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DiaCarta Inc. Launches QClamp™ Somatic Mutation Real-Time PCR Tests for KRAS, NRAS, EGFR, BRAF, PIK3CA and More Without DNA Extractions

by | Oct 28, 2013 | Press Releases

DiaCarta is a new Translational Genomics and Molecular Diagnostics company located in the San Francisco Bay area and is pioneering novel molecular diagnostics technologies for detection of cancer biomarkers in human body fluids including saliva, blood and urine – so called ‘Liquid Biopsy’ in the field of Oncology, today announced it has launched its QClamp™ somatic mutation tests, highly sensitive and rapid tests for KRAS, NRAS, EGFR, BRAF, PIK3CA and more in 2 hours without DNA extraction.

QClamp™ is a revolutionary new way to screen for somatic mutations, which utilizes a sequence specific wild-type template xeno-nucleic acid “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 in the presence of a large excess of wild-type template from any type of sample including FFPE, needle biopsy, whole blood and urine. The tests take less than 2 hours from start to finish without DNA extraction using special Qzol direct PCR lysis buffer and can detect below 0.1% mutated DNA.

“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,” said Dr. Michael Powell, CSO of DiaCarta. “It has become clear that most if not all tumors are polyclonal and heterogeneous. Consequently, tumor driver mutations may not be detectable using standard DNA sequencing methods. Our QClamp™ tests are super sensitive and rapid. You don’t need to invest hundreds of thousands of dollar for a fancy digital PCR or sequencing machine. Our tests can be run on all currently available real-time PCR machines and everything to perform the tests is included in the kits.”

“We are very excited to launch this new product line to meet the unmet market,” said Dr. Aiguo Zhang, founder and CEO of DiaCarta. “We have received overwhelming responses from the field and our tests are the best in the market to address the issues with somatic mutation testing in oncology personalized diagnostics. We are in the process of CE Mark applications and expect to receive them by end of this year.”

About DiaCarta Inc.
DiaCarta, based in Hayward, Calif., is developing and commercializing in vitro diagnostics for a wide range of diseases based on branched DNA (bDNA) Signal Amplification technology and QClamp, proprietary technology platforms for gene quantification and somatic mutation tests. DiaCarta offers a suit of oncogene test and companion diagnostic development services including QuantiVirus® HPV E6/E7 mRNA for cervical cancer and QuantiVirus® HPV E6/E7 mRNA for head-neck cancer tests.

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DiaCarta Receives CE/IVD for its New COVID 19 Test that Identifies Delta Plus and New Variants

DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy today announced that its new QuantiVirus™ SARS-CoV-2 Variant Detection Test received the CE/IVD marking and therefore, can now be commercialized within the EU and rest of the world. This new test screens for the SARS-CoV-2 virus and simultaneously identifies and differentiates all the new mutating COVID 19 variants including the Alpha (UK), Beta (S. Africa), Gamma (Brazil), Delta (India), Delta Plus (India), Epsilon (California) and the Kappa (India) variants.

DiaCarta’s Novel XNA Technology Rapidly Detects Raging New SARS-CoV-2 Variants

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).

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