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Application Questions
How do I apply to have my company’s assay considered for the Vanguard study and when are the applications due?
Email NCIMCED@mail.nih.gov no later than Friday, June 2, 2023, to request an application and a confidentiality agreement (if needed) from NCI. Applications are due Friday, June 9, 2023. NCI will confirm receipt of your application and materials within one business day. For more details on the application process, view the “Application Instructions for Assay Developers” box on the NCI MCD website or view slides 34-36 from the NCI Framework presentation (PDF, 4.97 MB).
Is CLIA certification a requirement for this application?
No. CLIA certification is not required for this application or to participate in the verification process by using Alliance Reference set specimens. However, CLIA certification is required for participation in the Vanguard study that launches in 2024. Evaluation by NCI of MCD developers’ plans for obtaining CLIA certification will be part of the selection process for the Vanguard study.
Are international companies eligible to participate?
Yes. International companies are eligible to apply. However, it would be challenging for NCI to have specimens shipped abroad. At this point, NCI will consider an application from an international company on a case-by-case basis.
If my company participated in the Request for Information (RFI), do we need to submit an application if we want to participate in the Vanguard study?
Thank you for your response to the RFI. Yes, if you wish to have your assay considered for the Vanguard study, you will need to submit an application.
May academic laboratories apply?
NCI welcomes applications from academic laboratories. NCI has a long history of collaborations with academic laboratories.
Can an assay developer submit more than one assay to be considered for selection in the Vanguard study? If yes, is more than one application required?
Yes. An assay developer may submit more than one application. Each assay will require its own application.
If my company already has a standing confidentiality agreement, are we required to make a new confidentiality agreement for this application?
No. You are not required to establish a new confidentiality agreement. However, you may request to extend your current confidentiality agreement depending on when your agreement expires.
What is the timeline for completing the steps to participate in the Vanguard study such as application due dates for assay developers, shipping of verification samples, and final assay selection?
Applications for assay consideration are due Friday, June 9, 2023. Applications will be reviewed, and material transfer agreements will be put in place with selected assay developers in the summer of 2023. The Alliance specimens will be sent to assay developers in the fall of 2023. NCI anticipates selecting the two assays for the Vanguard study and beginning contractual negotiations with assay developers by early 2024.
In January 2024, when the Cancer Screening Research Network (CSRN) is funded, protocol writing for the Vanguard study will begin. NCI anticipates starting recruitment for the Vanguard study in mid-2024.
What does NCI recommend assay developers do if they are not ready to participate in the Vanguard study, but think they will have a viable assay ready within the next four years?
Please still apply and explain your level of readiness in your application. NCI will strive to keep interested assay developers aware of future studies.
Assay Requirements
What is the minimum number of cancers an assay needs to be able to detect to be considered an MCD assay?
NCI has not set a minimum number of types of cancers an assay needs to be able to detect. However, NCI prefers assays that detect more than one cancer and preferably at least three cancers. There may be other opportunities for assays that detect 1-2 cancers within the Cancer Screening Research Network (CSRN). NCI encourages such developers to submit an application or contact NCI at NCIMCED@mail.nih.gov.
Is tissue of origin (TOO) prediction a requirement for an MCD assay?
No. TOO prediction is not a requirement.
Some assay developers may update their assays between NCI studies (Alliance Reference set, Vanguard, and Randomized Controlled Trial). How will this be addressed?
The assays should be locked down for the duration of any one study. If your assay changes from one study to another, NCI will seek to understand those changes.
Specimen Collection and Alliance Reference Set
How many samples would a company expect to receive for testing? Will those samples be made up of cases and controls?
The number of samples an assay developer receives will depend on the number of cancer types the assay detects. Samples will be blinded and contain both cases and controls with cases generally determined based on the assay’s targeted cancer types. An assay developer may anticipate receiving roughly between 500 and 1500 samples.
If I am concerned that the Alliance specimens may not be compatible with my company’s assay, should I still apply?
Yes. Please still apply. NCI recognizes that the Alliance specimens and collection methods may not be optimal for all assays. NCI will work with you during the application process to try to find reasonable alternatives.
Will all assay developers applying for the Vanguard study receive samples from the Alliance Reference set to assess their assay’s performance?
No, not necessarily. Applications will be assessed, and specimens will be prioritized for assay developers based on their readiness to participate in the Vanguard study.
Data Sharing
How will NCI handle data sharing and data use with selected MCD assay developers?
NCI plans to follow the Final NIH Policy for Data Management and Sharing for applicable data. Assay developers may contact NCI about additional data sharing expectations on a case-by-case basis.
General
My company is interested in gaining FDA approval. Has FDA provided any input into these planned studies?
FDA is offering non-binding input on the study protocols. FDA does not have a role in selecting the companies or determining the quality of the assays. Companies interested in marketing their MCD assays are encouraged to reach out early in the process directly to FDA via the Q-Submission process.