#InVitroInsider?(September)

Welcome to the September edition of In Vitro Insights, your go-to source for staying well-informed about the latest breakthroughs, perspectives, and advancements in the dynamic field of in-vitro diagnostics (IVD).

In this month's issue, we are thrilled to share some exciting news from the financial arena. The funding landscape is showing promising signs, as an impressive $202 million has been injected into start-ups within the IVD sector. This influx of capital signifies a growing recognition of the immense potential and significance of innovations in the field of in-vitro diagnostics.

Company Spotlight: Evvy Closes $14m Series A for Vaginal Microbiome Testin

Evvy is dedicated to addressing the gender health gap by uncovering and harnessing often-overlooked female biomarkers, beginning with the study of the vaginal microbiome. In 2021, Evvy introduced the world's first and sole at-home vaginal microbiome test, utilizing metagenomic sequencing to provide insights into the vaginal microbiota, its significance, and actionable steps. These insights have paved the way for the growth of Evvy's pioneering vaginal health platform, which now integrates cutting-edge testing, precise care, and proactive monitoring to offer comprehensive healthcare for women and individuals with vaginas. Through this platform, Evvy is amassing real-world data sets crucial for revolutionizing our comprehension of intricate health conditions within the female body.

Since its July 2021 launch, Evvy has achieved numerous milestones in women's health:

• Introduced the world's first and only CLIA/CAP certified at-home vaginal microbiome test, utilizing metagenomic sequencing for comprehensive screening of vaginal and urinary tract microbes with exceptional sensitivity and specificity.
• Generated the largest and most extensive dataset on the vaginal microbiome, including longitudinal molecular and phenotypic information.
• Launched an AI-powered, personalized vaginal healthcare platform, supported by an IRB-approved study demonstrating its positive impact on the vaginal microbiome.
• Established Equal Research Day, a gender health awareness initiative akin to Equal Pay Day, involving doctors, celebrities, patients, and investors. Additionally, assembled a leading advisory board of OB/GYNs and women's health researchers.
• Cultivated a community of over 200k+ followers across various platforms, promoting scientifically grounded and destigmatized vaginal health education and peer support, thereby revolutionizing discussions about vaginal health.

We spoke with Pita Navarro Co-Founder & Chief Science Officer, she was enthusiastic about the future. Pita

"Evvy's technology is not just about innovation; it's about transformation. Our AI-powered platform and comprehensive datasets on the vaginal microbiome aim to reshape the way society understands and caters to women's health, ensuring that every woman gets the precision care she deserves. We believe our research-centric approach is a stepping stone towards a more inclusive and data-driven healthcare system.

"This funding is a testament to the trust and belief our investors have in Evvy's mission. It provides us with the fuel to scale our platform, dive deeper into research, and work diligently to redefine standards in women's healthcare."

Website: https://www.evvy.com/about

Founders: Pita Navarro, Priyanka Jain , Laine Bruzek

Congratulations!

Collaboration of the month: Biological Dynamics partners with Pancreatic Cancer Consortium on early detection study

Biological Dynamics is a leading company specializing in exosome-isolation technology for the early detection of diseases, has entered into a multi-year partnership agreement with the Pancreatic Cancer Early Detection (PRECEDE) Consortium. This collaboration aims to advance patient surveillance techniques for the early stages of pancreatic cancer by leveraging Biological Dynamics' ExoVita Pancreas Assay, which is powered by the Verita platform.

Biological Dynamics becomes PRECEDE's liquid biopsy partner, aligning with their objective of detecting cancer at an earlier stage to improve patient survival rates. This partnership expedites the enrollment of a minimum of 5,000 patients into Biological Dynamics' ExoLuminate Study (NCT05625529). This multi-site clinical study is specifically designed for individuals with an elevated risk of pancreatic cancer and focuses on early detection of pancreatic ductal adenocarcinoma (PDAC).

"We’re thrilled to work with PRECEDE to advance our shared goal of increasing pancreatic cancer survival rates and to further clinically validate the Verita platform and ExoVita assay for detecting cancer earlier using a new generation of exosome-based biomarkers and technology,” said Paul Billings MD PhD,

More Funding!

Adela, Inc. Closes $48M Financing

Adela, Inc. Announces $48 Million in Financing and Leadership Addition to Advance Tissue-Agnostic Minimal Residual Disease (MRD) Monitoring Product Portfolio Based on Genome-Wide Methylome Approach. This recent funding brings its total raise to $108 million, impressive!

Website: https://www.adelabio.com/

Founders: Scott Bratman , Maneesh Jain & David Scheer

Harbinger Health Raises $140 Million in Series B Financing

Harbinger Health Raises $140 Million in Series B Funding to Accelerate Advancement of its Screening Platform for Early-Stage Cancers. The funding will facilitate the achievement of clinical validation for Harbinger's blood-based cancer screening product, support additional efforts in generating evidence, and allow for the continued expansion of the organization in preparation for the expected product launch in 2025.

Website: https://www.harbinger-health.com/

Founders: Alexander Meissner & Franziska Michor

The Latest in IVD:

?? Genetic Signatures Files 510(k) Application for GI Parasite Detection Kit

?? Lab Genomics Acquires QDx Pathology

?? Circular Genomics , Washington University Researcher to Explore circRNA as Alzheimer's Biomarker

?? Natera Launches $250M Follow-On Stock Offering at $55 Per Share

?? PacBio Partners With Lab Automation Firms on Sample Prep

?? Lucence Presses Forward With Favorable Results From Liquid Biopsy Lung Cancer Studies

?? Biocept, Inc. Licenses CNSide Liquid Biopsy Assay to Plus Therapeutics

?? Delve Bio Seeks to Commercialize UCSF Metagenomic Pathogen Test

?? T2 Biosystems Gets FDA 510(k) Clearance for Biothreat Panel

?? Invitae Publishes First Validation Data on MRD Assays, Laying Path to Future Clinical Expansion

?? Cue Health to Implement Shareholder Rights Plan

?? FDA Releases Proposed Rule for Oversight of Laboratory-Developed Tests

?? Renovo Bioscience to Acquire Multiomic, Multimodal AI Bioinformatics Startup GEDiCube

Do you have any thoughts, or news to share? Join the conversation on LinkedIn by following the hashtag?#InVitroInsider, and follow my page to participate in monthly polls to share your insight!

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