During treatment for cancer, patients receive multiple doses of highly toxic drugs. These drugs/doses may be ineffective or even more toxic if mixed or stored improperly, or compounded with substandard ingredients1,2. Publications have reported that contamination with bacteria/fungi or endotoxins during mixing has sickened/killed patients3. Because there is no on-site (Point-Of-Care) technology to assess dose composition, quality, formulation, and/or contamination, doses are very rarely checked – it is assumed doses are formulated correctly. If checked after formulation and immediately prior to administration, adverse patient reactions and deaths can be avoided. There is no competitor presently that can do it as efficiently as our proposed approach. There is clearly a need.

Using our proprietary Raman spectroscopy-based technology, we will create and commercialize an analytical device for real-time validation of proper formulation of parenteral cancer chemotherapy drugs by comparing formulated doses with reference chemotherapy standards and databases.

Internal marketing research has determined the customers for our technology and proposed device are oncology clinics/practices (in-hospital, outpatient) and specialty pharmacies. According to the American Society of Clinical Oncology, more than 2000 US sites exist where chemotherapy is mixed for treating patients. Our proposed solution introduces the capability to verify safe formulation for more than 20M doses currently given annually. We predict annual revenues of more than $4M (2026) and more than $13M (2028).

Our proposed approach has been applied and validated across a number of other analogous applications. For example, devices based on the same technical approach have been created for automated molecular urinalysis and detecting criminal diversion of narcotics. The proposed device – ProofMed-CH™ Scanner V1.0 – will analyze 10 samples in a single 20-minute cycle. Based on our experience and established design/fabrication/manufacturing framework, this device will be validated and beta-tested within 18 months.

1 Sidhu J, Gogoi MP, Agarwal P, Mukherjee T, Saha D, Bose P, Roy P, Phadke Y, Sonawane B, Paul P, Saha V, Krishnan S. Unsatisfactory quality of E. coli asparaginase biogenerics in India: Implications for clinical outcomes in acute lymphoblastic leukaemia. Pediatr Blood Cancer. 2021 Nov;68(11):e29046. doi: 10.1002/pbc.29046. Epub 2021 May 3. PMID: 33939263; PMCID: PMC7613163

2 Gilbert RE, Kozak MC, Dobish RB, Bourrier VC, Koke PM, Kukreti V, Logan HA, Easty AC, Trbovich PL. Intravenous chemotherapy compounding errors in a follow-up Pan-Canadian observational study. J Oncol Pract. 2018 May;14(5):e295-e303. doi: 10.1200/JOP.17.00007. Epub 2018 Apr 20. PMID: 29676947; PMCID: PMC5952328.