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Invitae Spinal Muscular Atrophy Test

Mar 22, 2017

Invitae launched a new genetic test for diagnosing spinal muscular atrophy (SMA), a neuromuscular disease that impacts infants' ability to walk, crawl, and eventually breath and swallow, and can be lethal. The company claims that its genetic test is an improvement over currently available methods. Affecting one in every 10,000 infants, SMA is an autosomal recessive disorder that is usually caused by the loss of SMN1 gene, while variations in the number of copies of SMN2 contributes to disease severity. Accurately gauging both sequence changes in SMN1 and copy number changes in SMN2 has been challenging in the past, but the company said in a statement it is hoping to address this with its next-generation sequencing test and customized bioinformatics solution. Invitae is offering analysis of SMN1 and SMN2 as a standalone test, and adding the genes to its neuromuscular and neuropathy panels.

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Apr 12, 2021

Interpace Pharma Solutions: RNAscope ISH

Interpace Pharma solutions, a subsidiary of Interpace Biosciences has launched its RNAscope in situ hybridization (ISH) assay. The firm said RNAscope ISH uses "double Z" probes that simultaneously offer signal amplification and background noise control. Single-molecule visualization of the assay produces quantitative RNA expression and cell-specific expression with tissue architecture. The firm said that RNAscope ISH can streamline immune checkpoint target identification, visualize in vivo delivery of CAR-T therapeutic products, and distinguish therapeutic gene sequence from endogenous transcripts selection. 

Apr 01, 2021

MatMaCorp MY Real-Time Analyzer

Lincoln, Nebraska-based Materials and Machines Corporation, also known as MatMaCorp, has launched a rapid handheld molecular testing instrument called MY Real-Time Analyzer, or MYRTA, that performs PCR amplification or isothermal amplification and simultaneous real-time fluorescence detection. The device weighs less than one pound, can be held in one hand during operation, and can detect DNA or RNA targets within one hour, according to MatMaCorp. MYRTA can also process one sample with up to three different tests, and provides near quantitative information, including a Ct value.

Mar 31, 2021

OptraScan, OS-Ultra 320 High-Speed Digital Pathology Scanner

Digital pathology firm OptraScan has launched the OS-Ultra 320 high-speed digital pathology scanner. The instrument scans tissues and cells of 15 x 15 mm at 40x magnification in under a minute and features no-touch continuous loading operation. The San Jose, California-based firm noted the OS-Ultra 320 has been developed to reduce workflow errors and scale up pathology laboratory operations.

Mar 30, 2021

Beckman Coulter SuperNova Polymer Dyes

Beckman Coulter Life Sciences launched its SuperNova polymer dyes for flow cytometry that offer increased brightness when excited by the violet laser for their respective channel, allowing for clearer differentiation between positive and negative results for dimly expressed markers. The dyes also have an improved staining index through a proprietary formulation using unique additives to minimize non-specific staining for clearer results. They can help eliminate false positives and reduce re-testing due to unclear results, the company said.

Mar 23, 2021

Biocartis Idylla GeneFusion Assay

Biocartis has launched its Idylla GeneFusion Assay. The firm said the research-use-only test analyzes a wide range of biomarkers covering all gene fusions considered to be relevant in cancer research, including ALK, ROS1, RET, NTRK1/2/3 fusions, and MET exon 14 skipping mutations. Biocartis' test, which produces results within three hours, is the first formalin-fixed, paraffin-embedded RNA-based assay on Biocartis' Idylla platform. 

Mar 19, 2021

Grifols: Promonitor Quick Immunoassays

Grifols has launched a two-test point-of-care system to monitor levels of infliximab, a medication used to treat a variety of chronic inflammatory conditions. The rapid POC tests, part of Grifols' Promonitor Quick immunoassays, deliver results in 20 minutes using a fingerstick of whole blood. Promonitor Quick leverages lateral flow immunochromatography and eliminates pre-analytical sample processing. It is portable and enables clinicians and laboratory staff to measure levels of infliximab or detect its antibodies. Results appear on a reader while the patient waits, enabling easy optimization of treatment doses, Grifols said.

Mar 18, 2021

Roche Discovery Green HRP Kit

Roche has launched its Discovery Green HRP kit for research use only, a chromogen detection kit that can be used with other detection kits to expand the multiplexing capability of immunohistochemistry and in situ hybridization. It provides a distinct color that contrasts with other chromagens and complements other chromagens, including Discovery Yellow, Discovery Red, Discovery Purple, and Discovery Teal, to multiplex up to seven biomarkers simultaneously. 

The chromagens have translucent properties so researchers can analyze the co-localization of multiple biomarkers through the spatial overlapping of two signals in the context of tissue, Roche said. The kit can be fully automated on the Discovery Ultra system. 

Mar 17, 2021

Quest Diagnostics: At-Home FIT

Quest Diagnostics this week launched its at-home collection fecal immunochemical test, which is used to screen for colorectal cancer in stool samples. If blood is found in the sample, further screening and evaluation, such as a colonoscopy, will be recommended. Patients using the test, offered through the QuestDirect business, will be sent a collection kit via FedEx along with a prepaid FedEx shipping label and envelope by which the sample can be sent to Quest for testing.

Mar 17, 2021

Randox Laboratories: Acusera Control

Randox Laboratories has launched its new range of Acusera Control for D-dimer testing, used to test whether a patient has a blood clotting disorder. The control, for use on a variety of different diagnostic systems, comes in a liquid frozen format and is stable for 28 days when stored between 2 degrees Celsius to 8 degrees Celsius, the Crumlin, Northern Ireland-based firm said.

Mar 09, 2021

Meridian Bioscience Air-Dryable Direct DNA qPCR Blood Mix

Meridian Bioscience has launched its new Air-Dryable Direct DNA qPCR Blood Mix designed for the manufacturing of room temperature-stable molecular diagnostic tests direct from whole blood, plasma, or serum. The mix uses a specialized polymerase and advanced buffer formulation designed specifically for blood samples without the need for DNA purification of the sample. PCR inhibitors in blood samples can result in false negatives or reduced sensitivity in samples where the DNA is not purified.

It is designed to tolerate a high level of inhibitors present in blood, which Meridian said allows for the development of simpler and faster tests. Meridian's mix also replaces the need for lyophilization by using an oven-drying procedure. 

Mar 05, 2021

Promega XpressAmp Direct Amplification Reagents

Promega has launched automation-friendly reagents to facilitate RNA extraction-free sample preparation, called XpressAmp Direct Amplification Reagents. The reagents allow labs to skip the RNA extraction step of a typical PCR workflow. The process consists of 10-minute lysis step with XpressAmp Lysis Buffer followed by RT-qPCR containing XpressAmp Solution. 

Mar 05, 2021

Qiagen QiaSphere for QiaStat-Dx

Qiagen has launched its QiaSphere cloud-based platform that will allow labs and users of the company's QiaStat-Dx syndromic molecular testing platform to continually monitor tests and instrument status. The platform can monitor a nearly unlimited number of instruments, providing visibility of testing routines across different hospitals or satellite labs. Customers will be able to receive instrument and test status push notifications across their personal devices, and continuous connectivity will allow Qiagen technical service to monitor instrument health in real time, the company said. Qiagen began marketing and distributing QiaSphere for the QiaCube Connect platform in early 2021.

Feb 22, 2021

Verichem Laboratories' HDL Cholesterol Verifier Kit

Verichem Laboratories launched its HDL Cholesterol Verifier Kit, which is intended for the calibration verification of high density lipoprotein and low density lipoprotein cholesterol tests. The kit contains HDL and LDL cholesterol and other liquid components from human serum without interfering substances like surfactants, glycols, and azide. It also contains a blend of "highly purified" human serum albumin, human serum globulin, and bovine gamma globulin in saline, the company said.

Using purified source components eliminates matrix variations, allowing for lot-to-lot reproducibility and consistency, the company added. The HDL and LDL cholesterol targets are determined using reference method certified calibration materials, and the material's pH, matrix composition, and protein balance are kept constant. 

The kit comes with five milliliters of material at each concentration level and have shelf-life stability of 14 months when stored between -15 and -25 degrees Celsius. It can be frozen and thawed for up to 10 cycles.

Feb 19, 2021

Guardant Health Guardant Reveal

Guardant Health has launched Guardant Reveal, a blood-based liquid biopsy test for the detection of residual and recurrent disease in cancer patients. Intended initially for the early-stage colorectal cancer space, the assay detects circulating tumor DNA in patients' blood to identify those with residual disease who may benefit most from adjuvant therapy and/or detect the first signs of a recurrence. Results are returned in as little as seven days without the need for a tissue biopsy.

Feb 16, 2021

MedTrainer LabComply

Healthcare compliance management software developer MedTrainer has launched LabComply, a learning, compliance, and credentialing software package for managing CLIA and CLIA-waived testing. Redwood, California-based MedTrainer said that the technology helps healthcare organizations manage laboratory safety, administrative, and engineering controls, training, documentation, and reporting, including verification of standard operating procedures. The firm is marketing the product to long-term care facilities and other organizations that have had to install lab equipment to handle onsite COVID-19 testing, as well as to more traditional diagnostic labs.