DiaCarta Inc. has filed for EUA with the FDA and has received CE mark for its highly sensitive QuantiVirus™ SARS-CoV-2 Test Kit
By Claudia Li
/ March 25, 2020
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
By Wei Liu, Ph.D.
/ August 22, 2019
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
By Wei Liu, Ph.D.
/ April 18, 2019
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
By Wei Liu, Ph.D.
/ January 31, 2019
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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CIO Bulletin Announces DiaCarta Inc. As One of the 30 Fastest Growing Companies of 2018
By DiaCarta Inc.
/ January 17, 2019
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.
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Confirmation of NGS for False-negative Variants Using XNA Technology
By Wei Liu, Ph.D.
/ November 15, 2018
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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DiaCarta Inc. Launches Ultra-Sensitive TaqMan-Based qPCR Assays for Cancer Gene Mutation Detection
By DiaCarta Inc.
/ October 29, 2018
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.
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DiaCarta, Inc., Awarded $2 Million NCI Contract to Pursue Regulatory Approval of Innovative Cancer Radiation Response Blood Test
By DiaCarta Inc.
/ October 15, 2018
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.
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XNA Molecular Clamps Help Identify False-positive T790M Mutation
By Wei Liu, Ph.D.
/ October 9, 2018
Eighty five percent of the lung cancer patients are non-small cell lung cancer (NSCLC) patients. Among this population, patients with exon 19 deletion and L858R mutations respond well to the first (such as erlotinib and gefitinib) and second generation (such as afatinib and dacomitinib) of tyrosine kinase inhibitors (TKIs). However, all the respondents develop resistance after 9 to 14-month period and more than 50% of the resistance cases are due to the single point mutation at exon 20, T790M.
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Cancer Diagnostics: Targeted Gene Panels for Next Generation of Sequencing
By Wei Liu, Ph.D.
/ September 11, 2018
DiaCarta Named to MedTech Outlook’s Top 10 In-Vitro Diagnostic Technology Solution Providers 2018
By DiaCarta Inc.
/ July 31, 2018
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.
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DiaCarta Inc. Appoints Arrow Diagnostics as Exclusive Distributor for ColoScape™ in Italy
By DiaCarta Inc.
/ July 2, 2018
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.
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DiaCarta Named to CIO Applications’ “Top 25 Life Sciences Technology Vendors 2018”
By DiaCarta Inc.
/ June 4, 2018
CIO Applications has chosen DiaCarta as one of the Top 25 Life Sciences Technology Vendors 2018. The positioning is based on an evaluation of DiaCarta’s specialty in personalized diagnostics, translational genomics and clinical sample testing services provided in both US and China.
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