Close Menu

Codexis enzymes for NGS-, PCR-based MDx applications

Jan 06, 2017
Codexis is offering high-performance enzymes to customers using NGS and PCR/qPCR for in vitro molecular diagnostic applications. Its first proprietary enzyme will target improved libarary preparation for NGS uses and is anticipated to be available in bet-test format in the second quarter. 

More Like This

Oct 11, 2019

Sema4 Expanded Carrier Screening

Sema4 has launched a larger Expanded Carrier Screen for family planning with personalized residual risk.

The test analyzes 502 genes associated with clinically relevant conditions, up from 283 genes, to cover more rare diseases. The test detects more high-risk pregnancies and identifies up to 30 times more carrier couples, Sema4 CEO Eric Schadt said in a statement. It also incorporates low-pass genome analysis to detect ancestry markers that to refine the accuracy of results.

Oct 10, 2019

Predictive Laboratories ARTguide Test

Salt Lake City, Utah-based Predictive Laboratories has commercially launched its ARTguide DNA-based blood test, which examines the risk for endometriosis and other genetic causes of infertility in women. According to the firm, the test identifies hundreds of genetic markers of endometriosis and 80 other additional mutations causing conditions that may impact fertility.  

Oct 10, 2019

Co-Diagnostics Vector Smart ZDC Test

Co-Diagnostics has commercially launched its Vector Smart ZDC test, which is used to identify the presence of Zika, dengue, and chikungunya in mosquito populations. The firm said that its line of Vector Smart PCR products are validated using extractions from mosquito samples to reduce the possibility of a false negative result due to improper extraction. 

Oct 01, 2019

NanoString nCounter Human Organ Transplant Panel

NanoString Technologies has launched its nCounter Human Organ Transplant panel, a new gene expression panel for evaluating the immune response following organ transplantation. The firm said that it created the assay in collaboration with the Banff Foundation for Allograft Pathology. The panel covers 770 genes and is customizable. It is designed for use with the predominant transplant organs including kidney, heart, lung, and liver. Genes included on the panel are involved in 37 pathways that are components of the immune response, tissue injury, and mechanisms of action for immunosuppressive drugs. The panel also includes probes to detect common viral infections that can cause issues with transplants, including BK polyomavirus, cytomegalovirus, and Epstein-Barr virus.

Oct 01, 2019

Ambry Genetics +RNAinsight

Ambry Genetics has launched +RNAinsight, a combined DNA and RNA genetic test for hereditary cancer syndromes that is designed to return more certain results to patients by using RNA sequencing to definitively classify otherwise ambiguous genetic alterations. While the RNA aspect of the test does not include all known cancer risk genes, it does focus on a subset that includes BRCA1 and 2, TP53, PTEN, and PALB2, among others. Ambry said that the turnaround time for the combined test matches the company's DNA-only hereditary cancer panel.

Sep 30, 2019

T2 Biosystems T2Resistance Panel

The T2 Biosystems T2Resistance Panel for genotypic antibiotic resistance marker testing is now available as a research use only test in the US. The panel uses the firm's T2Dx instrument and identifies 13 genes conferring resistance to common empiric antibiotic therapies, such as carbapenems, vancomycin, and penicillin, directly from whole blood within three to five hours. The panel received breakthrough device designation from the US Food and Drug Administration earlier this year and is on track to receive CE mark by the end of 2019.

Sep 30, 2019

HiberGene Diagnostics HG RSV A/B Combo Test

HiberGene Diagnostics has launched its HG RSV A/B Combo test, which uses nasopharyngeal swabs for the direct detection of the respiratory syncytial virus in less than 60 minutes. HiberGene said its multiplexing technology delivers a differential diagnosis between A and B subtypes to facilitate best treatment options.

The RSV product brings to 10 the number of tests that can be used with HiberGene’s lightweight HG Swift analyzer. The HiberGene product menu spans hospital-acquired infections, sexually transmitted diseases, and critical infectious diseases, and the tests are suitable for use in near-patient settings.

Sep 25, 2019

Roche Cobas EBV, BKV Tests

Roche has launched the Cobas EBV and BKV tests for Epstein-Barr virus and BK virus in countries accepting the CE mark. The tests are for use with Roche's Cobas 6800/8800 Systems. The real-time PCR tests leverages dual target technology help clinicians manage the risk of infection for severely immunocompromised transplant patients and assess if these patients are at risk of of developing disease, which can contribute to organ rejection, the company said. 

Sep 19, 2019

Instrumentation Laboratory HemosIL AcuStar ADAMTS13 Activity Assay

Instrumentation Laboratory has launched the HemosIL AcuStar ADAMTS13 Activity Assay in the EU and other international markets. The assay is for use with the ACL AcuStar Hemostasis Testing System. The fully automated, chemiluminescent immunoassay provides clinicians rapid, on-demand ADAMTS13 activity testing for aid in diagnosing and monitoring thrombotic thrombocytopenic purpura. First results can be obtained in about 30 minutes, Instrumentation Laboratory said. 

Sep 18, 2019

Yourgene Elucigene DPYD

UK-based Yourgene has launched the Elucigene DPYD assay, a CE-marked chemotoxicity diagnostic test that uses genotyping to identify cancer patients with dihydropyrimidine dehydrogenase (DPD) deficiency. The deficiency causes several and sometimes lethal side effects in patients treated with 5-fluorouracil (5-FU), which is metabolized by the DPD enzyme, encoded by the DPYD gene. Elucigene DPYD, which tests for six common genetic variations, conforms with Clinical Pharmacogenetics Consortium guidelines, which recommend testing for four clinically relevant mutations.

Sep 04, 2019

Xifin LIS 6

Xifin has introduced a new version of its laboratory information system, Xifin LIS 6. The latest iteration of the software-as-a-service platform includes several features resulting from recently formed partnerships. Notably, Xifin LIS 6 includes artificial intellegence-driven genomic data interpretation, thanks to a partnership with Fabric Genomics. The new release supports fast, scaleable analysis of next-generation sequencing to produce "physician-ready" clinical reports, the company said.  

Other upgrades in LIS 6 include support for digital pathology workflows via a collaboration with Proscia, integration of Glidian's automated prior authorization technology, and access to test utilization support from the Medical Database LDS laborator decsion system.

Aug 26, 2019

Aria Diagnostics: SynCheck

Aria Diagnostics has launched SynCheck for detecting synthetic and adulterated urine. The Indianapolis-based company said the test can be used for opioid-use detection, and it will provide SynCheck to physicians and rehab centers for free. 

Aug 07, 2019

OmniPathology FISH test for HPV-related cancer

OmniPathology has announced a new fluorescence in situ hybridization test to detect human papilloma virus (HPV)-related cancer.

The test detects fluorescent-labeled DNA probes bound to the TERC gene locus at chromosome location 3q26. It can be used for early detection of malignant and premalignant conditions in both male and female patients.

Aug 05, 2019

PerkinElmer Euroimmun Aspergillus Antigen ELISA

PerkinElmer has launched the Euroimmun Aspergillus Antigen ELISA for detection of the Aspergillus antigen galactomannoprotein and aid in distinguishing invasive apergillosis. Eurommun CEO Wolfgang Schlumberger said in a statement that when processed using the automated Euroimmun Analyzer system, the Euroimmun Aspergillus Antigen ELISA "seamlessly" integrates into a lab workflow, resulting in quicker detection of Aspergillus infections at an earlier stage. Euroimmun is a PerkinElmer company.

Jul 31, 2019

Mesa Biotech RSV

San Diego, California-based molecular diagnostics developer Mesa Biotech has launched a respiratory syncytial virus test on its sample-to-answer point-of-care PCR system, the Acula. The RSV test is the second test on the system, which also runs an influenza A/B test and is exclusively marketed in the US by Sekisui under the Silaris brand. It was cleared by the US Food and Drug Administration and CLIA-waived last year for diagnostic use in both children and adults.