Oxford Gene Technology Cytocell Aquarius FISH Probes for Sarcoma

Dec 15, 2016

Oxford Gene Technology has launched three new Cytocell Aquarius FISH probes for pathology. The FUS Breakapart and FOXO1 Breakapart probes are CE-IVD marked. The TFE3 Breakapart probe is for research-use only, the company said. 

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Jul 19, 2017

LabCorp ADAMTS13 Test

Laboratory Corporation of America began offering the ADAMTS13 test for a rare life-threatening blood-clotting disorder. The test distinguishes diseases characterized by acute thrombotic microangiopathy (TMA), a relatively rare syndrome in which small blood vessels develop blood clots. The test can provide faster and more accurate results, compared to other tests, to rule in or out the diagnosis of thrombotic thrombocytopenia purpura, a condition that can cuase TMA, and to support decisions whether to start patients on certain therapies, LabCorp said. The test is run on liquid chromatography-tandem mass spectrometry technology.

Jul 19, 2017

Quest Diagnostics QHerit Screening Service

Quest Diagnostic launched QHerit, a genetic screening service that tells individuals their risk of passing on heritable disorders to future generations. The QHerit Pan-Ethnic Expanded Carrier Screen provides information for 22 heritable diseases cited under new screening guidelines issued earlier this year by the American College of Gynecology. In addition to more well-known heritable disorders such as cystic fibrosis and sickle cell disease, QHerit also identifies lesser-known mutations associated with Joubert Syndrome 2 and fragile X syndrome. It also screens for spinal muscular atrophy and includes the evaluation of hemoglobinopathies.

Jul 18, 2017

BD Kiestra Urine Culture App

Becton Dickinson has introduced technology that can automatically report and release negative urine cultures. The firm has introduced the BD Kiestra urine culture app, which uses digital imaging and software algorithms to determine the amount of growth on a urine culture plate from clean caught and catheterized samples, when it is used along with BD BBL plated media. Using the BD Kiestra ReadA Compact's intelligent incubation and imaging device with high-throughput robotics to perform time series imaging, the system can automatically release plates with no significant growth for disposal, and the results are reported to the customer's compatible laboratory information system. Plates with significant growth automatically go into a queue for clinician analysis.

Jul 14, 2017


The University of California, San Francisco's Center for Next-Gen Precision Diagnostics has launched a metagenomic next-generation sequencing test for neurological infections. Physicians can order the test for patients with idiopathic meningitis or encephalitis with unknown etiology. Testing is performed on cerebrospinal fluid. The testing process takes around 72 hours and results are reported back within one to two weeks. Charles Chiu, director of UCSF's Viral Diagnostics and Discovery Center, most recently described the test at a conference in February.

Jul 14, 2017

Biocept Progesterone Receptor Liquid Biopsy Test

Biocept has announced the commercial availability of its liquid biopsy test for progesterone receptor (PR), which can be used for the detection and monitoring of a key biomarker in the blood of patients with breast cancer. The company noted that the ability to detect PR expression in circulating tumor cells complements its existing ER and HER2 assays for biomarker analysis in breast cancer. Biocept's Target Selector PR expression test is performed on circulating tumor cells using fluorescently labeled antibodies. The company's liquid biopsy tests are performed in its CLIA-certified, CAP-accredited laboratory in San Diego.

Jul 12, 2017

Exact Diagnostics Verification Panels

Exact Diagnostics launched its verification panels for IVD use. The panels include adenovirus; BKV; CMV; EBV; HBV; HCV; HHV-6A; HHV-6B; HIV-1; HSV-1; HSV-2; VZV; and Zika. They can be used to establish reference points to measure various analytes in molecular assays, the firm said. 

Jul 11, 2017

Neolys Diagnostics Radiosensitivity Test

Neolys Diagnostics launched its blood test for measuring a patient's radiosensitivity before radiotherapy. With results in a few hours, the test can identify a patient's risk of having severe side effects from such therapy. The screening test is designed to be performed systematically for every patient. 

Jul 11, 2017

Sysmex America XN-L Hematology Analyzer

Sysmex America launched its XN-L automated hematology analyzers in the US. The new smaller instrument delivers the capabilities of its XN-Series of instruments to lower-volume hematology labs, and will be the first to feature BeyondCare Quality Monitor, the firm said.

Jun 29, 2017

HTG Molecular Diagnostics GEP Assay

HTG Molecular Diagnostics launched the EdgeSeq Path Assay in the US and Europe. The assay is designed for retrospective gene expression profiling to complement immunohistochemistry testing. It allows investigators to assess mRNA expression of large numbers of biomarkers when there's limited availability of formalin-fixed, paraffin-embedded samples.

Jun 28, 2017

Redbud Labs MXR

Redbud Labs released MXR, a microfluidic chip that accelerates molecular assay by as much as tenfold. Redbud said the chip is specifically designed for diagnostic consumables and can be added to almost any cartridge design. MXR is a microfluidic mixer that delivers rapid, gentle agitation that can improve reaction kinetics, decrease variability, and simplify cartridge design. 

Jun 28, 2017

Roche Harmony NIPT 22q11.2 Deletion

Roche has added 22q11.2 deletion testing to the Harmony Prenatal Test menu, allowing laboratories and physicians using the test to screen for 22q11.2 deletion syndrome, which is associated with heart defects, poor immune system function, cleft palate, and delayed development. The 22q11.2 deletion is estimated to occur in one out of every 2,000 to 4,000 live births.

Jun 26, 2017

Premaitha Health Updated Iona Test

Premaitha Health has updated its Iona noninvasive prenatal test, which now includes the first trimester combined test risk score as an option in its software. The company said that it completed a validation study to show that the Iona test in combination with the first trimester combined screen was as accurate as estimating prior risk using maternal age.

Jun 26, 2017

BloodCenter of Wisconsin's Diagnostic Laboratories hematology test panels

BloodCenter of Wisconsin's Diagnostic Laboratories launched seven hematology genetics test panels. The new panels include nonmalignant hematology disorders, such as platelet function disorders, inherited thrombocytopenia, and congenital neutropenias.  

Jun 22, 2017

Grifols TDMonitor assays

Grifols has launched a therapeutic drug monitoring testing service as part of its Texas-based clinical diagnostics laboratory menu. Its TDMonitor assays measure levels of infliximab, Humira (adalimumab), and Entyvio (vedolizumab) and the antidrug antibodies, and support therapeutic decisions by clinicians.

Jun 22, 2017

Quest Diagnostics Blueprint For Athletes

Quest Diagnostics has expanded the capabilities of its biomarker testing service called Blueprint for Athletes to include at-home specimen collection using the Mitra microsampling device, which uses a few drops of blood. The at-home collection sampling is available now for Blueprint for Athletes Hormone package and is expected to become available with other Blueprint for Athletes services later this year.

A Blueprint for Athletes "concierge collection" service also is available now, in which trained phlebotomists will go to a person's home to collect a blood specimen for testing. Blueprint for Athletes is based on medical-grade diagnostic tests and is subject to federal and state regulations. It is available in 33 states.