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FDA Approves First NGS-Based CDx for Lung Cancer, Rady Children’s New Screening Initiative, More

August 31, 2022 | An ultramodern laboratory for prostate cancer diagnoses opens in Sweden; a flow cytometry-based companion diagnostics platform matches patients with life-changing treatments for cancer and other diseases; a new RNA-targeted oncology pipeline boasts therapeutic and diagnostic capabilities; and more. 

Cue Health announced the nationwide launch of Cue Care, a same-day, at-home, test-to-treatment solution. The Cue Care antiviral delivery service includes a televisit with a healthcare professional and same-day medication delivery from the Cue Health App, the cost of which is currently covered by the U.S. Department of Health and Human Services. Cue Care is expected to handle other respiratory infections, such as strep throat and respiratory syncytial virus, as well as sexually transmitted infections, such as chlamydia and gonorrhea. Cue has the most accurate at-home COVID-19 test, delivering results in 20 minutes to connected mobile devices. It detects all known COVID-19 variants of concern in people with or without symptoms. Press release

Rady Children’s Institute for Genomic Medicine (RCIGM) has published an article in the American Journal of Human Genetics (DOI: 10.1016/j.ajhg.2022.08.003) describing a scalable prototype for newborn screening (NBS) that includes the diagnosis of genetic diseases by rapid Whole Genome Sequencing (rWGS) and virtual acute management guidance. RCIGM developed the NBS-rWGS system with a self-learning capacity to refine and increase the results with time. In June, RCIGM formally launched NBS-rWGS under its new name, BeginNGS. The goal is for BeginNGS to become the genetic disease screening standard, testing for ~1,000 disorders and sequencing 3.7 million newborns in the United States annually. Press release

PathAI announced a multi-year expanded collaboration agreement with Bristol Myers Squibb. The initial work will focus on key translational research in oncology, fibrosis, and immunology, with an overall goal of transitioning into clinical trials. Bristol Myers Squibb and PathAI will use AI pathology models with the potential to de-risk therapeutic development across Bristol Myers Squibb’s pipeline. In addition, the companies plan to leverage these models to help enhance patient segmentation in clinical trials across multiple disease indications and develop AI-powered diagnostics, including measuring CD8 T-cell infiltration across oncology areas. Press release

Inify Laboratories is on track to build its first ultramodern laboratory at Campus Solna, Sweden. The company expects to move into the new facility during the fourth quarter of 2022 and immediately commence installing systems and equipment, followed by accreditation. The laboratory will begin production of prostate cancer diagnoses sometime during the first half of 2023. Inify continues to develop and integrate a specially designed IT system and process built to support a fully digital, standardized workflow and reporting system. Press release

The U.S. Food and Drug Administration (FDA) granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) that identifies non-small cell lung cancer (NSCLC) patients whose tumors have HER2 activating mutations and who may be candidates for ENHERTU (fam-trastuzumab deruxtecan-nxki), an engineered HER2-directed antibody-drug conjugate. The FDA approved ENHERTU following a Priority Review granted by the U.S. FDA in April 2022. The Oncomine Dx Target Test is the only distributed NGS CDx that has received regulatory approval and simultaneously evaluates 23 genes associated with NSCLC. The test received its first approval by the FDA as a CDx in 2017. In the US alone, it is approved for seven targeted therapies for NSCLC and one for cholangiocarcinoma. Press release

Becton, Dickinson, and Company, widely known as BD, announced a collaboration with Labcorp to develop, manufacture, market, and commercialize flow cytometry-based companion diagnostics (CDx), intended to match patients with life-changing treatments for cancer and other diseases. The two companies bring together capabilities that comprise an end-to-end solution for CDx development for the pharmaceutical industry. Their joint offering ranges from exploratory panel development to U.S. Food and Drug Administration approval of diagnostic and IVD kit manufacturing and distribution. Press release

Arabian International Healthcare Holding Company (“Tibbiyah”), an integrated healthcare solutions provider in Saudi Arabia, announced a definitive Joint Venture Agreement with BGI Almanahil Health for Medical Services, a subsidiary company of BGI Health, in the formation and operation of a limited liability company to be called Saudi Advanced Medical Lab LIMITED in Saudi Arabia. The new company, owned 50% by BGI Almanahil and 50% by Tibbiyah, will provide clinical laboratory testing and bio-information services to hospitals, research institutes, and medical centers and clinics for the public and private sectors. Press release

The University of Texas MD Anderson Cancer Center and TransCode Therapeutics announced a strategic alliance to advance TransCode’s RNA-targeted oncology therapeutic and diagnostic candidates pipeline. TransCode and MD Anderson scientists will collaborate on preclinical studies to further validate TransCode’s therapeutic and diagnostic candidates and expand the reach of TransCode’s discovery engine. The collaboration has the potential to inform multiple clinical programs in TransCode’s pipeline, starting with its lead therapeutic candidate designed to treat numerous metastatic cancers. Press release

The Alliance for Clinical Trials in Oncology, in partnership with the National Cancer Institute, part of the National Institutes of Health, announced the opening of a new study that aims to assess the utility of early cancer detection blood tests. The Alliance Multicancer Early Detection (MCED) Biobank Study will enroll approximately 2,000 men and women aged 40 to 75 who are either healthy individuals without cancer, individuals with untreated cancer, or individuals who may have cancer. These blood tests identify the presence of multiple cancers before symptoms occur. The Alliance MCED Biobank Study will also incorporate a new web-based tool called the Alliance Participant Engagement Portal. This optional resource will allow participants to receive direct updates about the study's progress via text or e-mail. Press release.

KSL Beutner Laboratories launched a first-to-market indirect immunofluorescence serum blood test in the U.S. that positively identifies laminin 332, an antigen associated with the chronic autoimmune disease mucous membrane pemphigoid (MMP). Beutner’s laminin 332-specific serological assay reduces diagnosis times from as much as two years to 72 hours or less. Confirming laminin 332 MMP relies on several laboratory tests offered by Beutner: first, a direct immunofluorescence microscopy of a skin biopsy to detect tissue-bound immunoreactants. Next, indirect immunofluorescence identifies circulating antibodies targeting autoantigens in the skin's basement membrane zone. Press release

The National Institutes of Health announced the winners of its NIH Technology Accelerator Challenge (NTAC) for Maternal Health, a prize competition for developers of diagnostic technologies to help improve maternal health worldwide. The winning technologies share $1 million in prizes for successfully developing diagnostic tests and platform technologies to reduce maternal morbidity and mortality. Dr. Bethany Hedt-Gauthier, Harvard University, Boston, received first place and a $500,000 prize for mHealth tools for community health worker-led home-based diagnosis of surgical site infections and anemia post-cesarian delivery. Details concerning the other cash prize winners and honorable mention awards can be found on the NTAC for Maternal Health program website. Press release.

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