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Press Releases

DiaCarta’s Multivariant COVID-19 Test Accurately Detects the Omicron Variant

DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy announced today that the company has developed a novel test to detect the newest COVID-19 Omicron variant, based on its proprietary XNA technology.
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Early Cancer Detection Will Save More Lives
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Early Cancer Detection Will Save More Lives

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Assay Detects Precancerous Colorectal Cancer Lesions & Mutations
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Assay Detects Precancerous Colorectal Cancer Lesions & Mutations

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Press Releases

DiaCarta and the Scientific World Mourns the Passing of CSO, Michael J. Powell, Ph.D.

DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel virology and oncology tests, mourns the passing of Michael “Mike” J. Powell, Ph.D., Chief Scientific Officer of DiaCarta.
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SARS-CoV-2 Delta Variant PCR Could Help Surveillance Efforts, Developers Say
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SARS-CoV-2 Delta Variant PCR Could Help Surveillance Efforts, Developers Say

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Press Releases

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.
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DiaCarta Positioning Liquid Biopsy Assay to Gauge Chemotherapy Response in Multiple Cancers
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DiaCarta Positioning Liquid Biopsy Assay to Gauge Chemotherapy Response in Multiple Cancers

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Press Releases

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.
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Press Releases

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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Press Releases

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.
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Publications

Kinetics of Plasma cfDNA Predicts Clinical Response in Non‑Small Cell Lung Cancer Patients

Tyrosine kinase inhibitors (TKIs), VEGF/VEGF receptor inhibitors (VEGFIs) and immune checkpoint inhibitors (ICIs) have revolutionized the treatment of advanced cancers including non‑small‑cell lung cancer (NSCLC). This study aims to evaluate the utility of plasma cell‑free DNA (cfDNA) as a prognostic biomarker and efficacy predictor of chemotherapy (CT) with or without these precision therapies in NSCLC patients. Peripheral cfDNA levels in 154 NSCLC patients were quantified before and after the first target cycle of chemotherapy. The correlations of cfDNA with tumor burden, clinical characteristics, progression‑free survival (PFS)/disease‑free survival (DFS), objective response ratio (ORR), and therapy regimens were analyzed respectively. Baseline cfDNA, but not post‑chemotherapeutic cfDNA, positively correlates with tumor burden. Notably, cfDNA kinetics (cfDNA Ratio, the ratio of post‑chemotherapeutic cfDNA to baseline cfDNA) well distinguished responsive individuals (CR/PR) from the non‑responsive (PD/SD). Additionally, cfDNA Ratio was found negatively correlated with PFS in lung adenocarcinoma (LUAD), but not lung squamous‑cell carcinoma (LUSC) which may be due to a limited number of LUSC patients in this cohort. LUAD patients with low cfDNA Ratio have prolonged PFS and improved ORR, compared to those with high cfDNA Ratio. When stratified by therapy regimen, the predictive value of cfDNA Ratio is significant in patients with chemotherapy plus VEGFIs, while more patients need be included to validate the value of cfDNA Ratio in other regimens. Thus, the kinetics of plasma cfDNA during chemotherapy may function as a prognostic biomarker and efficacy predictor for NSCLC patients.
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Publications

A high-throughput Anti-SARS-CoV-2 IgG testing platform for COVID-19

Highlights •A new immunoassay was developed for anti-SARS-CoV-2 IgG detection. •The assay is based on Luminex platform and has specificity <98 %. •The assay shows sensitivity > 97.5 % for patients beyond 2 weeks after symptom onset. •Serum heat-activation is not suitable for this beads-based fluorescence immunoassay.
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Press Releases

FDA Report: DiaCarta COVID-19 Tests Rank Top 3 Among FDA SARS-CoV-2 Reference Panel Tests

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.
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Press Releases

DiaCarta’s COVID-19 Test Ranks Top 10 Among All FDA EUA Tests Based on Limit of Detection

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.
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Press Releases

DiaCarta Receives Regulatory COFEPRIS Approval in Mexico & ICMR Approval in India for its FDA EUA Approved QuantiVirus™ SARS-CoV-2 Test

DiaCarta Inc., a precision molecular diagnostics company with a unique, patented XNA technology platform for the development of novel liquid biopsy tests, announced today that its QuantiVirus™ SARS-CoV-2 test has been approved for distribution in Mexico.
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Press Releases

DiaCarta SARS-CoV-2 Test Detecting 3 Viral Genes Receives US FDA Emergency Use Authorization & Test Manufacturing Expanded to 500K COVID-19 Tests/Week

DiaCarta Inc, a precision molecular diagnostic company in CA, announced Thursday the US FDA granted Emergency Use Authorization for DiaCarta’s proprietary QuantiVirus™ PCR diagnostic (Dx) test specifically detecting three different genes of SARS-CoV-2, the virus causing the COVID-19 pandemic. DiaCarta recently expanded manufacturing capacity to 500,000 tests per week and is planning to expand to even larger (4x) scale manufacturing to meet the increasing demand for PCR tests to monitor COVID-19.
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Press Releases

DiaCarta Inc. has filed for EUA with the FDA and has received CE mark for its highly sensitive QuantiVirus™ SARS-CoV-2 Test Kit

DiaCarta Inc., a precision molecular diagnostic company, announced today that it has filed for Emergency Use Authorization (EUA) with the US FDA for its QuantiVirus™ SARS-CoV-2 test and has validated the COVID-19 diagnostic test in its own CLIA certified lab in Richmond, CA to provide testing services for healthcare providers and patients. DiaCarta recently received Conformitè Europëenne (CE) Mark for its product.
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KRAS Codon 12 Mutations and Detection
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KRAS Codon 12 Mutations and Detection

Next-generation sequencing (NGS) is a powerful tool that has seen a fast increase in clinical labs although only a few NGS tests have been approved by the FDA. However, there have been a lot of debate on if variants from NGS sequencing should be confirmed either by Sanger sequencing, the gold standard, or other techniques such as quantitative PCR, or the combination, or other methods.
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HPV-driven Cancers and Somatic Mutations in These Cancers
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HPV-driven Cancers and Somatic Mutations in These Cancers

Next-generation sequencing (NGS) is a powerful tool that has seen a fast increase in clinical labs although only a few NGS tests have been approved by the FDA. However, there have been a lot of debate on if variants from NGS sequencing should be confirmed either by Sanger sequencing, the gold standard, or other techniques such as quantitative PCR, or the combination, or other methods.
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cfDNA Quantitation for Research and Clinical Applications
Blog

cfDNA Quantitation for Research and Clinical Applications

Next-generation sequencing (NGS) is a powerful tool that has seen a fast increase in clinical labs although only a few NGS tests have been approved by the FDA. However, there have been a lot of debate on if variants from NGS sequencing should be confirmed either by Sanger sequencing, the gold standard, or other techniques such as quantitative PCR, or the combination, or other methods.
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