DiaCarta Inc. Appoints Arrow Diagnostics as Exclusive Distributor for ColoScape™ in Italy
DiaCarta Inc is a personalized diagnostic company headquartered in Richmond, California and a leading developer of innovative, high-quality products for qPCR based assays using its proprietary QClamp® Xeno-Nucleic Acid (XNA) clamping technology, today announced that it has signed a distribution agreement with Arrow Diagnostics. Under the agreement, Arrow Diagnostics becomes sole distributor of ColoScape™ a multigene biomarker TaqMan qPCR in vitro diagnostic (CE-IVD) test in Italy, San Marino & Vatican City.
Colorectal cancer is a highly preventable disease and the detection of cancer gene mutations is not only critical for early detection of cancer development but also for targeted therapy and the monitoring of disease recurrence. This highly innovative test is configured to work both in cases where the DNA is derived from patient plasma so called “liquid biopsy” thereby requiring minimal invasive sampling making it convenient for patients and physicians and with current technology such as analysis of DNA derived from formalin fixed paraffin embedded (FFPE) tumor biopsy.
“DiaCarta is committed to working with the best distribution partners; those dedicated to customer service, cutting edge science and ultimately better patient care,” commented Aiguo Zhang, Ph.D., Founder and CEO of DiaCarta, Inc. “We are therefore delighted to have signed this agreement with Arrow Diagnostics who have a proven record of success in the highly competitive molecular diagnostics market.”
Dr. Gianluigi Mascarino, CEO of Arrow Diagnostics, said “The partnership with DiaCarta will generate significant value for our customers. We were impressed with DiaCarta’s QClamp® Xeno-Nucleic Acid (XNA) clamping technology and their commitment to innovation and especially by the flagship product, ColoScape™ CE-IVD test, which we believe will make a significant impact on colorectal cancer.”
Diacarta’s mission is to provide its customers with innovative precision molecular diagnostic tests that are faster, highly sensitive and that positively impact treatment plans and improve the well-being of patients.
DiaCarta is a translational genomics and personalized diagnostics company established in 2011, with a 16,000-square foot laboratory based in Richmond, California, housing their CLIA compliant facility, and a clinical laboratory facility in Nanjing with offices in Shanghai China. The company is well positioned as a leader in the new IVD (in vitro diagnostic) field with high precision detection of the circulating free tumor DNA (cfDNA) and is ISO13485 certified and manufactures IVD kits under cGMP such as EGFR, BRAF, KRAS, NRAS, EML4-ALK, ROS-1, PIK3CA the ColoScapeTM colorectal cancer mutation detection kits.
DiaCarta offers a range of testing services. From single-gene QClamp® qPCR tests to QClamp-NGS panels at its state-of-art CLIA certified facility.
The novel QClamp® Xeno-Nucleic Acid (XNA) clamping technology has solved the interference bottleneck of wild-type DNA in gene mutation detection and has successfully enhanced the sensitivity and specificity in the detection process. The technology can be widely used in quantitative PCR (qPCR), gene chip, nanotechnology and all generations of NGS platforms and is underpinned by over 80 patents.
ABOUT ARROW DIAGNOSTICS
Arrow Diagnostics S.r.l. was founded in 2003 and is based in Genoa, Italy. Arrow produces and distributes reagents, kits, and tools in molecular biology, virology, cell biology, microbiology, clinical diagnostics, pharmacogenetics, oncology, and immunology. It offers its products through sales representatives.
DiaCarta announced that it is launching a new suite of CE-IVD marked highly sensitive hydrolysis probe (TaqMan-qPCR) based QClamp® assays for detection of common cancer mutations in genes, such as KRAS, NRAS, BRAF, EGFR, PIK3CA and JAK2, using tissue biopsy (FFPE) and liquid biopsy (cfDNA) samples.
DiaCarta, Inc., Awarded $2 Million NCI Contract to Pursue Regulatory Approval of Innovative Cancer Radiation Response Blood Test
DIACARTA, Inc. announced today that it has received a $2 million National Cancer Institute (NCI) Small Business Innovation Research (SBIR) contract to continue development of its RadTox™ cfDNA radiation therapy toxicity monitoring test kit for cancer patients.
DiaCarta has been recognized as one of the Top 10 In-Vitro Diagnostic Technology Solution Providers 2018 by Med Tech Outlook Magazine. The positioning is based on an evaluation of DiaCarta’s specialty in genomic testing for biomarkers, personalized diagnostics and clinical sample testing service provided in their CLIA-certified lab.
CIO Applications has chosen DiaCarta as one of the Top 25 Life Sciences Technology Vendors 2018. The positioning is based on an evaluation of DiaCarta’s specialty in personalized diagnostics, translational genomics and clinical sample testing services provided in both US and China.
DiaCarta and MIODx Join Forces to Develop a Diagnostic Test to Predict Patient Responses to Immunotherapy
MIODx and DiaCarta announced today that they have entered into an agreement for the development of a diagnostic test for immunotherapy. The test is based on MIODx’s ClonoMap™ immune sequencing platform, and is designed to predict patient response to immunotherapy, which will be developed and validated at DiaCarta’s CLIA labs in both the San Francisco Bay Area and Nanjing, China.