On March 3, 2022 CancerIQ, the platform powering early cancer detection and prevention across broad patient populations, reported it closed a $14 million Series B financing round co-led by Merck Global Health Innovation Fund (Merck GHI) and Amgen Ventures (Press release, CancerIQ, MAR 3, 2022, View Source [SID1234609493]). McKesson Ventures, OSF Ventures (the investment arm of OSF HealthCare, a current CancerIQ customer), as well as CancerIQ’s Series A lead investor, HealthX Ventures, also participated in the Series B round.

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The new funding comes one month after a report from the President’s Cancer Panel calling for "urgent and immediate action" to close gaps in cancer screening, risk assessment, and timely follow-up care — particularly among diverse, uninsured or underinsured, and rural populations.

Systemic access barriers have created stark inequality when it comes to preventive cancer care in the United States. For example, Black women are more likely to be diagnosed with advanced stages of breast cancer and 41% more likely to die of the disease than white women. These issues are compounded by the 9.5 million screenings missed during the COVID-19 pandemic, which has led to an increase in late-stage cancer diagnoses that are more costly and have a greater impact on quality of life and outcomes than early-stage diagnoses.

Two Black female co-founders are on a mission to solve this problem.

"The cancer research community has made great strides in cancer prevention and treatment," said Olufunmilayo (Funmi) Olopade, MD, Co-founder and Chief Scientific Advisor of CancerIQ. "But now we must accelerate and scale the clinical pipeline, so a diverse population of patients — those receiving care at academic medical centers and community hospitals alike — can benefit from these advances." Dr. Olopade served on the National Cancer Advisory Board and is one of the field’s foremost authorities on cancer genetics and precision oncology.

"CancerIQ’s vision is to end cancer as we know it by eliminating health disparities and democratizing access to the latest advances in cancer early detection and prevention," added Feyi Olopade Ayodele, Co-founder and CEO of CancerIQ. "We started by making genetic testing more accessible and connecting patients to the right preventive services at the right time. This latest round of funding will help CancerIQ reach more patients and connect to more innovations that promise to transform cancer from a deadly disease to a manageable condition."

CancerIQ’s precision health platform, which is being used by clinicians at more than 180 locations across the country, makes it easy to determine a patient’s individual risk of cancer based on family history, genetics, behavior, and other factors, and then connect them to the corresponding care pathways. Those pathways range from MRIs, prophylactic surgeries and vaccinations to at-home screening kits, multi-cancer early detection (MCED) tests, lifestyle interventions and other services such as clinical trials, educational materials, and social resources. CancerIQ is embedded directly into EMR workflows so clinicians in any care setting have the latest genomics research, clinical guidelines, and life sciences innovations at their fingertips.

"CancerIQ’s platform creates the critical infrastructure needed to bring cancer-focused precision health into the actual clinical workflow for every clinician, at every heath system," said Taha Jangda, General Partner, HealthX Ventures. "This enables clinicians across service lines to perform cancer risk stratification much sooner in the care journey, and to steer patients down a precision pathway to prevention and early detection. This is needed now more than ever given the backlog of cancer screenings from the pandemic."

The new funding will help CancerIQ grow its precision health platform, strengthen its partnership ecosystem, and expand its health system network. Following a recent series of key executive hires, the company also plans to hire 50 team members to meet the rising demand for more efficient and innovative cancer prevention services.

"CancerIQ is poised to address a critical need in cancer care. Through early detection and addressing health care disparities, it is possible to provide patients better access to today’s innovations" said Joel Krikston, Managing Director and Head of Strategic Innovation Alliances, Merck GHI Fund. "We are committed to partnering with innovative companies to improve the quality of health outcomes for all patients, and we look forward to furthering this mission with CancerIQ."

On March 3, 2022 Known Medicine, a rising biotechnology powerhouse aimed to discover new cancer drugs, reported a partnership with Duke University to predict drug efficacy for lung cancer patients (Press release, Duke University, MAR 3, 2022, View Source [SID1234609492]). This collaboration will enable Known Medicine to optimize and validate their novel ODINTM platform. Duke University collaborator, Kamran Mahmood, MD, MPH, is the lead collaborator on this initiative. Together, Known Medicine and Duke University aim to determine if Known Medicine’s novel platform can be used to predict actual clinical outcomes in 75 patients.

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"We are incredibly grateful for the opportunity to partner with Dr. Kamran Mahmood and the greater Duke University community. As one of the leading cancer institutes in the country, this partnership allows us to generate clinical, biological, and computational insights to improve cancer patient lives," said Andrea Mazzocchi, PhD, CEO and co-founder at Known Medicine.

"This collaboration with start-up Known Medicine will enable clinicians to provide personalized therapy to their patients. We are excited to be part of the Known Medicine community and look forward to future collaborations and projects to improve patient care and treatment for lung cancer," said Mahmood, Associate Professor of Medicine at Duke.

Known Medicine generates thousands of 3-dimensional (3D) micro-tumors from a single patient tumor or malignant pleural effusion sample. Each micro-tumor is then treated with a different drug or combination of drugs. High-content images are obtained and analyzed to observe the response to treatment and identify the best treatment for each cancer.

Known Medicine is able to take the experiment out of the patient by testing hundreds of drugs in parallel on their micro-tumor platform while observing how the patient-specific cancer cells respond. Their machine learning-based analysis relies on high-content images of these 3D micro-tumors to better understand why cells respond to one treatment over another. Functional outcomes are combined with high dimensional -omics datasets to identify the best patients for existing drugs, and the best potential new drug candidates.

On March 3, 2022 Median Technologies (ALMDT) reported that the company has filed a 513(g) submission on Feb. 17, 2022 to the United States Food and Drug Administration (FDA) for its iBiopsy Lung Cancer Screening (LCS) AI/ML technology-based end-to-end CADe/CADx1 Software as Medical Device (SaMD) (Press release, MEDIAN Technologies, MAR 3, 2022, View Source [SID1234609491]).

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The 513(g) submission will allow Median Technologies to determine the best product classification and choose between the De Novo or the 510(k) regulatory pathways for iBiopsy LCS CADe/CADx SaMD. The FDA is expected to review the 513(g) submission and provide feedback within 60 calendar days.

As next regulatory steps, Median Technologies is preparing several Q-submissions for Q2, 2022.

"This first regulatory submission marks the beginning of our interactions with the FDA. The FDA’s feedback will help us determine the shortest and most efficient way to bring our product onto the US healthcare market", Fredrik Brag, CEO and founder of Median Technologies said. "Lung cancer is the deadliest cancer, and being able to detect it very early is of critical importance for patients. Our innovative iBiopsy AI/ML-based technology could have a huge impact on saving patients’ lives by identifying lung cancer onsets at their earliest stage, and could significantly improve the accuracy, consistency, and adoption of lung cancer screening programs worldwide".

About iBiopsy: iBiopsy is based on the most advanced technologies in Artificial Intelligence (AI) and Data Science (DS), benefiting from Median’s expertise in medical image processing. iBiopsy targets the development of innovative AI/ML-based Software as Medical Device, to be used in several indications for which there are unmet needs regarding early diagnosis, prognosis and treatment selection in the context of precision medicine. iBiopsy currently focuses on lung cancer, liver cancer (HCC) and liver fibrosis (NASH).

On March 3, 2022 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that its Chairman and Chief Executive Officer, Kevin Hrusovsky will present virtually at The Cowen 42nd Annual Health Care Conference on March 9, 2022 at 9:50 a.m., EST. To register for the live webcast, please visit: https://wsw.com/webcast/cowen108/qtrx/2066139 (Press release, Quanterix, MAR 3, 2022, View Source [SID1234609490]).

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Hrusovsky will also host virtual one-on-one meetings with institutional investors on Tuesday, March 8 and Wednesday, March 9. A live webcast of the conversation will be available on the investor section of the Quanterix website at View Source Replays of the webcast will be available on the Quanterix website for 90 days following the conference.

On March 3, 2022 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported that a new, wholly owned subsidiary of Lucid, LucidDx Labs Inc. ("LucidDx Labs") has acquired from ResearchDx, Inc. ("RDx"), a CLIA-certified, CAP-accredited clinical laboratory operator located in Irvine, CA, certain licenses and other related assets necessary for LucidDx Labs to operate its own new CLIA-certified, CAP-accredited clinical laboratory located in Lake Forest, CA (the "Laboratory") (Press release, Lucid Diagnostics, MAR 3, 2022, View Source [SID1234609489]). RDx had performed Lucid’s EsoGuard Esophageal DNA Test ("EsoGuard") since its transfer from a university research laboratory and its commercial launch as a Laboratory Developed Test ("LDT"). LucidDx Labs has begun performing EsoGuard testing at the Laboratory, including DNA extraction and bisulfite-converted next-generation sequencing ("NGS"), on surface esophageal cells collected using Lucid’s EsoCheck Esophageal Cell Collection Device ("EsoCheck") from at-risk patients with Gastroesophageal Reflux Disease ("GERD"), also known as chronic heartburn or acid reflux.

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"This critical milestone is the culmination of a lot of highly collaborative work over the past few months by our team and our outstanding partners at ResearchDx"

"This critical milestone is the culmination of a lot of highly collaborative work over the past few months by our team and our outstanding partners at ResearchDx," said Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. "Having our own CLIA/CAP laboratory to perform EsoGuard testing will markedly streamline and simplify numerous important processes, including EsoGuard billing and collections. More fundamentally, it provides us with a strong, long-term, scalable infrastructure to accommodate accelerating growth in testing volume from our expanding EsoGuard commercialization activities."

LucidDx Labs and RDx also entered into a management services agreement pursuant to which RDx will continue to provide personnel and services to support the performance of EsoGuard at the Laboratory. Concurrently, LucidDx Labs entered into an agreement to lease the building in Lake Forest, CA where the Laboratory operates from an affiliate of RDx. The Laboratory has acquired, installed, and qualified all the necessary technology and equipment to perform the EsoGuard assay, completed the necessary assay validations to process clinical samples as an LDT, completed a College of American Pathologists ("CAP") audit, and begun performing EsoGuard testing at the new facility. Protocols to initiate formal transfer of the Clinical Laboratory Information Act ("CLIA") certificate as well as relevant state licenses have commenced. Further details on this acquisition and the launch of the laboratory can be found in a Current Report filed today with the Securities and Exchange Commission on Form 8-K.

About EsoGuard and EsoCheck

Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer ("EAC"). Over 80% of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer, which occurs in approximately 5% to 15% of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.

Esophageal precancer screening is already recommended by clinical practice guidelines in millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, fewer than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment.

The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard and EsoCheck are the missing element and constitute the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through the early detection of esophageal precancer in at-risk GERD patients.

EsoGuard is a bisulfite-converted NGS DNA assay performed on surface esophageal cells collected with EsoCheck which quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient, multicenter, case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and cancer.

EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. Lucid believes this proprietary Collect+Protect technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express mail to Lucid’s third-party CLIA-certified laboratory partner for EsoGuard testing.