June 2021—PerkinElmer launched two research use only solutions, PKamp Variant­Detect SARS-CoV-2 RT-PCR Assay and the next-generation-sequencing­–based Nextflex Variant-Seq SARS-CoV-2 Kit. The PKamp VariantDetect SARS-CoV-2 RT-PCR assay can detect mutations associated with B.1.1.7, B.1.351, and P.1 variants. The Nextflex Variant-Seq SARS-CoV-2 WGS workflow can detect all SARS-CoV-2 genetic changes relative to the strain originally identified in Wuhan, China.

PerkinElmer, 203-925-4602

June 2021—AccuTec Blades launched its 2021 histology catalog under the new medical brand name, AccuThrive.

AccuThrive blades are engineered using a proprietary grinding, heat-treating, and coating formula that produces consistent, high-performing products, the company said in a press statement. Its blade enhancement process, MicroCoat Enrichment, consists of polymer coatings that “lend lubricity and resilience to the blade edge, preserving sharpness over long-term use.”

The AccuThrive portfolio also highlights many variations of gross dissection and trimming blades, coated and uncoated.

The company previously offered histology products under different brands, including Personna and GEM, but is now consolidating all medical products under AccuThrive.

AccuTec Blades, 800-336-4061

June 2021—Beckman Coulter’s Access SARS-CoV-2 IgG II antibody assay received emergency use authorization from the FDA. The semiquantitative assay measures a patient’s level of antibodies in response to a previous SARS-CoV-2 infection and provides a qualitative and numerical result of antibodies in arbitrary units. It measures IgG antibodies directed to the receptor-binding domain of the spike protein of the coronavirus.

The test has a confirmed 100 percent negative percent agreement and a 98.9 percent positive percent agreement at greater than or equal to 15 days post symptom onset. The assay can be used in random access mode and integrates into existing workflows without batch processing. Results of the test are delivered on Beckman Coulter’s immunoassay analyzers, including the DxI 800 high-throughput analyzer, which can process up to 4,800 samples per day.

The assay is available in the U.S. and countries accepting the CE mark.

Beckman Coulter, 714-993-5321

June 2021—Biocept announced it will collaborate with Protean BioDiagnostics to research the ability of Biocept’s Target Selector molecular assay to determine EGFR status in non-small cell lung cancer patients.

Protean BioDiagnostics plans to validate the analytical performance of a laboratory-developed test based on Biocept’s EGFR assay test kit in accordance with the validation process requirements of the College of American Pathologists. The research will be conducted in an independent pathology laboratory setting.

Biocept’s research use only, CE-IVD-marked assay kit enables molecular laboratories to use its Target Selector platform to analyze formalin-fixed, paraffin-embedded tissue samples and circulating tumor DNA from biological fluids. Target Selector assays with Switch-Blocker technology provide results with a DNA input of as little as 4.6 ng, which may allow laboratories to eliminate macro-dissection of tumor blocks, potentially resulting in workflow improvements and cost savings.

The quantitative assays can be used in combination with a variety of platforms including qPCR, Sanger sequencing, microarrays, and mass spectrometry, in addition to next-generation sequencing.

Biocept, 888-332-7729
Protean BioDiagnostics, 754-242-9682

June 2021—Diazyme Laboratories obtained CE-IVD marking for its SARS-CoV-2 neutralizing antibody test, a high-throughput chemiluminescent immunoassay.

The test measures the subset of neutralizing antibodies that block the interaction between the receptor binding domain of the viral spike glycoprotein and the human ACE2 cell surface receptor.

“The Diazyme neutralizing antibody test gives the scientific community and health authorities a valuable tool to evaluate the level of effective antibodies generated after infection or vaccination, and to assess adaptive immunity in studies going forward,” Chong Yuan, PhD, managing director of Diazyme, said in a press release.

The company plans to work with the FDA for emergency use authorization of the test.

Diazyme Laboratories, 888-342-9963

June 2021—Bio-Techne Corp. has reached an agreement to acquire Asuragen for initial consideration of $215 million in cash plus contingent consideration of up to $105 million upon the achievement of certain future milestones.

Asuragen’s portfolio of molecular diagnostic and research products include its FDA-cleared AmplideX Fragile X Diagnostic and Carrier Screening kit for the screening of prospective parents as potential carriers of Fragile X chromosomal abnormalities and its Quantitidex qPCR IS BCR-ABL kit to enable the monitoring of leukemia patients for minimal residual disease.

Asuragen CEO, Matt McManus, will join the Bio-Techne team to continue to lead the legacy Asuragen business as well as the integration process. Bio-Techne anticipates the acquisition to close in the fourth quarter of its fiscal 2021.

Bio-Techne, 612-379-2956
Asuragen, 512-681-5200

June 2021—Thermo Fisher Scientific announced the FDA has expanded emergency use authorization for the Applied Biosystems TaqPath COVID-19 Combo Kit to include the high-throughput Thermo Fisher Scientific Amplitude solution.

The Amplitude solution is a molecular diagnostic testing system that aims to help clinical labs expand their testing capacity by combining the company’s extraction and real-time PCR instruments with liquid-handling products from the Tecan Group. The modular system uses a high-throughput version of Thermo Fisher’s Applied Biosystems TaqPath COVID-19 Combo Kit, which received emergency use authorization in March 2020, to process samples in four steps. The platform can process up to 8,000 samples per day.

Testing with the Amplitude solution and the TaqPath COVID-19 combo kit is limited to CLIA-certified laboratories to perform high-complexity tests, or by similarly qualified non-U.S. laboratories.

Thermo Fisher Scientific, 781-622-1000

June 2021—Roche launched its Discovery Green horseradish peroxidase (HRP) kit, to identify and profile biomarkers and cell populations in tissue-based research.

The kit can be used in combination with other detection kits, expanding the multiplexing capability of immunohistochemistry and in situ hybridization by providing a distinct color that contrasts with other chromogens. Discovery Green HRP complements chromogens including the company’s Discovery yellow, purple, red, and teal for multiplexing up to seven biomarkers simultaneously.

The research use only kit is supplied in ready-to-use dispensers and provides a stable staining signal during alcohol dehydration. It can be fully automated on the Discovery Ultra system.

Roche, 317-521-2000

June 2021—DiaSorin received emergency use authorization from the FDA for its Liaison SARS-CoV-2 Ag.

The test uses chemiluminescence immunoassay technology to determine the presence of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal dry swabs and nasopharyngeal swabs, eluted in universal transport medium, and is used to assist in the diagnosis of acute COVID-19 infection through qualitative detection of the virus.

In clinical studies the test showed a 97 percent sensitivity within 10 days after the onset of symptoms and a 100 percent specificity on anterior nasal swabs. Nasopharyngeal swabs showed a 96.1 percent sensitivity and a 99.3 percent specificity.

DiaSorin received funding from the Biomedical Advanced Research and Development Authority for the development, validation, FDA emergency use authorization, and submission of 510(k) clearance of the test.

The Liaison SARS-CoV-2 Ag runs on the company’s Liaison XL platform.

DiaSorin, 562-240-6500

June 2021—Qiagen received emergency use authorization for its QIAreach Anti-SARS-CoV-2 Total Test, a digital assay to detect total SARS-CoV-2 antibodies (IgA, IgG, IgM).

The serological test has been shown to have a sensitivity of 93.85 percent (confidence interval [CI], 84.99–98.30 percent) and a specificity of 97.83 percent (CI, 95.00–99.29 percent). The test was developed in partnership with Ellume and uses the digital eHub and eStick system. One QIAreach eHub can handle up to eight samples on eight eSticks simultaneously, with each eStick test running independently. Up to 32 samples can be processed in one hour, and results are available in about 10 minutes.

Qiagen, 800-426-8157