DiaCarta Inc. Receives CE Mark for Its Proprietary IVD Cancer Mutation Tests: KRAS, NRAS, EGFR and More
DiaCarta, a technology-driven translational genomics and molecular diagnostics company located in Hayward, CA developing the most precise diagnostic products for cancer and infectious disease, today announced it has received CE Mark for its proprietary in vitro diagnostics (IVD) cancer mutation tests QClamp™ KRAS including codon 146 and 117, NRAS including codon 146, EGFR including T790M, all deletions and insertions, BRAF, JAK2 and PIK3CA. These mutation test kits can derive results in 2 hours directly from samples including FFPE, blood, and tissues without DNA purification. In addition, these mutation kits are highly sensitive and can be used on any commercial available Real-Time PCR machines.
QClamp™ is a revolutionary new way to screen for somatic mutations, which utilizes a sequence specific wild-type template Xeno-nucleic acid “Molecular Clamp” (XNA) that suppresses PCR amplification of wild-type template DNA and allows selective PCR amplification of only mutant templates. This allows the detection of mutant DNA despite a large excess of wild-type template from any sample, including FFPE and whole blood.
The QClamp™ technology is particularly suited to “liquid biopsy” applications for the detection of tumor-derived, cell-free DNA in plasma or urine, which can achieve sensitivities equivalent or even better than droplet digital PCR (ddPCR). Utilizing only standard qPCR real-time instrumentation, QClamp™ Real-Time PCR mutation tests are highly sensitive and can detect mutated DNA even when the concentration is below 0.1%.
“The problem with sequencing technology right now, if you take a tumor sample, it’s like a big haystack with a few needles in it,” Dr. Mike Powell, DiaCarta’s chief science officer, a veteran of Boehringer Mannheim and Roche Diagnostics, comments. “What we do is we eliminate the haystack from the equation. We burn the haystack and amplify the needles,” he said. The method also improves mutation detection because “with our XNA clamp, if you get a single nucleotide polymorphism, the mismatch causes a 15 to 20 degree difference in [melt] temperature” — a 10-fold increase over other PCR methods, he said.
“Recent studies have demonstrated that DNA sequencing is one of the least sensitive methods for characterizing mutation with only 10-20% of mutated DNA detected.” DiaCarta CEO and Founder Dr. Aiguo Zhang added that “Consequently, tumor driver mutations may not be detectable using standard DNA sequencing methods, especially in liquid biopsy applications like whole blood. Our QClamp products are the best alternative tools for the unmet market need.”
About DiaCarta Inc.
DiaCarta, based in Hayward, Calif., is developing and commercializing precise molecular diagnostic cancer assays that enable the most sensitive, reliable, and accurate detection of cancer biomarkers directly from a patient sample, including QClamp gene mutation tests, SuperbDNA gene expression assays, and QZol, the only PCR ready lysate solution. DiaCarta’s NRAS, EGFR, KRAS, BRAF, and PIK3CA tests are highly sensitive and able to detect a broad set of mutations and are being used by hospitals and cancer clinical laboratories and by biotechnology and pharmaceutical companies for clinical research.
DiaCarta announced that CIO Bulletin has named it among the 30 Fastest Growing Companies of 2018. The positioning is based on DiaCarta’s revenue growth, financial status, openness to innovation, global collaboration and partnership, flagship products launching, regulatory progress and ability to forecast future business and technology trends.
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.
DiaCarta 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.