's responsibility to monitor these sites for the release of any solicitation or synopsis. NASA may utilize the information provided in developing its acquisition strategy. The information resulting from this RFI may be included in one or more solicitations. Respondents are encouraged to provide information that is not constrained by limited/restricted data rights. However, if proprietary data is included in a reply, it is to be marked appropriately. NASA intends to evaluate all data received for potential go-forward options and plans. Please note, NASA, other interested Government agencies, federally funded research and development centers (FFRDCs), as well as support contractors and/or their sub-contractors working on behalf of the Government will be reviewing the information. Potential Respondents should only submit information that can be made available to those parties and should note that by submitting information to this request, the above parties will be able to review each Respondent's information. For the purposes of this RFI, an Engineering Cost Estimate (ECE) is defined as a high-level single estimate without line item breakouts or rates that provides an educated financial estimate, to be reported in FY17 dollars. Similarly, a Planning Schedule Estimate (PSE) is a single schedule task bar or duration estimate in calendar days, weeks, or months without any lower level itemized task detail. Programmatic related questions should be directed to: Sam.W.Hussey@nasa.gov Technical questions should be directed to: Emily.S.Nelson@nasa.gov Interested Respondents should submit all questions in writing no later than September 01, 2017 so that answers may (at the Governments discretion) be posted as an amendment to the RFI. 4 Request for Information Information is requested from potential suppliers to gauge readiness of point-of-care devices for use in space medicine for a technology demonstration on the International Space Station, currently envisioned for the end of 2021. 4.1 General NASA GRC is seeking information on existing POC devices and assays that have been validated on the platform. Devices must have a means of transmitting raw and processed data to onboard computers. 4.2 Information Requested Below are the specific data that should be included in the Response. If desired capabilities in the POC, consumables, or assay suite are not currently available, but the Respondent has an interest in developing such capabilities, please provide a brief Engineering Cost Estimate and Planning Schedule Estimate as described in Section 3. 4.2.1 Description of POC and consumables Respondents should address the following items on this topic, at a minimum: • General information. Weight and dimensions of platform and consumables, platform power requirements, communications capabilities. Specify any supporting equipment that is needed, e.g., for extraction or sample filtration. Identify the materials used in any consumables, particularly plastics that may be recovered for other purposes. Identify and describe any hazardous materials or processes that are necessary for device operation. Specify the need for more than one device, if needed to provide assay breadth as described in Section 2.2. • Detection modality or modalities. Describe measurement methods used to quantify assays of mutual interest. • Capability and maturity of multiplexing, e.g., 3 fully developed assays for Assay1, Assay2 and Assay3 have been validated in the lab in a multiplexed mode of operation. • Communications capabilities. Specific information on wireless/wired communications protocols are requested. • Status of FDA readiness. Indicate whether or not the device is compliant with ISO13485, registered with the FDA as a medical device, and/or approved for use for research and/or diagnostic purposes. • Use history. Describe how the device has been used, e.g., commercial or laboratory operations, length of time (or other descriptor of device application) that the device has been in use, customer base. • Ease of use. Describe the operation of the device from sample acquisition to the display of results and any efforts that have been made to verify ease of use by minimally trained operators. 4.2.2 Sample acquisition, pre-processing, processing and analysis Respondents should address the following items on this topic, at a minimum: • Sample types currently accepted by the device. Of particular interest to this RFI are capabilities for operation on whole blood. If desired, include feasibility of including other sample types and briefly describe required additional technology development. Of interest are fluids from humans, animals, plants, cell cultures, and potable water. • Sample acquisition strategy. If a specialized device for sample acquisition has been developed, describe its design and function. Describe process of sample introduction. • Sample pre-processing/processing protocols. Describe features of sample processing and analysis, including filtration, mixing, metering, incubation, lysing, reagent usage, need for buffer solution, etc. Identify whether or not any supporting equipment is required for any of these stages. • Sample analysis protocols. Describe software/hardware used for sample analysis, detection modality, results display. 4.2.3 Assay capability NASA is interested in POCs with broad assay capability and potential for adding new assays to the currently available suite. Please provide any information on other partners who would be willing to absorb some of the cost of assay development. Respondents should address the following items on this topic, at a minimum: • Assay breadth. Identify assays for which feasibility or better have been achieved. For each assay, describe: o Assay quality. Identify sensitivity, specificity, precision, accuracy, repeatability, limits of detection. o Assay maturity and validation. Describe level of validation, e.g., blind testing in the laboratory on simulated samples, clinical samples, commercially obtained samples of known composition, independent testing by laboratory or other entity, comparisons against gold standards, number of subjects in clinical studies o FDA approvals or readiness. If assay is not FDA-approved, please provide an ESE and PSE as described in Section 3 for achieving this status. o Use history. o Shelf life. A 1-year shelf life at minimum is required for the Technology Demonstration and a 3-year shelf life at minimum is required for deep space missions. If assay has not achieved these goals and Respondent has an interest in improving shelf life, please include an ESE and PSE as defined in Section 3. • Feasibility of measuring NASA's operational analytes, i.e., the assay suite described in section 2.2. 4.3 Instructions for Submittal Responses should be limited to the information requested in Table 1 below. Table 1. Information Volumes Requested Volume I Executive Summary 1 electronic copy, 10 maximum MS PowerPoint charts (or equiv. Adobe.pdf format) Volume II RFI response to information requested in sections 4.1 and 4.2 1 electronic copy 30 single sided pages maximum MS Word pages (or equiv. Adobe.pdf format) Responses to this RFI shall be submitted in writing and electronic media postmarked no later than 5:00 PM EST on September 22, 2017. Responses must be submitted to: Melissa Merrill, Contracting Officer Glenn Research Center MS 60-1 21000 Brookpark Road Cleveland, Ohio 44135 Melissa.a.merrill@nasa.gov The response must be sent as one printed hardcopy, and also electronically as a single Microsoft Word.docx (or equivalent Adobe Reader.pdf format) and/or Microsoft Excel.xlsx file, for each response burned on a CD or DVD. Acceptable file types are Microsoft Office Word 2010/2013 and Microsoft Office Excel 2010/2013, or equivalent Adobe Reader.pdf format. Please use 12-point Times New Roman font as well as single spaced pages printed one-sided. Concise information that specifically addresses the questions is requested. Examples, artifacts and quantitative data that fully respond to each sub-topic is requested. Please do not include corporate standard marketing factsheets, glossy material, or data. Potential Respondents are welcome to include links to studies, white papers, and other outside information via citation which provides a more complete response. Note that this information will NOT be counted towards the final page limitation.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/NASA/GRC/OPDC20220/SHMSI0002/listing.html)
- Place of Performance
- Address: TBD, United States
- Record
- SN04641767-W 20170824/170822233212-1061a5bfde2f82e8f74c6e72837a63ce (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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