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Apr 27, 2020

Proscia: Concentriq Dx

Proscia has launched its Concentriq Dx digital pathology software in the US. The software can be used for reviewing and reporting digital pathology slides from remote locations, such as home offices, using an internet browser. Concentriq Dx was CE marked in November 2019. According to Proscia, Concentriq Dx will support the need for remote pathology in US during the coronavirus pandemic. The US Food and Drug Administration recently issued new guidance allowing the greater availability of remote digital pathology services during the pandemic. 

 
Apr 22, 2020

Skyline Dx: Merlin Assay

Skyline Dx launched the Merlin Assay for melanoma as a laboratory-developed test available through its CLIA/CAP facility in San Diego. According to the Rotterdam, Netherlands-based company, a recently published study found the test could reduce up to 42 percent of surgical interventions in patients diagnosed with melanoma. The assay was developed as a result of the Falcon R&D Program, a partnership between clinicians and academia to develop tools for optimizing the clinical pathway of melanoma patients. 

Apr 22, 2020

Centogene CentoSwab

Centogene has launched CentoSwab, a sample collection kit that is validated for pharyngeal sampling for the detection of SARS-CoV-2, the virus that causes COVID-19. The kit consists of a swab and a collection tube and will be distributed globally.

Apr 22, 2020

Caris Life Sciences MI Exome

Caris Life Sciences has launched MI Exome, a whole-exome next-generation sequencing-based assay.

The test covers 22,000 genes and detects point mutations, indels, copy number alterations, and about 250,000 exonic, intronic, and intergenic SNPs. MI Exome also includes analysis of tumor mutational burden, microsatellite instability, loss of heterozygosity, and homologous recombination deficiency, and can be used to interrogate bacteria, viruses and fungi, including cancer-related pathogens, to support microbiome analysis. Average turnaround time is less than 14 days. When paired with the Caris Molecular Intelligence profiling services, the test can help detect and characterize cancer to guide individualized treatment decisions, the company said.

Apr 21, 2020

Biocept RUO Target Selector Kits

Biocept has announced the availability of new research-use-only kits allowing molecular laboratories to perform some of its Target Selector molecular assays in house on both formalin-fixed paraffin-embedded tissue and circulating tumor DNA samples. The first available kits, for EGFR mutations, are being made available now and additional assays targeting other oncogene mutations are planned for launch in the future, Biocept said.
 
The firm's Target Selector technology platform utilizes patented "Switch-Blocker" technology to enrich specimens for specific mutations of interest, resulting in high assay sensitivity and specificity. According to the company, this high performance allows detection of minute fractions of mutated DNA in a liquid biopy sample, and could also allow laboratories to eliminate macro-dissection of tumor blocks or provide results with small DNA inputs compared to most tissue-based assays. Target Selector assays can be used in combination with a variety of low-cost analytical platforms including qPCR, Sanger sequencing, microarrays, and mass-spectrometry, in addition to next generation sequencing, the firm said. 
Apr 17, 2020

Randox: Qnostics SARS-CoV-2 Molecular Controls

Randox has launched whole pathogen molecular controls for SARS-CoV-2. The controls were developed by UK scientists and are being made available by Randox under the Qnostics brand name. The controls are for use to ensure accurate coronavirus test and system performance and are manufactured using whole pathogens to mimic the patient sample. The controls contain the entire SARS-COV-2 genome, incuding conserved regions recommended by the US Centers for Disease Control and Prevention and the World Health Organization, and they are compatible for use with commercial and in-house testing methods. 

Apr 16, 2020

Eurofins Genomics US SARS-CoV-2 Plasmid DNA Controls

Eurofins Genomics US and its subsidiary BlueHeron Biotechnology have launched three SARS-CoV-2 plasmid DNA controls for verifying the presence of the virus. The controls are intended for use in both R&D and diagnostic applications and target key segments in the virus genome. One of them, CVGP, covers a large part of the viral sequence.

Apr 15, 2020

Bio-Techne ExoDx Prostate Test At-Home Collection Kit

Bio-Techne has launched the Exosome Diagnostics ExoDx Prostate Test At-Home Collection Kit for patients who are concerned about their prostate health.

The ExoDx Prostate or EPI test is a urine-based genomic test that helps inform the prostate biopsy decision.

Due to shelter in place orders issued to reduce the spread of COVID-19, appointments have been cancelled for millions of men for important procedures such as biopsies to detect the presence of prostate cancer, the firm noted. The at-home collection kit enables physicians and their patients to employ a telehealth solution when patients share frustration, anxiety, and fear over whether they might harbor high-grade prostate cancer, Bio-Techne said.

Apr 10, 2020

Active Motif Recombinant COVID-19 Antibodies

Active Motif said that in February it successfully isolated antibodies from patients in China recovering from COVID-19, and that the full suite of antibodies is now available for research applications and diagnostic test development. In collaboration with Fudan University and its Public Health Clinical Center, the company used its proprietary single-cell AbEpic screening technology to isolate the antibodies from patients, whose samples were screened to obtain whole human IgG antibody clones that have been sequenced, expressed, and characterized for binding directly to the SARS-CoV-2 S1 protein.

Apr 10, 2020

Codex Synthetic DNA Products for COVID-19 Research; Dx/Vaccine Development

Codex has launched a number of newly developed products and services for COVID-19 research and diagnostic/vaccine development. The new products include:

  • SARS-CoV-2 diagnostic RNA controls: safe positive controls that replace the need for live virus in RT-PCR and NGS testing protocols
  • SARS-CoV-2 antigen panels and antibody libraries: allow for rapid design and iteration of antigens or antibody libraries for the development of vaccines and therapeutics using the company's BioXp 3200 gene automated synthesis platform.
  • SARS-CoV-2 spike protein DNA vaccine construct, mRNA vaccine scaffold, and live attenuated vaccine scaffold for vaccine development
  • SARS-CoV-2 synthetic DNA parts: span the whole genome and useful for developing DNA, RNA, and viral vector vaccines and pan-genome diagnostics
  • SARS-CoV-2 full-length synthetic genome: the Wuhan-Hu-1 strain of SARS-CoV-2 cloned in a bacterial artificial chromosome for the development of vaccines, therapeutics, and diagnostics.
Apr 06, 2020

Verichem Laboratories: Enzyme ER Verifier Kits

Verichem Laboratories launched the Enzyme ER Verifier Kits, a ready-to-use, liquid stable product for the calibration verification of wet chemistry testing systems. The kit is a multianalyte, six-layer verifier kit of liquid stable materials. It comprises nine separate clinical enzyme components and covers 54 individual activities.

Apr 03, 2020

AmpTec Universal COVID-19 Positive Control IVT RNA EURM-019

AmpTec has released a Universal COVID-19 Positive Control IVT RNA, called EURM-019, to facilitate quality control of the detection of SARS-CoV-2 at core facilities and hospital laboratories. The EURM-019 material consists of single-stranded RNA fragments of the SARS-CoV-2 genome and can also serve as a benchmark to validate SARS-CoV-2 RT-PCR tests kits in development. AmpTec is supplying the control on behalf of the European Commission.

Apr 03, 2020

Thermo Fisher Scientific AcroMetrix Coronavirus 2019 (COVID-19) RNA Control

Thermo Fisher Scientific has launched the Thermo Scientific AcroMetrix Coronavirus 2019 (COVID-19) RNA Control to help validate and monitor COVID-19 molecular diagnostic tests. The non-infectious positive control consists of synthetic RNA transcripts containing the N, S, E, and Orf1ab regions of the SARS-CoV-2 genome. The RNA is ready for reverse transcription, PCR amplification, and detection. The kit contains two vials of RNA at concentrations that will result in low-positive and ultra-low-positive results in most commonly used PCR-based testing methods. The control is available globally as a research-use-only product and is not intended for clinical use.

Apr 03, 2020

Agilent K6460S Clinical Edition TQ LC/MS System

Agilent this week launched the K6460S Clinical Edition TQ LC/MS system, a triple quadrupole liquid chromatography/mass spectrometry system designed to improve in vitro diagnostic workflows in clinical labs. The system is listed as a Class I medical device with the US Food and Drug Administration and includes the clinical edition of Agilent MassHunter software to enable an easy and intuitive submission-to-reporting workflow. TQ LC/MS increases the specificity, selectivity, and accuracy of many clinical diagnostic assays compared to traditional binding assays, Agilent noted in a statement. The platform also received approval from China's National Medical Products Administration in January.

Apr 03, 2020

SensID Control Materials for Qiagen Therascreen PIK3CA RGQ PCR Kits

SensID, a Germany-based provider of controls and reference materials for clinical genomics, has introduced a set of controls for Qiagen's US Food and Drug Administration-approved and CE-IVD marked Therascreen PIK3CA RGQ PCR kits. Qiagen's kit was launched in Europe in February 2020 to aid in the identification of activating PIK3CA mutations in FFPE or blood plasma samples from patients with advanced breast cancer. The kit received FDA approval in 2019 and has been commercialized in the US as a companion diagnostic test for alpelisib (Novartis' Piqray).

SensID and Qiagen collaborated to develop the new control materials, which include 11 clinically actionable PIK3CA mutations estimated to be present in approximately 40 percent of HR+/HER2- advanced breast cancer cases and to confer a greater likelihood of responding positively to PI3K inhibitors. The control set contains seven vials (DNA in buffer) in a format matched to the reaction mixes of the Therascreen kit, and each set provides sufficient materials for about 40 runs, the company said. SensID also offers certified DNA-free human plasma that can be used in conjunction with the sample set, if suitable plasma is not available locally.

Mar 30, 2020

Viracor Eurofins [email protected]

Viracor Eurofins has launched [email protected], a mobile phlebotomy service for specimen collection for post-transplant testing directly from patients' homes. The firm said that during the coronavirus pandemic, bone marrow transplant and solid organ transplant patients may not be able to return to the hospital for routine and specialized post-transplant testing and management. Through the [email protected] service, physicians can order and customize a limited menu of infectious disease and transplant-related testing. A phlebotomist will work with the patient on specimen collection at the patient's residence. Options include PCR-based tests, therapeutic drug monitoring, CMV T cell immunity panel, Viracor's Transplant Rejection Allograft Check, and TruGraf Blood Gene Expression Test. 

Mar 20, 2020

Asuragen Armored RNA Quant SARS-CoV-2 Control

Asuragen is offering an Armored RNA Quant SARS-CoV-2 Control for use in developing assays in response to the COVID-19 pandemic. The new control material targets the SARS-CoV-2 viral nucleocapsid region and, along with the company's new RNAse P construct, aligns with the US Centers for Disease Control and Prevention- and World Health Organization-recommended diagnostic panel. Asuragen said that armored technology encapsulates the in vitro transcribed RNA in a protective protein coat to resist nuclease degradation, enabling its use as RNA extraction, process quality, and positive diagnostic reference controls.

Mar 20, 2020

LGC SeraCare AccuPlex SARS-CoV-2 Reference Material Kit

LGC SeraCare recently launched the AccuPlex SARS-CoV-2 Reference Material Kit, which contains positive reference material targeting the published US Centers for Disease Control and Prevention and World Health Organization consensus sequences, as well as complementary negative reference material targeting the human RNAse P gene. LGC SeraCare said that its kit is superior to "naked" transcribed RNA which does not evaluate the assay extraction step, and safer than heat-treated infectious samples, and are a valuable tool for clinical laboratories seeking to perform assay installation, verification, and performance monitoring.

Mar 17, 2020

CareDx RemoTraC

To address the concerns of the immunosuppressed transplant community to the COVID-19 pandemic, CareDx has launched RemoTraC, a solution enabling remote home-based monitoring of transplant patients. RemoTraC is a remote home-based blood draw product that uses mobile phlebotomy for AlloSure and AlloMap surveillance tests, as well as for other standard monitoring tests.

RemoTraC will be offered to all patients who want their transplant monitoring lab tests to be drawn at home by trained mobile phlebotomists, CareDx said. The company has built a national network of blood draw options for the transplant community. Patients can register through the web.

Mar 13, 2020

Bio-Rad Exact Diagnostics SARS CoV-2 Standard

Bio-Rad has launched a standard for SARS-CoV-2 testing through its Exact Diagnostics product line. The standard contains synthetic RNA transcripts of the virus as well as human genomic DNA, enabling labs to test the entire process of a molecular assay, including extraction, amplification, and detection of the virus.

Mar 13, 2020

Microbiologics Synthetic RNA for SARS-CoV-2

Microbiologics is now offering synthetic RNA for SARS-CoV-2 to assist in the efforts to monitor the spread of COVID-19. The material mimics the viral nucleic acid and provides the exact targets specified by the US Centers for Disease Control and Prevention for test development, the company said.

Specifically, it is a 1,044-nucleotide RNA specific for the SARS-CoV-2 N (nucleocapsid) gene. It contains all three markers (N1, N2 and N3) detected by the CDC Real-Time RT PCR Panel for detection of 2019 novel coronavirus. The RNA material assists in the development of diagnostic assays and the evaluation of the performance of nucleic acid tests for determination of the presence of SARS-COV-2.

The RNA is available in two different concentrations: 1x106 and 1x109 genome copies per tube. The material can be shipped within the USA without handling restrictions or permitting requirements. The company noted that permits may be required outside the USA and interested parties should check with local authorities.

Mar 12, 2020

Twist Bioscience Synthetic SARS-CoV-2 RNA Controls

Twist Bioscience has made two synthetic SARS-CoV-2 RNA controls available for use in quality control in the development and validation of next-generation sequencing- and reverse-transcription PCR-based tests.

The sequence-verified controls are designed to cover the full viral genome of two specific virus variants: MN908947.3, considered the reference genome, isolated from a patient in Wuhan, China, and MT007544.1, isolated from a patient in Australia.

Twist noted that customers purchasing synthetic controls are subject to the firm's biosecurity screening protocols.

Mar 11, 2020

ZeptoMetrix NATtrol SARS-CoV-2 Recombinant Construct

ZeptoMetrix has released its newly inactivated and non-infectious NATtrol SARS-CoV-2 Recombinant construct for laboratory quality control and test validation.

This non-infectious quality control incorporates a recombinant construct associated with targeted detection regions of the virus that may be used in the development of molecular assays designed to detect SARS-CoV-2. It can also be used in BSL-2 facilities in place of the live virus, as non-infectious, external quality controls for assays developed to detect SARS-CoV-2, the company said.

Mar 10, 2020

Instrumentation Laboratory GEM Premier ChemStat IVD Analyzer

Instrumentation Laboratory has launched its GEM Premier ChemStat in vitro diagnostic analyzer with Intelligent Quality Management (iQM) in the US. The whole-blood analzyer is designed for rapid metabolic panel testing at the point of care, primarily in hospital emegency departments and clinical laboratories, and provides laboratory-quality results on demand in less than 70 seconds from venous or arterial lithium-heparinized, whole-blood samples. iQM provides information about the quality of each sample and automatically detects, corrects, and documents any action the system performs, ensuring test quality and supporting immediate patient management decisions. 

Mar 10, 2020

Thermo Fisher Cascadion SM 25-OH Vitamin D Assay

Thermo Fisher announced its Cascadion SM Clinical Analyzer is commercially available in the US with the Cascadion SM 25-Hydroxy Vitamin D assay. The serum assay reports total vitamin D results alongside its components and is designed to deliver measurements of vitamin D2 (ergocalciferol) and D3 (cholecalciferol). The test incorporates fully barcoded components, and the calibrators and controls are traceable according to the National Institute of Standards and Technology. Assay calibration remains stable for up to 30 days, the company said. Both the analyzer and the assay were listed with the US Food and Drug Administration on Feb. 28, 2020. The analyzer is listed as a Class I instrument, and the assay is listed as Class II exempt with special controls. 

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