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.
Former AstraZeneca Personalized Healthcare Strategy Leader Named Senior Vice President of Companion Diagnostics at DiaCarta
DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy, today announced the appointment of Hongjun “Harry” Yang, Ph.D., former Executive Personalized Healthcare Strategy Leader at AstraZeneca, as Senior Vice President of Companion Diagnostics (CDx) at DiaCarta.
DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy today announced the publication of a study entitled “A Rapid SARS-CoV-2 Variant Detection by Molecular-Clamping Based RT-qPCR” in MedRxiV that demonstrates the enhanced sensitivity and specificity using its proprietary XNA based Molecular Clamping Technology that uses innovative synthetic Xenonucleic acid molecular oligomers (XNA) that hybridize with target wild-type DNA sequences, acting as molecular clamps, to enable the accurate amplification of mutant sequences only, using quantitative real-time polymerase chain reactions (qPCR).
DiaCarta Announces Publication in Nature Scientific Reports Demonstrating cfDNA Biomarker Algorithm Predicts Response and Outcome of Chemotherapy
DiaCarta Inc., a precision molecular diagnostics company with proprietary technologies for the development of novel liquid biopsy oncology tests, announced today the publication of a study in Nature Scientific Reports that demonstrates that DiaCarta’s cfDNA biomarker algorithm could function as a prognostic biomarker and efficacy predictor for non-small cell lung cancer (NSCLC) patients.
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.