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Ultra-precision diagnostics for ALK+ non-small cell lung cancer

US · IL NIH RePORTER grant awarded #nih-1R43CA298267-01A1

Summary

AleloPharma Inc. proposes to develop an ultra-precision liquid biopsy diagnostic test for detecting ALK translocation variants in ALK-positive non-small cell lung cancer (NSCLC) patients using their AleloMAX molecular detection system.

What they want

The project aims to develop an ultra-specific and ultra-sensitive molecular detection platform for EML4-ALK gene fusion translocations in ALK+ NSCLC, probing fusion RNAs using synthetic, in vitro-transcribed mRNAs. A clinical proof-of-principle study will then demonstrate the AleloMAX-ALK platform's resolution power and limit-of-detection using plasma- and/or blood-derived nucleic acid samples from ALK+ NSCLC patients, ALK- NSCLC patients, and healthy control volunteers. The ultimate goal is to develop a diagnostic kit for use in clinical labs and for a Phase II study.
Deliverables
  • Ultra-specific and ultra-sensitive molecular detection platform for EML4-ALK gene fusion translocations
  • Liquid biopsy test kit for detecting ALK translocation variants
Technical requirements
  • AleloMAX high-dimensional molecular detection system
  • 1-absolute copy per reacting assay limit-of-detection (LOD)

Risks & flags

Incumbent: AleloPharma Inc.

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

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