Latest developments in Nanodiagnostics

Transcription

1 Latest developments in Nanodiagnostics Dr Eric Mayes, CEO

2 NANODIAGNOSTICS IN CANCER Why cancer? Second leading cause of death in noncommunicable disease Mechanisms of the disease are at the nanoscale First approved nanomedicines are cancer therapeutics and diagnostics 2014 WHO World Cancer Report Approximately 14 million new cases and 8 million cancer-related deaths in 2012 Cancer burden is projected to increase about 70% worldwide in just two decades The lowest-income countries with the leastdeveloped cancer services will be impacted greatest Questions for diagnostics: Where is it? What is it? Has it spread? Has it gone? Slide 2

3 CANCER CARE PATHWAY Where is it? Standard: Imaging (CT, MRI, Ultrasound, Endoscopy) Has it spread? Standard: Imaging (MRI, SPECT, PET) and tracing dyes (Blue, 99m Tc) Impalpable Lesion Chemotherapy Presentation during Examination or Screening Biopsy TNM Staging Surgery Palpable Lesion Radiotherapy What is it? Neoadjuvant Chemotherapy Standard: Biopsy, Histology, Immunohistochemistry Slide 3 Has it gone? Standard: Histologic margin assessment

4 WHERE IS IT? Concept: Using high surface area as a donor rather than receiver Prof. Sangeeta Bhatia (Laboratory for Multiscale Regenerative Technologies, MIT) Detail: Diagnostic test using engineered nanoparticles which release reporter peptides in the presence of colorectal cancer that are easily detected in the urine through an in vitro test Status: Successful at diagnosing colorectal cancer when injected into mice, promising a low-cost, noninvasive method of detection, but, despite the inclusion of an in vitro test, this is an in vivo nanomaterial and drug Slide 4 Warren et al. 2014: Point-of-care diagnostics for noncommunicable diseases using synthetic urinary biomarkers and paper microfluidics, PNAS 1119(10),

5 WHAT IS IT? Concept: Using digital molecular barcoding to assay mrna for cancer identification NanoString Technologies (Seattle, USA) Detail: In vitro test using two ~50 base probes per mrna that hybridize in solution the Reporter Probe carries a fluorescent barcode and the Capture Probe allows the complex to be immobilized for data collection Status: In September 2013, NanoString received FDA 510(k) clearance for the Prosigna breast cancer prognostic recurrence assay, its first commercially available in vitro clinical test Geiss et al. 2008: Direct multiplexed measurement of gene expression with color-coded probe pairs, Nat Biotechnol. 26(3), Slide 5

6 HAS IT SPREAD? Concept: Exploiting lymphatic drainage and the structures in lymph nodes to trap nanoparticles Endomagnetics (Cambridge, UK) Detail: In vivo marker of sentinel lymph nodes through the injection of magnetic nanoparticles and subsequent minimally-invasive surgical localisation using a handheld magnetometer Status: Marketed in Europe since November 2012 as a Class IIa medical device and treated over 2,500 breast cancer patients to date; recently expanded sales to Australasia and US pivotal trial to start in Q4 2014; expected to be first nanoparticle device approved by the FDA Slide 6

7 HAS IT GONE? Concept: Using fluorescent nanoparticle probes with targeting to highlight tumour margin Prof. Shuming Nie (Emory University and Georgia Tech) Detail: Indocyanine Green (ICG) nanoparticles are passively targeted in vivo using the EPR effect and visualised using a NIR imaging system called the Spectropen Status: Ex vivo pilot study at the University of Pennsylvania with five human patients has published, and the Spectropen and advanced nanoparticle agents are being developed by the Atlanta-based spinout, Spectropath Slide 7 Hold et al. 2014: Intraoperative Near-Infrared Imaging Can Distinguish Cancer from Normal Tissue but Not Inflammation, PLOS ONE 9(7), e103342

8 Thank you Slide 8