January 31, 2018 | January featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including PerkinElmer, Roche, Charles River, and more.
PerkinElmer announced the launch of its NeoBase 2 non-derivatized MSMS Kit, which obtained CE mark approval allowing distribution in Europe. This new in-vitro diagnostic (IVD) kit is intended for the semi-quantitative measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside, and lysophospholipid concentrations. The kit analyzes newborn heel prick blood samples dried on filter paper and is used with a tandem mass spectrometer. The NeoBase2 MSMS kit can test for up to 57 analytes, including markers for screening of X-linked adrenoleukodystrophy (X-ALD), the most common peroxisomal disorder. It can also screen for adenosine deaminase severe combined immunodeficiency (ADA-SCID), which is caused by a deficiency of the enzyme ADA and is the second most common SCID. The NeoBase2 MSMS kit enables labs to use a simple three-step assay workflow to screen for more disorders in less time from a single dried blood spot punch. PerkinElmer’s optional MSMS Workstation software, which includes database functionality, helps labs effectively store, manage, review and report results. Press Release
Roche announced the launch of the CE-marked VENTANA MMR IHC Panel, which provides clinicians with a comprehensive group of immunohistochemistry (IHC) tests for patients diagnosed with colorectal cancer. The tests detect certain proteins associated with a DNA repair mechanism called mismatch repair (MMR), and aid in differentiating between sporadic colorectal cancer and probable Lynch syndrome, a hereditary form of colorectal cancer. About 3 percent of colorectal cancers are associated with Lynch syndrome. The VENTANA MMR IHC Panel includes four assays that target MMR proteins MLH1, PMS2, MSH2 and MSH6, as well as the VENTANA BRAF V600E (VE1) assay. It is available for use on the BenchMark GX, XT and ULTRA instruments. Press Release
Fluxion Biosciences announced that its ERASE-Seq bioinformatics solution can now be utilized for variant calling from a wide range of targeted cancer panels. Until now, ERASE-Seq was limited to use on Fluxion's 59-gene Spotlight 59 Cancer Panel. ERASE-Seq is now available for use with Swift Biosciences' Accel Amplicon 56G panel and Illumina's TruSight Tumor 15 panel. Other custom and commercial panels are also compatible with ERASE-Seq, and can be added following validation testing by Fluxion. Liquid biopsies offer the potential to improve treatment of cancer by providing affordable, non-invasive detection of actionable cancer mutations from a blood sample. However, the relative abundance of cancer DNA in blood is extremely low, below the sensitivity threshold of standard sequencers. Approaches such as molecular barcodes have resulted in improved performance; however, high sensitivity and, importantly, high specificity have been difficult to achieve at allele frequencies between 0.1-0.5%. This is a critical region for somatic cancer variant detection in liquid biopsies, and ERASE-Seq provides far superior accuracy here compared to competitive approaches. "Fluxion's ERASE-Seq bioinformatics solution utilizes statistical processing and background modeling to reduce both systematic (repeated) errors as well as random errors (noise), without the need for molecular barcodes (unique molecular IDs, or UMIs)," states Cristian Ionescu-Zanetti, CTO, in a press release. "ERASE-Seq provides levels of performance unachievable with any other method- maintaining exceptional sensitivity and specificity to below 0.1% allele frequency. Our customers are very excited that they can now apply ERASE-Seq to existing panels that their lab has already adopted." Press Release
Charles River Laboratories announced that it has acquired KWS BioTest. The addition of KWS enhances Charles River’s discovery expertise, with complementary offerings that provide our clients with additional tools in the active therapeutic research areas of oncology and immunology. James C. Foster, Chairman, President and Chief Executive Officer of Charles River, said in a written statement, “The addition of KWS strategically expands Charles River’s existing discovery capabilities in the field of immunology, which is critical given the importance of new therapies which harness the human immune system. In addition to enhancing our position as the premier single-source provider for a broad portfolio of discovery services, KWS increases our ability to support clients’ early-stage drug research in critical therapeutic areas, and expands our geographic footprint in the United Kingdom.” The purchase price was approximately £15 million in cash (approximately $20 million based on current exchange rates), subject to certain post-closing adjustments. In addition to the initial purchase price, the transaction includes a potential additional payment of up to £3 million based on future performance (approximately $4 million based on current exchange rates). The transaction is not expected to be material to 2018 GAAP or non-GAAP results from operations. Press Release
CellMax Life announced results from a new study showing that its circulating tumor cell (CTC) blood test, based on its proprietary CMx platform, can detect colorectal cancer at an early stage – and in many cases, pre-cancerous lesions – with accuracy ranging from 84 to 88%. Colorectal cancer is among the most preventable cancers when detected early. Yet, it is the second leading cancer killer in the United States. Traditional methods like colonoscopies and stool-based tests are invasive or inconvenient. For these reasons, compliance with colorectal cancer screening remains low, leading to most colorectal cancers being detected in late stages, when survival rates are poor. "The positive results of this study prove that the CellMax CTC blood test can address the unmet need for a convenient and accurate test for early colorectal cancer detection; since the test only requires a routine blood draw, it can be easily integrated into a patient's regular physical exam, increasing compliance," said study co-author Ashish Nimgaonkar, a gastroenterologist and medical director at the Center for Bioengineering Innovation & Design at Johns Hopkins University, said in a press release. "Additionally, research conducted by the American Cancer Society and Centers for Disease Control and Prevention states that test affordability is the number one reason patients cite for not undergoing regular screening for colorectal cancer. This blood test could potentially be offered between $100 and $150." Press Release
Amoy Diagnostics announced that China Food and Drug Administration (CFDA) approved its Super-ARMS EGFR Mutation Test for use with plasma samples, as a companion diagnostic for non-small cell lung cancer (NSCLC) therapy with EGFR-TKIs on January 19. It is the first companion diagnostic kit approved by CFDA for the detection of the epidermal growth factor receptor (EGFR) gene mutations in circulating tumor DNA (ctDNA) derived from plasma. Patients with NSCLC carrying EGFR activating mutations, such as exon 19 deletions, L858R mutation, or T790M mutation, are candidates for the EGFR-targeted therapy with EGFR-TKIs. Many patients do not have the opportunity to be selected for targeted therapies due to variable difficulties in obtaining sufficient tumor tissue for the test. The CFDA approval of the Super-ARMS EGFR Mutation Test for use with plasma will help alleviate those barriers to molecular testing by giving clinicians more options for their patients. This unique test kit has been CE-IVD approved since April 2017. “The development of liquid biopsy-based diagnostics in non-small cell lung cancer will transform the diagnostic workup of advanced stage patients. The ability to both isolate and genetically interrogate tumor DNA from a simple, minimally invasive test that can subsequently inform treatment decisions will benefit a lot to physician and patient,” said Yi-long Wu of Guangdong General Hospital, former President of Chinese Society of Clinical Oncology (CSCO), in a press release. “The CFDA approval of our Super-ARMS EGFR Mutation Test for liquid biopsy for companion diagnostics sets a new standard in treating patients with NSCLC,” Li-mou Zheng, founder and CEO of AmoyDx, said in a written statement. “We are glad to see that the patients in China who are unable to provide tissue samples will have an opportunity to receive precision treatment. In the future we will adhere to our mission of providing customers with superior and innovative products and services to improve healthcare and patients’ lives.” Press Release
Cancer Genetics announced the expansion of its immuno-oncology (IO) panel, Complete::IO, to include five new IO markers. This brings the total number of markers it simultaneously detects to 27, making Complete::IO the most comprehensive flow-cytometry-based biomarker panel in the industry, with a 24-hour turn around time. Since its launch in April 2017, Complete::IO has quickly gained commercial traction and has already been included in notable immunotherapy trials including studies of CAR-T therapies and checkpoint inhibitors. Complete::IO is a multi-marker panel enabling comprehensive characterization of the immune repertoire of cancer patients, including circulating immune cell populations and the tumor microenvironment. It plays a unique role in identifying ideal patient populations for specific IO therapies and addresses the unmet need to monitor and stratify patient populations during clinical trials. The panel also assures that patients are monitored for safety and toxicity throughout the trial. The increased number of markers allows for the identification of rare and challenging subsets of immune cells. Besides the commonly studied subsets, central memory, effector, effector memory cells, naïve CD4+ and CD8+ T cells, T-regs, B-regs, NK, and plasmacytoid dendritic cells, Complete::IO is now able to power highly accurate immunophenotyping and the measurement of the frequency of myeloid-derived suppressor cells (MDSCs), as well as those that express PD-1, PD-L1, or PD-L2. The presence and frequency of MDSCs, which inhibit anti-tumor immune response, in the blood of cancer patients, might represent a novel and accessible biomarker to monitor clinical outcome and response to therapy. In addition, targeting MDSCs to increase the efficacy of immunotherapeutics appears to be a clinically promising strategy, and is being actively evaluated in clinical trials. According to industry reports, there are over 2,500 active clinical trials globally related to IO therapies. Press Release