In-Vitro Insider (August)

#InVitroInsider?(Vol 5)

Welcome to the August edition of In Vitro Insider, your trusted resource for the latest advancements, insights, and trends in the in-vitro diagnostics (IVD) market. As the IVD industry continues to grow and transform, it's vital to stay well-informed about the most recent technologies, regulations, and market dynamics.

Whether you're an IVD pro, a curious researcher, or simply someone enthusiastic about biotech, In-Vitro Insider is here to help you stay ahead. In each monthly edition, we'll bring you the latest news from the IVD world, exploring the newest diagnostic technologies and highlighting recent breakthroughs in the field.

If you're keen on being part of an upcoming edition or want to collaborate, feel free to get in touch with us. We're excited to hear from you!

Company Spotlight: Sensible Diagnostics announces NIH RADx award of ~$1 million

Curative spin-out Sensible Diagnostics, Inc. whose aim is to commercialize their ground-breaking point-of-care PCR testing platform has been awarded up to $1 million in funding from the National Institutes of Health for the development for their multiplex test for COVID-19 and influenza A/B.

The sensible team are in the process of creating a test that can be executed within a span of 10 to 15 minutes. The company has stated that this test will be priced equivalently or even more affordably compared to existing molecular tests and CLIA-waived antigen tests.

Sensible has also disclosed its ongoing work on a distinct test targeting group A Streptococcus. Furthermore, the company has outlined its intentions to design extra tests intended for sexually transmitted infections, encompassing hepatitis C and HIV infections. Additionally, they are planning to formulate a panel for screening new-borns for various infectious diseases.

We spoke to Ernest Templin , CEO & Co-Founder "I'm so proud of our small team and our vendors, and of how much we've been able to accomplish in the past 7 months since spinning out. With the FDA's green light on our Group A Strep trials, and with our involvement in the RADx Tech initiative, we should be able to offer a full suite of 10-minute PCR respiratory tests on the Sensible point-of-care platform by next respiratory?season"

Collaboration of the month: ChromaCode & Protean BioDiagnostics Partner to Launch Lung Cancer Test

ChromaCode, Inc. and Protean BioDiagnostics have formed a strategic alliance to introduce a non-small cell lung cancer test in the United States. This test will be accessible through an early access program and utilizes ChromaCode's advanced high-definition PCR multiplexing technology. With a turnaround time of less than 24 hours, the HDPCR NSCLC assay can efficiently detect all genetic variations suggested by the National Comprehensive Cancer Network (NCCN) in a single multiplexed analysis.

Designed to function even with minimal sample quantities, only 15 nanograms (ng) of input DNA and 5ng of RNA are required for the assay. The evaluation exhibited extensive coverage of target genes, exceeding 99%, and demonstrated a concordance of 99% with next-generation sequencing. These results establish the superiority of the HDPCR NSCLC assay over traditional biomarker testing, a fact highlighted by ChromaCode.

Protean president and CEO Anthony Magliocco MD said: “We value the rapid turnaround and clinically relevant markers of the HDPCR NSCLC assay. We see a real opportunity to collaborate with commercial payors, US Department of Veterans Affairs, and other government agencies, to establish coverage and reimbursement for this revolutionary technology.”

The Latest in IVD:

?? Myriad Genetics & Onsite Women's Health Partner to ID Women With High Breast Cancer Risk

?? DELFI Diagnostics Boosts Lung Cancer Detection Power With Addition of Mutational Profiles

?? GRAIL Nonprofits to Explore Multi-Cancer Early Detection Testing in Underserved Populations

?? FDA approves Foundation Medicine CDx for Use With Janssen Drug in Prostate Cancer Patients

?? Helix & Nebraska Medicine Partner to Launch Genomic Health-Risk Screening Program

?? GENinCode Predictive Genetics Files FDA 510(k) Submission For Polygenic Cardiovascular Disease Risk Test

??Lung Cancer Data Heralds Shift for Hummingbird Diagnostics GmbH s to Focus on Early Detection

?? 美国BD公司 Gains FDA Clearance for Combination COVID-19, Flu, RSV Molecular Test

?? Exact Sciences Details Late-Year MRD Testing Plans, Highlights Cologuard Growth

?? CareDx, Inc. Receives Medicare Coverage for HeartCare Multimodal Heart Transplant Surveillance

?? Guardant Health & Illumina Settle Patent Suit, Renew Long-Term Commercial Partnership

?? Adaptive Biotechnologies Corp. Sees ClonoSeq Test Volume Grow, Reports 12 Percent Revenue Growth for Q2

?? Amber Bio Raises $26M in Seed Funding

?? Fulgent Genetics Core Revenues Jump 48%

?? Cue Health Awarded $28M BARDA Contract to Develop Multiplex Respiratory Test

?? Phase Genomics gets $2.5M in Grants to Develop Diagnostic Score For Genomic Aberrations in Cancer

?? NGeneBio Co., Ltd. partners with MGI on Precision Cancer Diagnostics

?? CrisprBits Private Limited forms strategic partnership with Molbio Diagnostics

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