SAN DIEGO, May 16, 2018 /PRNewswire/ -- BioFluidica, a privately held cancer diagnostics company, today announced the continuation of a highly successful small patient study to replace painful bone marrow biopsies through a simple blood test for Acute Myeloid Leukemia. The larger study sponsored by a $1.5 million Phase 2 Award from Small Business Innovation Research enrolls and tracks 40 patients with Acute Myeloid Leukemia, a type of cancer of the blood and bone marrow, in a one-year pilot study to search for minimal residual disease (cancer cells undetected after treatment) and for possible onset of relapse following therapy.
Success will be gauged by the ability of BioFluidica's patented Liquid Scan® cartridge technology to detect relapse, as signaled by changes in Circulating Leukemic Cells before cytology testing from the usual bone marrow biopsy.
Rolf Muller, CEO of BioFluidica, states that with BioFluidica's technology, "We are able to program microfluidic chips to isolate any kind of diagnostically relevant cell from blood samples whether from solid tumors or blood cancer. In the case of AML we are detecting complex panels of Circulating Leukemic Cells (CLCs) to monitor cancer recurrence. The expansion of BioFluidica's technology into the blood-born cancers is added to the clinical validation we have already achieved from 9 other cancers including lung, breast, pancreatic, prostate, and colorectal cancer. The high through-put instrumentation for cell isolation will now be used in clinical trials."
"We are further developing the platform to be a universal technology capable of isolating all three oncological markers: cell-free DNA, exosomes, and CTCs," says Dr. Steven A. Soper, CTO, "but more importantly, the isolated material has to be fully compatible with downstream genetic analysis, which requires high purity isolates."
"These combined technological breakthroughs promise to revolutionize cancer diagnostics and speed the adoption of personalized medicine," adds Muller.
BioFluidica's Liquid Scan® platform consists of simple instrumentation that works in conjunction with a disposable, test-specific chip that can run multiple patient samples at the same time and extremely quickly through parallel processing. The heart of the system is a highly efficient cell capture bed, comprised of hundreds of microfluidic channels. In a sample with five million white blood cells and five billion red blood cells, for instance, only one viable CTC may be present, yet BioFluidica's diagnostic can find it, and with unmatched accuracy. The recovery and purity for the chip technology is unprecedented, as well, reaching over 95% and 80%, respectively.
While BioFluidica is using AML as an example in this trial, the system can be used to longitudinally track any patient and search for signs of relapse following therapeutic intervention. Since the instrument uses a small blood draw, there is no need for a bone marrow biopsy and the accompanying discomfort to the patient. This allows for more frequent testing which can be particularly important for acute-based diseases, such as AML and other acute leukemic diseases, such as Multiple Myeloma (MM) or Acute lymphoid leukemia (ALL). BioFluidica's associated automated hardware also supplies a workflow conducive to clinical implementation by operators not well trained in the art. Finally, the fluidic chip is manufactured in plastic via injection molding—a patented off-shoot of CD/DVD techniques--allowing for scaled production at low cost and with the high compliance necessary for in vitro diagnostic assays.
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