Press release

DiaCarta Inc. Receives CE Mark for Its Proprietary IVD Cancer Mutation Tests: KRAS, NRAS, EGFR and More

Feb 26, 2014 | Press Releases

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.

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DiaCarta Receives Accreditation by the College of American Pathologists (CAP)

DiaCarta, Ltd. (“DiaCarta”), a novel molecular diagnostic test developer for cancer and infectious diseases, today announced that it has received accreditation by the College of American Pathologists (CAP) for its CLIA certified lab. This accreditation is awarded to facilities that meet the high standards of quality, accuracy, and consistency in laboratory services required by CAP and underscores DiaCarta’s leadership and commitment to excellence.

DiaCarta Receives U.S. FDA Emergency Use Authorization for its Monkeypox Test Kit

DiaCarta, Ltd. (“DiaCarta”), a precision molecular diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for its QuantiVirus™ MPXV test, which is a PCR test for the qualitative detection of DNA from monkeypox virus (MPXV) in lesion swabs collected from individuals suspected of monkeypox infection.