#InVitroInsider (October)

Welcome to the October edition of In Vitro Insider, a 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 $116 million has been pumped 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: AOA Dx Secures $17M to Advance Its Ovarian Cancer Diagnostic Test

AOA Dx is at the forefront of advancing early-stage cancer detection through its groundbreaking research in glycolipids and exclusive biomarker technology. Thier innovative platform, GlycoLocate?, centered around tumor marker gangliosides, is leading the way in life-saving early cancer identification.

In a pioneering move, AOA Dx has introduced AKRIVIS GD?, an early-stage liquid biopsy test designed for ovarian cancer, which has exhibited exceptional sensitivity and specificity in a recent research study.

AOA Dx was established by Anna Milik Jeter , Oriana Papin-Zoghbi and Alexander Fisher who are enthusiastic advocates for women's health.

On October 11, 2023, AOA Dx achieved a successful funding round closure, securing $17 million to expedite the advancement of its liquid biopsy test for ovarian cancer. Leading this round was Good Growth Capital , and it saw the active involvement of prominent industry investors.

The recent infusion of capital will be allocated to support this critical trial, facilitate the expansion of laboratory facilities in Denver, Colorado, and further enhance the tumour marker ganglioside platform.

We spoke with Oriana Papin-Zoghbi who said "At AOA Dx we're on a mission to revolutionize the diagnosis of ovarian cancer and beyond. ?We're pioneering ground-breaking work with novel biomarkers known as tumour marker gangliosides. These biomarkers hold the potential to transform early detection and give cancer patients the tools they need to get time-critical treatments.? As we continue to expand our team, we are looking for individuals who share our passion to make early detection a new reality and are ready to work in a fast-paced start-up where no two days are alike. We're an agile team, embracing a growth mindset that focuses on results, and take pride in understanding and utilizing our individual strengths to expedite bringing diagnostic tools to market that are set to transform early detection."

Congratulations to the AOA Dx and good luck for the next milestone!

Collaboration of the month: 凯杰 & Myriad Genetics Partner to Develop Cancer Companion Diagnostic

On Thursday 26th October, 凯杰 and Myriad Genetics unveiled a collaboration agreement with the aim of developing companion diagnostic tests for cancer.

Their objective is twofold: to create laboratory-developed cancer tests for the United States clinical market and to produce readily distributable companion diagnostic test kits for the worldwide market.

Initially, the focus of their collaboration will be to work closely with pharmaceutical partners to develop assays, making use of advanced techniques such as next-generation sequencing workflows or Qiagen's Qiacuity digital PCR platform.

Myriad Genetics will make use of its CLIA-certified and CAP-accredited laboratory platform, its expertise in assay development, and its commercial infrastructure for conducting clinical sample tests. In contrast, Qiagen will lend its expertise in sample preparation, PCR (polymerase chain reaction), digital PCR, next-generation sequencing, and its Digital Insights bioinformatics portfolio. Qiagen will also bring to the table its good manufacturing practices (GMP)-certified product manufacturing capabilities and global commercial distribution channels.

In addition to their current collaboration, Qiagen and Myriad are contemplating potential joint initiatives concerning the detection of minimal residual disease (MRD) and homologous recombination deficiency (HRD).

"We are pleased to collaborate with Myriad, combining their expertise in complex and proprietary lab-developed tests with our proficiency in distributable kit-based solutions, to offer a comprehensive global companion diagnostic approach," Jonathan Arnold , Qiagen's VP and head of translational science and precision diagnostics, said in a statement.

"Our partnership with Qiagen creates a comprehensive companion diagnostic development and commercialization solution for our pharma partners that will support the advancement of cancer care and personalized treatment decisions for patients worldwide," said Paul Bartel SVP?of companion diagnostics at Myriad Genetics

More Funding!

Precede Biosciences Enters the market with $57M in funding

Emerging from stealth with a bang! Precede Biosciences is now presenting its initial clinical data for its liquid biopsy platform, which is primarily focused on cancer.

The company's ultimate goal is to facilitate clinical diagnoses, enhance therapy management, and support drug development efforts.

Precede Biosciences made its public debut in early October, coinciding with the announcement of a successful $57 million seed funding round. This round of funding was supported by investors including Dana-Farber’s Binney Street Capital and 5AM Ventures’ 4:59 Initiative, among others.

Website: https://www.precede.bio/

Founder: Rehan Verjee

Molecular Detection Startup VedaBio Secures $40M in Series A Financing

VedaBio , a biotechnology company based in San Diego, California, has successfully secured over $40 million in initial funding for its operations. This funding round was led by OMX Ventures and included participation from a group of family offices, such as Kleinmuntz Associates.

The primary purpose of this funding is to support VedaBio's expansion of operations, enhance its research and development activities, and extend its business reach.

VedaBio is led by a team that includes CEO Anurup Ganguli, Chief Medical and Scientific Officer and President Christine Ginocchio, PhD, MT (ASCP), as well as Chief Operating Officer Fred Sweeney, PhD. The company specializes in providing a platform for rapid molecular detection of multiple analytes, achieving high accuracy without the need for target amplification. Their CRISPR Cascade? technology combines speed and precision without the requirement for target amplification, all while maintaining accuracy levels comparable to PCR.

In addition to this funding announcement, VedaBio has also introduced key leaders to their team, including

Will Harris as VP of Strategic Marketing,

Ravi Vijayendran as SVP of Technical Operations and Quality,

Don Masquelier as VP of Engineering,

Phil Belgrader as VP of Systems Integration,

Sally Brashears as VP of Intellectual Propert

Website: https://vedabio.com/

Founder: Anurup Ganguli, PhD

Previse Wins $1.8M NIH Grant to Help Advance Esophageal Cancer Risk PCR Test

Founded in 2018, Previse is an innovative molecular diagnostics company that is dedicated to the prevention and detection of esophageal cancer. Esophageal cancer ranks as one of the most lethal cancers globally and, in 2023, stands as the second deadliest cancer in the United States, trailing closely behind pancreatic cancer. Previse's overarching mission is to save lives by focusing on the prevention and early detection of cancer, with a specific emphasis on esophageal cancer.

Previse achieves its objectives by harnessing cutting-edge biomarker technology developed by Dr. Stephen Meltzer and his GI Early Detection Biomarker Lab at the Johns Hopkins University School of Medicine. This technology, supported by funding from the National Institutes of Health (NIH) and bolstered by decades of research, serves as the cornerstone of Previse's commitment to combat esophageal cancer.

Website: https://previsedx.com/

Founders: Stephen Meltzer & Daniel Lunz

October highlights:

?? FDA Grants Marketing Authorization for Invitae Hereditary Cancer DNA Sequencing Test

?? Natera Submits Signatera Bladder Cancer PMA Module to FDA

?? Vela Diagnostics Inks Japan Distribution Agreement for HIV-1 Drug Resistance Tests

?? Promega Corporation to Develop Microsatellite Instability Companion Diagnostic Kit With GlaxoSmithKline

?? Twist Bioscience , Bayer Ink $188M Antibody Discovery Deal

??Biocept Files for Chapter 7 Bankruptcy

?? Almac Group Plans ￡80M Expansion, Including ￡15M for Diagnostics Facility

?? Caris Life Sciences Partners with Moderna to Help Develop mRNA-Based Cancer Therapeutics

?? 雅培 PCR Test Gets FDA Approval as CDx for Servier's Tibsovo for Rare Blood Cancer

??23andMe GSK Ink $20M Expanded Collaboration to Broaden Access to Genetic Database

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