New Products

Feb 13, 2018

SeraCare Seraseq Breast CNV; Lung and Brain CNV Mix

SeraCare Life Sciences launched the Seraseq Breast CNV and Seraseq Lung and Brain CNV Mix, reference materials for analyzing copy number variation. Both have been built with biosynthetic technology that can be easily scalable to incorporate new CNVs over time, and were developed so that clinical labs conducting NGS-based tumor profiling for cancer can better understand and characterize their assays, SeraCare said. They were precisely quantified using highly sensitive digital PCR assays to analyze amplification of EGFR, MET, FGFR3, MYC, ERBB2, and MYCN genes at +3, +6, and +12 copies against a single well-characterized genomic background, the company said.

Feb 09, 2018

Sema4 Natalis

Sema4 has launched Natalis, a supplemental newborn screening test designed to detect 193 childhood-onset diseases or disorders. In the US, newborns are typically screened for 34 health conditions on the recommended uniform screening panel, but the conditions vary by state and represent only a fraction of the genetic diseases that can manifest in a child's first decade, Sema4 noted. As a supplemental test, Natalis screens for more than five times the number of genetic diseases than a state's standard hospital test, the company said. Every Sema4 Natalis order also includes a pharmacogenetic analysis of how a baby is likely to respond to 38 medications commonly prescribed at an early age. The test uses DNA sequencing analysis, and sample collection can be performed at home with a cheek swab, the company said.

Feb 06, 2018

Laboratorio Noy Oncocyst PD-L1

Laboratorio Noy launched the Oncocyst PD-L1 test, which uses IncellDx technology to quantify the percentage of abnormal bladder cells and immune cells from urine cytology samples expressing PD-L1. The assay also detects aneuploidy in cells from the bladder. The high-throughput assay is non-subjective and can be performed in less than three hours, Laboratorio Noy said. 

Feb 06, 2018

Personalis ImmunogenomicsID and NeoantigenID

Personalis has launched ImmunogenomicsID, which combines DNA and RNA sequencing data to generate an immunogenomic profile of a tumor and its microenvironment. The product is designed to help identify biomarkers and signatures that can impact patient response to cancer immunotherapies. It is a new component and extension of the company's existing ACE ImmunoID Platform, which combines genome-scale sequencing with data analytics for broad tumor immunogenomic characterization.  

The company also announced the latest release of NeoantigenID, a component of the ACE ImmunoID platform. ACE ImmunoID, which uses Personalis' patented ACE technology, combines augmented exome and transcriptome sequencing with analytics to enable broad tumor immunogenomic characterization. This newest release of NeoantigenID not only identifies candidate neoantigens derived from single nucleotide variants, but now also includes putative neoantigens derived from insertion and deletion mutations and gene fusions, for both MHC Class I and Class II, the company said. The new analytics integrate DNA and RNA sequencing data to calculate neoantigen load, expression of genes, and expression of variants, while incorporating phasing information to improve the accuracy of neoantigen prediction.

Feb 02, 2018

Lucence Diagnostics Plasma EGFR C797S Mutation Detection Assay

Lucence Diagnostics has launched its plasma EGFR C797S non-invasive mutation detection assay for clinical use in Southeast Asia. The assay is based on Lucence's proprietary Lumi-ARMS technology, and rapidly detects the presence of the EGFR C797S mutation which is linked with osimertinib resistance in EGFR-mutant non-small cell lung cancer. The assay can be used with blood and cerebrospinal fluid and features a sensitivity of up to 0.01 percent, the company said. The assay is also currently available as part of the Lucence LiquidTrack test offered through the company's reference laboratory in Singapore.

Feb 01, 2018

OpGen Acuitas Gene Panel u.547 Test

OpGen has announced today the commercial availability of its Acuitas AMR Gene Panel u5.47 test. The research-use-only test was developed to detect the most common bacterial causes of complicated urinary tract infections from urine and isolated colonies. The gene panel also detects 47 gene targets that indicate antibiotic resistance. Test results are typically available in less than three hours compared to traditional microbiology methods, which require two to three days to produce results. 

Jan 30, 2018

PerkinElmer GSP Neonatal Creatine Kinase – MM (CK-MM) kit

PerkinElmer launched the GSP Neonatal Creatine Kinase –MM (CK-MM) kit, a screening kit for Duchenne muscular dystrophy, which is a progressive X-chromosome linked neuromuscular disorder with a worldwide average incidence rate of approximately 1 in 5,000 male live births. The kit is an immunoassay for measuring CK-MM in newborn babies' dried blood spot samples. The company says the assay is the first commercially available in-vitro diagnostic kit for newborn screening of Duchenne muscular dystrophy. Previously the only available alternative for biochemical assessment of CK levels in dried blood spot samples for newborn screening consisted of non-standardized lab developed tests based on CK enzyme activity measurement, according to the company.

Jan 26, 2018

Sciex Diagnostics Citrine Triple Quad MS/MS, Citrine QTrap MS/MS systems

Sciex Diagnostics launched the Citrine Triple Quad MS/MS and Citrine QTrap MS/MS systems for clinical diagnostics. The Citrine platform was designed for clinical labs that need maximum sensitiviity, high-throughput, a wide dynamic range, and the ability to use a simplified sample preparation, Sciex said. It added that the system offers electrospray ionization and atmospheric ionization options, an extended mass range up to m/z 2,000, and a wide linear dynamic range. 

Jan 24, 2018

Sophia Genetics AI

Sophia Genetics said this week that its Sophia AI platform now has radiomics capabilities, which will be combined with the technology's existing genomic analysis capabilties. The new capabilities are based on mechanistic and mathematical modelling and help to predict the evolution of a tumor (size, volume, and location) by analyzing quantitative image features from two or more consecutive standard-of-care medical images (i.e. PET-scans, MRIs, x-rays and more). Clinical proofs of concept have already been executed on hundreds of patients' cases for lung, kidney, glioma, and meningioma, and the technology should soon be applied to any solid tumor, the company said.

Jan 22, 2018

Enzo Biochem p16

Enzo Biochem launched its p16 cervical cancer biomarker detection test. The test, the firm said, is the latest addition to its immunohistochemistry pipeline, which includes Ki-67, HER2, and p53. The validated p16 test allows for the detection of tissue abnormalities in cancer, including cervical cancer, and it complements Enzo Biochem's Polyview line of immunohistochemistry detection products, the company said. 

Jan 17, 2018

PerkinElmer NeoBase 2 non-derivatized MSMS Kit

PerkinElmer has launched its NeoBase 2 non-derivatized MSMS Kit, which received CE marking early last month. The IVD kit is intended for the semiquantitative measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside, and lysophospholipid concentrations. It is for analzying newborn heel prick samples dried on filter paper and is used with a tandem mass spectrometer. The kit can be used to test up to 57 analytes, including markers for screening X-linked adrenoleukodystrophy, as well as adenosine deaminase severe combined immunodeficiency. 

Jan 17, 2018

Cancer Genetics Complete::IO Immuno-Oncology Panel

Cancer Genetics has expanded its immuno-oncology panel, Complete::IO, to include five new markers, bringing the total to 27. The test is a multi-marker panel for characterization of the immune repertoire of cancer patients, including circulating immune cell populations and the tumor microenvironment.

The assay is designed to help identify patients who are likely to respond to specific therapies, as well as to monitor and stratify patient populations during clinical trials. The five new markers now allow the test to detect myeloid-derived suppressor cells, as well as those that express PD-1, PD-L1, or PD-L2.

Jan 12, 2018

Castle Biosciences DecisionDx-UMSeq Panel

Castle Biosciences has launched the DecisionDx-UMSeq panel, which uses next-generation sequencing to identify somatic mutations in genes relevant to uveal melanoma. The panel will evaluate DNA mutations in seven genes known to be relevant to UM: GNAQ, GNA11, PLCB4, CYSLTR2, SF3B1, exons 1-2 of EIF1AX, and coding exons of BAP1. While no currently available therapies target pathways affected by the gene mutations evaluated in the panel, the genomic information may be useful in the future to inform patient care as UM research and therapeutic options evolve, the company noted. The assay will complement Castle's DecisionDx-UM gene expression profile test for assessing likelihood of metastasis in UM.

Jan 10, 2018

Thermo Fisher Scientific Ion Torrent Oncomine Pan-Cancer Cell-Free and Tumor Mutation Load Assays

Thermo Fisher Scientific has launched two new Oncomine assays. The Ion Torrent Oncomine Pan-Cancer Cell-Free Assay is designed for the analysis of tumor DNA and RNA for all major classes of mutations. The assay, which targets more than 50 genes across multiple tumor types, including lung, colorectal, breast, pancreatic, and thyroid cancer, requires a single vial of blood and as little as 1 nanogram of nucleic acid input material and can be completed in two days. The Ion Torrent Oncomine Mutation Load Assay sequences 409 genes using as little as 20 nanograms of DNA from formalin-fixed paraffin-embedded tissue. It is designed to improve selection strategies for immunoherapy clinical trials.

Jan 05, 2018

Roche Plasma Separation Card

Roche announced the launch of the Cobas Plasma Separation Card, a sample collection device for HIV plasma viral load testing. By providing a small amount of a patient’s blood from a fingertip, the specially designed card simplifies blood collection and sample transportation, Roche said. 

The card allows for reliable quantitative testing of patients with HIV living in remote areas while meeting World Health Organization requirements for determining HIV viral load prior to setting treatment.

Jan 04, 2018

Beckman Coulter Syva Emit II Plus 6-AM, Syva Emit II Plus BUP

Beckman Coulter Diagnostics made available the Syva Emit II Plus 6-AM and Syva Emit II Plus BUP assay for drug-of-abuse screenings. The Syva Emit II Plus 6-AM assay is for screening heroin use. According to Beckman Coulter, it offers a more convenient and quicker method than alternative methods such as gas chromatography or mass spectrometry. It minimizes false positives by demonstrating no cross-reactivity to morphine, morphine metabolites, and common analgesics.

The Syva Emit II Plus BUP assay is intended for the qualitative and/or semi-quantitative analysis of buprenorphine in human urine. Its high specificity for buprenorphine and norbuprenorphine minimizes false positives, and does not cross-react with commonly abused opiates, according to Beckman Coulter.

Jan 03, 2018

Mobidiag Novodiag

Mobidiag launched the Novodiag, a fully automated solution for syndromic and targeted testing for infectious disease. Novodiag allows direct analysis of a patient sample in a disposable cartridge and delivers results in a few hours, according to the firm. It also allows for the detection of antibiotic resistance. The PCR and microarray-based instrument is aimed at small- to medium-sized clinical microbiology labs with lower throughput requirements. 

Dec 21, 2017

Inova Diagnostics Immunoassay Processor

Inova Diagnostics announced the global launch of Quanta-Lyser 3000, a fully automated enzyme linked immunoassay (EIA) and immunofluorescence assay (IFA) processor for use in the clinical laboratory.  

Existing methods for EIA and IFA testing used in many laboratories are time- and labor-intensive and prone to transcription errors. Inova said that its processor addresses many shortcomings of manual EIA and IFA processing. 

The firm said that its product's 240-capacity sample deck reduces the number of daily interventions, and four independently operating probes provide fast turnaround time. The washable probes eliminate the need for costly disposable tips, the firm said.

Dec 19, 2017

Ortho Clinical Diagnostics Alanine Aminotransferase Technology

Ortho Clinical Diagnostics announced the launch of Vitros ALTV Slides, a method that uses dry slide technology for the measurement of alanine aminotransferase (ALT), a key liver function enzyme found in serum and plasma. 

ALT is used in the diagnosis and treatment of heart diseases and certain liver diseases, such as viral hepatitis and cirrhosis. Due to its distribution primarily in the liver, elevated ALT levels are highly suggestive of liver damage, and ALT measurements are particularly useful in the diagnosis and management of liver disease, Ortho said.

Dec 14, 2017

Paradigm Diagnostics PCDx Tests

Paradigm Diagnostics said that all of its Paradigm Cancer Diagnostic (PCDx) tests ordered for lung cancer patients now also include 17 fusions, as well as EGFR and MET skipping events. The fusions include: ALK, AXL, BRAF, CCND1, FGFR1, FGFR2, FGFR3, MET, NGR1, NTRK1, NTRK2, NTRK3, PPARG, RAF1, RET, ROS1 and THADA. The fusion panel may also be ordered as an add-on for any PCDx patients and will be delivered within in the company's standard five-day turnaround time. The assay uses anchored PCR technology on RNA to detect known and novel fusions with high sensitivity with a tissue requirement of 4 percent or greater tumor content in a single core needle biopsy or fine needle aspirate.

Dec 06, 2017

Sygnis TruePrime Apoptotic Cell-Free DNA Amplification Kit

Sygnis has launched the TruePrime apoptotic cell-free DNA amplification kit under the Expedeon brand. The kit enables accurate DNA amplification using cell-free DNA from plasma, serum, urine, cerebrospinal fluid, and other bodily fluids. The kit uses a multiple displacement amplification method to overcome common limitations of cell-free DNA analysis of such fluids, Sygnis said, adding it provides users with "excellent sensitivity, error-free amplification in hih yields, and a streamlined workflow for reduced hands-on time." 

Dec 01, 2017

OncoDNA's OncoSelect

Belgian biotech firm OncoDNA has launched OncoSelect, an assay for circulating tumor DNA in blood samples from non-small cell lung cancer, colon cancer, or breast cancer (ER+ or HER2+) patients. OncoSelect assays for more than 100 mutatioons of resistance and sensitivity to targeted therapies. To monitor progression of cancer, the test should ideally be performed midway through treatment and two weeks after the last does, the company said. Turnaround time from receipt of sample to issuance of a full report to the treating oncologist is seven working days.

Nov 29, 2017

Sonora Quest Laboratories Solid Tumor NGS Test

Sonora Quest Laboratories has launched a next-generation sequencing test for solid tumors. It targets 52 genes and is based on the ThermoFisher Scientific Oncomine Focus Assay. The test analyzes DNA and RNA concurrently and detects different types of mutations, including copy number variants and gene fusions.

Nov 16, 2017

True Health Respiratory Pathogen Screening

True Health launched the respiratory pathogen screening, a single test that targets 21 viral and bacterial pathogens to help clinicians determine the correct treatment for respiratory illnesses during cold and flu season. True Health's program is built to identify the specific cause of the infection so clinicians can prescribe an effective treatment. The 21-pathogen screen has a one day turn around from receipt of the specimen at the lab to delivering the results. The screen is conducted using multiplex PCR.

Nov 15, 2017

Circulogene Microsatellite Instability Biomarker Testing

Circulogene announced the availability of microsatellite instability biomarker testing for multiple cancer types. The test is immediately available to oncologists and pathologists, enabling them to identify patients eligible for treatment with Keytruda (pembrolizumab) across multiple cancer types, or Opdivo (nivolumab) for colorectal cancer. With the new assay, Circulogene now provides circulating DNA, RNA, and MSI cancer immunotherapy testing from a single tube of blood with a three-day turnaround time out of it CLIA-certified laboratory.