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.”
ABOUT DIACARTA
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.
TECHNOLOGY PLATFORM
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.
Florida Selects DiaCarta’s cfDNA Test (RadTox™) for Statewide Use to Detect Early Response of Cancer Treatment
DiaCarta, a leading molecular diagnostics company specializing in personalized patient care through liquid biopsy, proudly announced that Florida Health Department selected “using plasma DNA concentration (DiaCarta’s RadTox™ test) for early detection of treatment response and resistance” through the Casey DeSantis Florida Cancer Innovation Fund. This fund supports deployment of the RadTox™ test throughout the State of Florida to be performed between Radiotherapy or Chemotherapy doses for real time detection of treatment response or resistance. The results will be as a real time predictor of imaging data.
DiaCarta Announces That the Oncuria® Bladder Cancer Tests Receive Medicare Coverage Effective January 1, 2024
DiaCarta proudly announced that the Oncuria® Bladder Cancer Tests, developed by Nonagen Bioscience and validated by DiaCarta as a Lab Developed Test (LDT), at its CAP-accredited and CLIA-certified laboratory, have received Medicare coverage effective January 1, 2024.
DiaCarta, Inc. and OncoAssure Ltd. Collaborate to Launch Prostate Cancer Lab Developed Test
DiaCarta, Inc. (“DiaCarta”), a pioneer in molecular diagnostic test development for cancer and infectious diseases, today announced that it has established a strategic collaboration with OncoAssure Ltd, an Irish medical diagnostics company. The focus of the collaboration is to commercialize OncoAssure’s groundbreaking Prostate test which is designed to identify patients with a lower risk of prostate cancer recurrence, guiding decisions on active surveillance or reduced monitoring post-treatment.
DiaCarta’s RadTox™ Test to Monitor Tumor Response Receives Medicare Coverage
DiaCarta, a leading molecular diagnostics company personalizing patient care through liquid biopsy, proudly announced that its revolutionary RadTox™ test, designed for tumor response monitoring, is now eligible for reimbursement from Medicare, effective January 1, 2024.
DiaCarta Launches OTC at Home Fecal Occult Blood Test to Complement its ColoScape™ Test
DiaCarta announced today that DiaCarta received US FDA 510(k) clearance for it’s over the counter (OTC) at home iColon Fecal Occult Blood Test (FOBT) that enables early detection of blood in stool at home, which is clinically relevant in gastrointestinal disorders and colorectal cancer.