Proteomics firms received more than $8.75 million in grants and tax credits awarded this week through the Qualifying Therapeutic Discovery Project Program, an initiative created by the Patient Protection and Affordable Care Act.
Based on the grant descriptions, a large proportion of the money, which is being provided by the Internal Revenue Service, will go toward diagnostics research, with a number of prominent proteomics-based diagnostics developers among the awardees.
Clinical proteomics firm Somalogic received one of the largest awards — worth more than $1.9 million — to fund a series of projects including development of protein-based diagnostics for non-small cell lung cancer, ovarian cancer, pancreatic cancer, and chronic kidney disease. The company has partnered with Quest Diagnostics to commercialize the pancreatic and lung cancer tests, with a laboratory-developed version of the lung cancer diagnostic slated for launch next year and a US Food and Drug Administration-approved version planned for 2012. It has begun a roughly 400-patient validation trial for its pancreatic cancer diagnostic, which it plans to complete within a year (PM 10/15/2010).
Also included in the $1.9 million award was $244,479 for research into the development of an inexpensive multiplexed blood-based diagnostic platform capable of testing multiple diseases.
Diagnostics company Biodesix, whose CEO David Brunel is a co-founder and former president of Somalogic, also received one of the larger awards — $1.4 million. Of that funding, $244,479 will go toward the company's VeriStrat protein-biomarker test, which launched commercially in May 2009 as a companion diagnostic to identify lung cancer patients likely to benefit from epidermal growth factor targeted therapy.
This June, Jennifer Hedrick, senior director of marketing at Biodesix, told ProteoMonitor that the company was looking to expand use of VeriStrat to other diseases, including colorectal, head and neck, and pancreatic cancer (PM 06/25/2010). The QTDP award is for research into the use of VeriStrat for guiding EGRF inhibitor therapy in cancer generally, suggesting that it will be used as part of these efforts.
The award will also fund research into the company's CancerDetect test for the early detection of lung cancer as well as the development of mass spec-based diagnostics for prostate cancer, inflammatory colitis, and autoimmune liver disease.
Seattle-based Integrated Diagnostics received $733,437 for research into tests for the early detection of lung cancer and Alzheimer's disease. In July, the company secured $10 million in private funding, which it said it would use for verification studies to establish clinical feasibility for protein biomarker panels for at least one, and possibly both, of these diseases (PM 08/06/2010).
Quanterix also received $733,437 through the QTDP. The company will use the award to fund research into a blood-based diagnostic for Alzheimer's disease, a companion diagnostic to predict response to Crohn's disease therapy, and the development of its single-molecule array technology for monitoring the recurrence of prostate cancer.
In June, David Duffy, the company's senior director of platform research, told ProteoMonitor that it plans to launch the prostate cancer diagnostic as a laboratory-developed test in 2011 and to bring the Alzheimer's diagnostic to market in 2012 (PM 06/11/2010).
Diagnostics firm Vermillion, which launched commercial sales of its OVA1 protein biomarker-based ovarian cancer test in March, received $488,958 through the program for the development of OVA2 — an expanded version of OVA1 — and Vasclir, a biomarker blood test for peripheral artery disease. During its second-quarter earnings call in August, Eric Fung, Vermillion's chief science officer, cited those diagnostics as the primary focus of the company's current R&D efforts (PM 08/13/2010).
Correlogic Systems received $244,479 for work on multivariate protein-based assays for ovarian and breast cancers. An increased emphasis on breast cancer diagnostics would mark a shift for the company, which over the last decade has focused primarily on its ovarian cancer test OvaCheck. Correlogic filed a 510(k) application for OvaCheck with FDA in December of 2008 but withdrew it in April after being told that the patient population used in the clinical trial for the test was not satisfactory, and is currently undertaking the "second arm" of the trial, upon completion of which it plans to file another 510(k) submission.
In July, the company filed for Chapter 11 bankruptcy, and in October was granted the right as part of its restructuring to reject OvaCheck licensing agreements with Quest Diagnostics and Laboratory Corporation of America (PM 10/08/2010).
Insilicos, which in October used a $1.2 million Small Business Innovation Research grant to launch a 400-subject study evaluating its protein biomarker-based cardiovascular disease diagnostic PreClue, received an additional $244,479 to fund the development of the test (PM 09/24/2010). Other companies winning grants for diagnostics work include Predictive Biosciences, which received $488,958 for bladder cancer prognosis and recurrence tests; Astute Medical, which received $244,479 for the development of a biomarker panel for the early detection of acute kidney injury; and Theranostics Health, which was awarded $244,479 for molecular diagnostics aimed at guiding therapies for metastatic cancer patients.
Proteomics tools and assay development projects also received funding through the program, although at a considerably lower level than diagnostics work. Cell Biosciences received $244,479 for the development of its nanoimmunoassay platform, which has recently shown utility as a tool for studying protein phosphoisoforms (PM 10/15/2010). Tools company BioScale was awarded $244,479 to continue work on its Acoustic Membrane Microparticle protein detection system (PM 06/18/2010). And biotech firm Prognosys Biosciences received $66,428 for research into methods of mapping protein kinase activity across the proteome.
Pressure Biosciences won $244,479 to continue development of its pressure cycling technology, which the company has been marketing as a tool for mass spectrometry sample prep and extracting proteins from formalin-fixed paraffin embedded tissues, a common form of tissue sample.
CytoScale Diagnostics, a start-up formed this April by recent graduates of the University of California, Los Angeles, MBA program, secured $244,479 for the development of circulating tumor cell cancer diagnostic devices. In May, the company signed a letter of agreement with the Regents of the University of California to exclusively license a chip-based microfluidic image-cytometry platform developed by a team of UCLA researchers and capable of detecting proteins in samples as small as 1,000 cells (PM 08/06/2010).