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.
According to the recent FDA SARS-CoV-2 Reference Panel Comparative Data released on September 15, among all the FDA EUA tests with returned results, DiaCarta’s QuantiVirusTM SARS-CoV-2 Test and QuantiVirus™ SARS-CoV-2 Multiplex Test both rank within the top 3 for product sensitivity.
DiaCarta’s QuantiVirus™ SARS-CoV-2 Multiplex Test ranks among the top 10 kits in terms of low limit of detection (LoD). DiaCarta is the top 6 company, after Perkin Elmer, Roche, Quest, RTA and BD Biosciences.
DiaCarta Receives Regulatory COFEPRIS Approval in Mexico & ICMR Approval in India for its FDA EUA Approved QuantiVirus™ SARS-CoV-2 Test
DiaCarta Inc., a precision molecular diagnostics company with a unique, patented XNA technology platform for the development of novel liquid biopsy tests, announced today that its QuantiVirus™ SARS-CoV-2 test has been approved for distribution in Mexico.
DiaCarta SARS-CoV-2 Test Detecting 3 Viral Genes Receives US FDA Emergency Use Authorization & Test Manufacturing Expanded to 500K COVID-19 Tests/Week
DiaCarta Inc, a precision molecular diagnostic company in CA, announced Thursday the US FDA granted Emergency Use Authorization for DiaCarta’s proprietary QuantiVirus™ PCR diagnostic (Dx) test specifically detecting three different genes of SARS-CoV-2, the virus causing the COVID-19 pandemic. DiaCarta recently expanded manufacturing capacity to 500,000 tests per week and is planning to expand to even larger (4x) scale manufacturing to meet the increasing demand for PCR tests to monitor COVID-19.
DiaCarta Inc. has filed for EUA with the FDA and has received CE mark for its highly sensitive QuantiVirus™ SARS-CoV-2 Test Kit
DiaCarta Inc., a precision molecular diagnostic company, announced today that it has filed for Emergency Use Authorization (EUA) with the US FDA for its QuantiVirus™ SARS-CoV-2 test and has validated the COVID-19 diagnostic test in its own CLIA certified lab in Richmond, CA to provide testing services for healthcare providers and patients. DiaCarta recently received Conformitè Europëenne (CE) Mark for its product.