Press Releases

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.
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Press Releases

DiaCarta Announces Successful Completion of Oncuria® Validation Study with Nonagen Bioscience

DiaCarta, Ltd. (“DiaCarta”), a precision molecular diagnostics company, and Nonagen Bioscience Corporation (“Nonagen”), a cancer diagnostics company, today announced the successful completion of the validation study of Oncuria® multiplex bladder cancer immunoassay as a laboratory developed test (“LDT”). DiaCarta also announced that it has begun receiving patient urine samples for testing in its CLIA certified lab in Pleasanton, California.
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Press Releases

DiaCarta to Become a Publicly Listed Company Through Merger with HH&L Acquisition Co.

DiaCarta, Ltd., a precision molecular diagnostics company and developer of novel oncology and infectious disease tests, and HH&L Acquisition Co. (NYSE: HHLA.U, HHLA, HHLA WS) (“HH&L”), a publicly traded special purpose acquisition company (“SPAC”), today announced that they entered into a definitive business combination agreement (the “Business Combination Agreement”) that is expected to result in DiaCarta becoming a publicly listed company (the “Transaction” or “Business Combination”). The Transaction is expected to provide DiaCarta with access to the approximately $414 million cash from HH&L’s IPO proceeds held in trust, assuming no redemptions by HH&L’s shareholders and prior to the payment of transaction expenses, and potential additional financing to catalyze DiaCarta’s growth. The Transaction implies a pre-money equity value of $460 million for DiaCarta on a fully diluted basis and is expected to close in the first quarter of 2023. The Transaction positions DiaCarta to capitalize on significant future growth within existing and new markets.
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Blog

Dealing with the Respiratory Viruses that Cause Covid-19 or Flu

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Press Releases

DiaCarta Receives CE-IVD Mark for Its SARS-CoV-2 Flu A/B Combo Test

DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology and infectious disease tests announced today that the company has received CE-IVD mark for their newly developed QuantiVirus™ SARS-CoV-2 & Flu A/B Test.
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Press Releases

DiaCarta Expands Board Leadership with Industry Veteran

DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy, today announced the appointment of Jack Kaye, retired Partner with Deloitte LLP, as an independent board member who will serve as the Chairman of the Company's Audit Committee.
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Press Releases

DiaCarta Enters a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to Develop Cancer Tests based on its Novel XNA Technology

DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy today announced that the company, under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health, will collaborate on the evaluation and development of DiaCarta's proprietary xeno-nucleic acid (XNA) molecular clamping technology. NCI and DiaCarta will collaborate on the following projects: (1) the investigation of low frequency mutation events in cancers and rare diseases using DiaCarta's proprietary xeno-nucleic acid (XNA) molecular clamping technology, and (2) the development of XNA probes for in situ cancer cell detection. The duration of the CRADA will be 2 years from the effective start date.
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Diagnostic Developers Pursue SARS-CoV-2 Omicron Assays for Surveillance, Potential Clinical Use
GenomeWeb

Diagnostic Developers Pursue SARS-CoV-2 Omicron Assays for Surveillance, Potential Clinical Use

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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
Blog

Early Cancer Detection Will Save More Lives

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Assay Detects Precancerous Colorectal Cancer Lesions & Mutations
Blog

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
GenomeWeb

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
Blog

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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