Opportunity Information: Apply for RFA FD 17 006
The Food and Drug Administration (FDA) funding opportunity titled Developing Biomarkers for Trastuzumab-induced Cardiotoxicity (RFA-FD-17-006) is a discretionary grant designed to support a single clinical-site research project focused on identifying and validating a potential blood-based biomarker for heart damage related to trastuzumab treatment. Trastuzumab is a widely used therapy, particularly in HER2-positive breast cancer, but it can cause cardiotoxicity in some patients. The goal of this award is to help researchers develop an early warning signal for cardiac injury so clinicians can detect risk sooner and potentially adjust monitoring or treatment before significant heart dysfunction occurs.
The project is built around a specific candidate biomarker, cMLC-1 (cardiac myosin light chain 1), which the study will evaluate as an early predictor of trastuzumab-associated cardiotoxicity. The work plan has two main scientific components. First, the award supports establishing and implementing a quantitative assay capable of measuring cMLC-1 levels in human samples. This is essentially the method development and validation step needed before the biomarker can be tested reliably in a clinical context. Second, the award supports a pilot clinical investigation to determine whether cMLC-1 levels rise earlier in patients who eventually develop cardiotoxicity compared with those who do not. The pilot comparison is intentionally small and targeted: cMLC-1 levels will be compared between two matched groups, five patients who later developed cardiotoxicity and five patients who did not, with matching specifically done by age to reduce one important source of confounding.
Cardiotoxicity in this study is defined using the Cardiac Review and Evaluation Committee for Trastuzumab (CREC) criteria, which anchors the outcome in an established and widely recognized clinical standard. Under the CREC definition used here, a patient is considered to have cardiotoxicity if the echocardiographic left ventricular ejection fraction (LVEF) drops by more than 10 percentage points to a value below 55. This definition matters because it ties the biomarker evaluation to a concrete, clinically meaningful change in cardiac function rather than a vague or subjective endpoint. The monitoring schedule described in the opportunity is also specific: women in the underlying cohort were monitored every three months for a total of 15 months, creating repeated time points that can be used to see whether cMLC-1 changes precede the detectable LVEF decline.
A key feature of the opportunity is the use of archived plasma samples collected at multiple time points over the monitoring period. Rather than requiring a brand-new sample collection effort, the study leverages existing stored specimens from patients who were followed longitudinally. Those archived plasma samples will be tested for cMLC-1 and also for troponin I. Troponin I is included as a comparator or control marker because it is a well-established indicator of heart muscle injury. By measuring troponin I alongside cMLC-1, the study can contextualize whether cMLC-1 provides added value, behaves differently over time, or potentially signals risk earlier than traditional cardiac injury markers in the specific setting of trastuzumab exposure.
In practical terms, the FDA is looking to fund a site that already has the clinical capability, patient access, and the appropriate sample resources to run this kind of biomarker-focused pilot work. The emphasis on a clinical site with patient samples suggests the award is meant to move quickly into real human data rather than spending most of the budget on early exploratory discovery. The expected output is not a definitive validation suitable for immediate broad clinical adoption, but rather a strong early signal about whether cMLC-1 is promising enough to justify larger studies, additional assay standardization, and eventual qualification efforts for use in drug safety monitoring contexts.
On the administrative side, the opportunity was issued by the FDA under CFDA number 93.103. The funding instrument is a grant, with an award ceiling of $140,000 and an expected number of awards of one. The opportunity was created on 2017-05-23 and had an original closing date of 2017-07-24.
Eligibility is broad across U.S.-based organization types, reflecting the FDA’s interest in enabling the most capable site to conduct the work regardless of sector. Eligible applicants include public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit entities including small businesses, and multiple levels of government entities (state, county, city/township, special districts, and certain tribal governments), as well as other organizations such as independent school districts, public housing authorities, faith-based or community-based organizations, and regional organizations. The announcement also notes that certain types of higher education institutions are encouraged to apply, including Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs. At the same time, the solicitation is clear about foreign participation restrictions: non-U.S. (foreign) institutions are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components as defined by HHS policy are not allowed.
Taken together, this grant opportunity is a focused, small-scale FDA-backed effort aimed at translating a specific candidate biomarker into a measurable, clinically testable assay and then using longitudinal human samples to see whether that biomarker can flag trastuzumab-related cardiac risk earlier than standard clinical detection, using a recognized cardiotoxicity definition and an established cardiac injury marker for comparison.Apply for RFA FD 17 006
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Developing Biomarkers for Trastuzumab-induced Cardiotoxicity" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on 2017-05-23.
- Applicants must submit their applications by 2017-07-24. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $140,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others.
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