Attendee search 

Company Background

Firefly is introducing a universal technology platform for biomarker detection with a broad range of applications in life sciences, agriculture, veterinary medicine, and human diagnostics. Firefly BioWorks is a spin-out of the Chemical Engineering Department at the Massachusetts Institute of Technology (MIT), where the founders developed a novel method for high-throughput production of complex microparticles. The company began operations in 2010 and grew to seven full-time employees through a combination of SBIR awards and angel funding. The company is focused on developing multiplexed assays for biomarker detection that scale from discovery to clinical diagnostics. The company has adopted a lean startup approach. The first minimum viable product is being launched and operations will be scaled according to demand.

Technology Overview

Firefly develops and manufactures next-generation microparticles for biomolecule detection. The company’s first product, a kit for detecting microRNA aimed at the research market, has just been launched commercially. Firefly’s core technology, Optical Liquid Stamping, was developed by combining photolithography (typically used in microchip production) with microfluidics. This method allows fabrication of microparticles with virtually any shape, chemistry, and biofunctionality. Using Optical Liquid Stamping, Firefly developed a barcoded particle architecture that enables multiplexed biomarker detection on standard laboratory instrumentation. Through the support of the NCI SBIR Program, Firefly developed a particle-based assay for high-throughput profiling of microRNAs, a class of molecules with enormous potential for early diagnosis of cancer. 

Market Potential 

Firefly operates in the global market for biotechnology tools, a market that generates approximately $70 billion in worldwide sales. Firefly developed its first product for microRNA profiling, a market currently estimated at approximately $100 million and expected to grow very rapidly. Several market surveys indicate that bead-based assays for high-throughput/mid-multiplexing profiling are expected to address a critical need in the industry and grow at the fastest rate, especially in the area of microRNA.

Competitive Advantage

The Firefly platform enables detection of clinically relevant biomolecules with an unprecedented combination of performance, flexibility, throughput, and cost. Additionally, the assay developed by Firefly allows direct detection of miRNA in clinical samples without purification. This eliminates protocol discrepancies in RNA purification and will likely lead to more reliable diagnostics.

Beyond microRNA, Firefly’s platform has been used for the detection of disease-related proteins, mRNAs, and genomic DNA. The technology naturally lends itself to simple bedside or handheld devices that can be used in routine screens for early disease detection or point-of-care diagnostics.

Financial Overview

Initial funding was provided by two Phase I SBIR awards, for a total of about $500,000, followed by a seed round of $1 million from angel investors. In August 2011, Firefly was awarded a $2 million NCI SBIR Phase II award that catalyzed a $2 million second round of angel funding used for commercial development in the research market. Firefly seeks an industry partner to adopt the company’s technology and estimates additional funding in the $10 to $20 million range is required to expand its diagnostics capabilities.

Intellectual Property

Firefly has obtained an exclusive license from MIT for use of its technology in any research or clinical diagnostics application. The company’s current IP portfolio comprises four issued patents and 16 pending applications, covering the entire value chain of Firefly products from particle fabrication, encoding and bio-functionalization, to custom microRNA assays and readout in standard instrumentation.

Commercialization Strategy

Firefly’s long-term goal is to become a trusted provider of reliable and cost-effective solutions for clinical diagnostics. The company plans to first establish a presence in the research market and eventually enter the diagnostics field. Firefly intends to grow the company in three phases:

• Selling initial products to leading academic laboratories.
• Partnering with flow cytometry manufacturers for co-marketing of products.
• Expanding the product offering to include diagnostic applications by partnering with content developers in the cancer space.

Pipeline Products

Firefly’s first product is a custom 25-plex microRNA profiling kit that can be used on standard benchtop cytometers. The next generation of products will offer expanded multiplexing, a larger set of supported cytometers, and sensitivity that rivals polymerase chain reaction (PCR). Once the company has proven the technology in the field of microRNA, it will enter the protein market, with a set of companion products with relevance in both research and diagnostics.

Management Team

Firefly has built a team of executives and business advisors with deep expertise in molecular assays, microfluidics, materials, computer science, flow cytometery, and protein science, with roots in both start-ups and large life-science corporations. The team includes:

Operational Team:

Davide M. Marini, Ph.D., Co-founder, Chief Executive Officer

Daniel C. Pregibon, Ph.D., Co-founder, Chief Technology Officer

Andreas Windemuth, Ph.D., Chief Information Officer

Isaac B. Stoner, Vice President of Product Development

Andrea K. Bryan, Ph.D., Director of Engineering

Directors: 

Roger Dowd and Rick Ryan

Business Advisory Board: 

Joseph Gentile, Martin Madaus, Ph.D., Paul B. Manning, Ian Ratcliffe, and Michael P. Rubin, M.D., Ph.D.

Scientific Advisory Board: 

David P. Bartel, Ph.D., and Patrick S. Doyle, Ph.D.

Company Background Vala Sciences, Inc., was incorporated in March 2004 as a C corporation in Calif. Many members of the core team have worked together as part of similar business ventures at Q3DM, Inc., and Beckman Coulter. Vala was spun out from Q3DM, Inc., a venture- and grant-financed company purchased by Beckman Coulter in December 2003. In August 2009, the company reacquired the Q3DM patent portfolio. The Q3DM-Vala intellectual property combination creates a substantial patent portfolio, which helps solidify Vala’s place in the marketplace. The aggregate successful experience of managing Q3DM from start-up to acquisition by Beckman Coulter, positions Vala well for long-term commercial success. Technology Overview Vala’s multiplex technology, currently in preclinical development, brings quantitative innovation to diagnostic and prognostic clinical testing. The company’s technology uses haptens and quantum dots to enable multiple biomarkers to be simultaneously localized and quantified on a cell-by-cell basis, on a single-tissue section. This unique approach greatly enhances the data that can be generated from single-tissue sections, thereby allowing a much richer data set to be obtained than is possible using current standard immunohistochemical (IHC) techniques. Multiplex imaging on a single slide means that more data can be obtained from a very small tissue sample, such as a needle biopsy, compared with traditional techniques. Vala’s breast cancer biomarkers of interest include estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor (HER2).  Market Potential  The increasing incidence of cancer in an aging population and the growing use of targeted cancer drugs requiring companion diagnostics drives the rising need for automated testing and standardization that Vala’s tools provide. The world microscopy market is expected to grow from $2.7 billion in 2010 to $4.5 billion in 2015, at an estimated CAGR of 10.8 percent from 2010 to 2015. Quantum dot nanotechnology in microscopy is a growing area of interest and is expected to drive the future growth of microscopy market. Nanotechnology currently accounts for a meager 10 percent of the market; however, it is expected to grow the fastest pace during the forecasted 2010 – 2015 period at a CAGR of 17.9 percent (reportlinker.com World microscopy market 2011).  Vala’s technology is at the cutting edge of multiplex biomarker imaging and, when combined with their state of the art whole slide scanning and image analysis technology, Vala is well positioned to become an industry leader in predictive and prognostic cancer diagnostics.  Competitive Advantage  Vala’s multiplex biomarker technology utilizes hapten-conjugated antibodies to allow antibodies from the same species to be used simultaneously, a major restriction in traditional IHC techniques. The company is combining that advantage with quantum dot conjugated secondary antibodies due to their enhanced fluorescence and lack of photo bleaching. Slides labeled with quantum dots will remain fluorescent after at least a year, making them suitable for archiving; this is not possible using many other fluorescent dyes. Vala’s assays localize multiple biomarkers in the same slide, therefore reducing the amount of human tissue needed. This is a real problem when patients have needle biopsies, for example, as the volume of tissue biopsied is very small, meaning that the number of slides that can be generated from that sample is extremely limited. Financial Overview  To date, Vala Sciences, Inc., has raised a total of $17 million from a combination of private equity, federal and state grants/contracts, and commercial revenue. Vala is seeking to raise an additional $5 million to allow the company to complete development, obtain regulatory clearance, and introduce its product to the market.  Intellectual Property  Vala’s 19 patents and patent applications are thought to comprise one of the largest, most competitive patent portfolios in the High Content instrumentation market.  Commercialization Strategy  Vala is developing strategic partnerships to commercialize the breast cancer assay as a Laboratory Developed Test (LDT). The company will then obtain FDA approval for the assay, whole slide scanning image capture, and image analysis system as a Class III medical device. Vala also plans to market FDA-approved diagnostic reagent kits to clinical labs.  Pipeline Products  Vala’s technology currently focuses on multiplex imaging in breast cancer; however, it is readily adaptable to address questions in a wide range of cancers, including prostate cancer. Management Team  Vala Sciences has a strong leadership team with combined experience in molecular pathology, cell biology, and bioengineering. Key members include: Jeff Price, M.D., Ph.D., is the former Chief Executive Officer of Q3DM, Inc. Dr. Price is also an Associate Professor at The Sanford-Burnham Medical Research Institute. Patrick McDonough, Ph.D., has more than 25 years of experience in cell biology and a history of success developing commercial products. Randy Ingermanson, Ph.D., has more than 20 years of algorithm and software engineering experience James Evans, Ph.D., has a background in molecular cell biology and imaging informatics and is the former Assistant Director of the Whitehead MIT BioImaging Center.