List of Diagnostics Companies in North Carolina - 14

Advanced Biological Laboratories (ABL), S.A., is a Medical Data Technology company founded in 2000 as a spin-off from CRP-Santé Luxembourg. ABL acquired all the patents and IP rights from TherapyEdge, Inc. in 2005 and in 2013 acquired the rights to all viral hepatitis B & C related assets from EVIVAR MEDICAL, respectively. ABL has a comprehensive suite of healthcare management products, including TherapyEdge®, ViroScore®, SeqHepB, DeepChek®, VisibleChek®, HepatiC™ and the DPM which are used for data and patient management, monitoring and personalized reporting applications. COVID-19: CE mark (07/2020)

AccuGenomics is a biotechnology company that specializes in a unique spike-in control technology to enhance the accuracy of clinical sequencing tests for low abundance biomarkers and infectious pathogens.

Develops a rapid leukocyte differential instrument is used to screen for infections, allergies, and blood-related cancers including leukemia.

Baebies Inc. is a growth-stage medical device company developing innovative products to enable early disease detection and multifunctional diagnostics for syndromic testing for children and adults. Guided by the vision that everyone deserves to be healthy, we aim to deliver ‘Any test. Anywhere. To Everyone.’ We deliver millions of tests globally every year to save lives and make lives better. Baebies is a pioneer in digital microfluidics technology, which maximizes diagnostic yield from low-volume samples. Baebies is headquartered in Durham, North Carolina, and our products are used in central laboratories and point-of-care settings around the world. Over 20 million tests delivered, and counting. Every test is a chance to save a life. Our current pipeline of test panels on the multifunctional FINDER platform include molecular (Respiratory panel - Flu A, Flu B, RSV, and SARS-CoV-2, STI panel - CT/NG/TV), coagulation (anti-factor Xa, aPTT), and chemistry (G6PD).

Biofidelity is a rapidly growing commercial-stage genomic technology company dedicated to bringing the benefits of precision medicine to patients around the world. We have launched our first product, ASPYRE-Lung, in the US and we have an extensive pipeline of novel products. Biofidelity has developed a novel molecular biology technology which enables genomic analysis for cancer diagnosis to be carried out locally, quickly and far more cost-effectively.

Domus Diagnostics is working to create infectious disease diagnostic tests that are affordable, user-friendly, accurate, and rapid enough to address the needs raised by current and future public health crises.

We offer advanced diagnostic test solutions that GO BEYOND the limits of detection for low-abundance flea and tick-borne infections, such as bartonellosis and Lyme borreliosis. Our recently launched Nanotrap Urine test is a more sensitive direct detection test method for confirming Lyme disease diagnoses. Learn more on our website.

GeneCentric was founded based on intellectual property from Drs. Neil Hayes and Chuck Perou's laboratories at the Lineberger Comprehensive Cancer Center at the UNC School of Medicine. GeneCentric currently has two unique platform technologies: The Lung Subtype Platform (LSP™) stratifies lung cancer patients into subtypes, which are important for appropriate therapeutic selection. The first application of LSP™ was licensed to and independently developed by Laboratory Corporation of America® Holdings ("LabCorp") and is now available through its specialty testing business, Integrated Oncology, as HistoPlusSM: Lung Cancer. GeneCentric's second platform technology is the Hypoxia Signature which has the potential to identify patients that respond to anti-angiogenesis therapies. GeneCentric utilizes a unique partnership model to translate important cancer discoveries into clinically adopted diagnostics for pathologists, clinicians, and, most importantly, patients. By partnering with the foremost clinical laboratories, in-vitro diagnostic (IVD), pharmaceutical, and biotech companies, GeneCentric can focus on its core strength, exceptional science and clinical studies, building evidence for the utility of its unique assays.

HemoSonics is breaking new ground in point-of-care Viscoelastic #hemostasis testing. When time is critical, the Quantra® QPlus® System offers rapid, accurate, and easy to understand results that enable clinicians to make more informed #transfusion decisions, more quickly. This novel, cartridge-based POC VET system now has De Novo marketing authorization in the USA and is intended to assess the coagulation status of perioperative patients at the point of care. Follow us at @HemoSonics

Almost every factor that affects health – from genetics and the microbiome to disease and lifestyle – exerts its influence by altering metabolite levels in the body or other biological system. By producing the most accurate and comprehensive picture of the collection of metabolites, known as the metabolome, from a single biological sample, Metabolon can deliver an instantaneous snapshot of the entire physiology of a living being at a discreet point in time, as well as identify changes in that system brought about the impact of disease, medical intervention, diet or the environment. This deep and comprehensive view of the metabolome provides biological insights that cannot be revealed through any other research methodology, enabling life sciences researchers and drug developers to discover answers some of biology’s most difficult questions. Metabolon's unrivaled capability to look deep into the metabolome has enabled us to build the world’s largest library of compounds that currently includes 5,200+ total known molecules. Our proprietary Precision Metabolomics™ platform, combined with the world's most experienced metabolomics scientists, delivers biologic insights and identification of novel commercial opportunities for drug discovery and development, through clinical trials and life cycle management. Metabolon’s expertise is also accelerating research and product development for clients in academia, population health, consumer products, and nutrition industries. Founded in 2000 and based in Research Triangle Park, North Carolina, Metabolon has conducted more than 10,000 independent and collaborative studies, resulting in 2,000+ publications in leading peer-reviewed journals. For more information about our technology, products and services, please visit www.metabolon.com.

OncoTAb, Inc., a North Carolina based biotechnology company, was founded by Mayo Clinic alumna Dr. Pinku Mukherjee, with a mission to improve the quality of cancer care by addressing unmet cancer diagnostic and therapeutic needs. The company has just launched its first product: Agkura™ Personal Score – a simple, non-invasive blood test that aids breast cancer detection in women with dense breast tissue. Roughly half of the women in the US have dense breast tissue and mammograms miss 50% of the breast cancers in these women, resulting in late stage diagnosis and mortality. Agkura™ Personal Score measures the biomarker tumor-associated MUC1 (tMUC1) and shows a trend of increasing value from benign disease through breast cancer stages 1 to 4. Women can monitor their personal score in conjunction with annual mammograms. A score above the normal range or an increase greater than normal variation will trigger a recommendation for diagnostic imaging (ultrasound or MRI), resulting in earlier stage diagnosis of breast cancer. The company is also working on developing treatments for breast and pancreatic cancers.

Sapere Bio is a longevity technology company. SapereX, a blood-based measure of cellular senescence and immune function, captures fundamental mechanisms of aging. SapereX allows clinicians and scientists to see early aging and monitor how interventions aimed to increase healthspan are working in individual patients. We are changing the way aging is measured and imagined, for longer healthspan and better lives. Sapere Bio was co-founded by Dr. Norman Sharpless, former Director of the NCI, and Dr Natalia Mitin, current CEO of Sapere Bio.

Developing next generation technologies for precision medicine and drug discovery.