In the rapidly-evolving space of diagnostics, a few companies are leading the charge with innovative solutions. ENMEDIA highlights key players to watch.
AcuamarkDx is a cancer diagnostics company making early cancer detection the new standard of primary care. Frequent monitoring and screening are the standard of care for diseases such as diabetes and heart disease. Why can’t this be true for cancer? At present, no early cancer diagnostic is both sensitive and specific. The AcuamarkDx technology uses optimized qPCR to detect low-abundance methylation markers, allowing for both sensitive and specific detection of cancer at early stages. The company’s initial product will focus on colorectal cancer, with a pan-cancer screening test to follow. With the implementation of its tests, AcuamarkDx hopes to prevent 5 million cancer deaths annually by providing earlier cancer detection for all.
Immunis.AI is an immunogenomics company developing a new category of biopsy technology for prostate cancer patients in active surveillance. Their blood-based biopsy technology is designed to replace invasive prostate biopsies to stratify patients’ risk for developing clinically significant prostate cancer. By harnessing the power of the immune system, the technology creates a personalized immune profile for each patient, indicating whether the patient’s cancer is indolent or aggressive. This technology will provide patients and providers with a non-invasive and effective technology to better inform decisions about entering, continuing or stopping active surveillance protocols.
In 2014, Exact Sciences, the leading provider of cancer screening and diagnostic tests, launched its well-known and revolutionary Cologuard® test. A non-invasive screening tool for colorectal cancer, it has significantly improved early detection rates.
But the company’s newest test, OncoExTra™ is poised for big impact. It is already helping to advance timely, shared cancer treatment decision making with ultra-comprehensive genomic profiling that detects cancer by interrogating both DNA and RNA signals. OncoExTra generates a report highlighting insights, such as mutations and fusions, immune-oncology signatures and clinical trial options.
Stephen Gruber, MD, PhD, MPH, Vice President of the City of Hope National Medical Center and Director, Center for Precision Medicine at City of Hope, said in a press release about the test’s launch in February, “With this test, I have a much better picture of my patient’s cancer, allowing me to prescribe the most effective treatment for their specific solid tumor.”
Linear Diagnostics is a pioneer in the area of point-of-care diagnostic testing. Linear’s platform technology, EXPAR, focuses on the rapidly growing market of sexually transmitted infections. EXPAR is a rapid response, near-patient diagnostic that utilizes a novel linear dichroism technology, enabling the rapid detection of multiple targets using a disposable cartridge run on a small low-cost instrument. Their dual test for Chlamydia trachomatis and Neisseria gonorrhoeae will detect gene sequences highly specific to these organisms, with linear dichroism providing significant advantages in terms of sensitivity and a faster time-to-result than existing solutions.
Baebies is a diagnostic company focusing on the most innocent and precious people among us: newborns. The company was thrust to the forefront of the diagnostics space in 2020 when it was awarded the Disruptive Technology award by the American Association for Clinical Chemistry. When a baby is born, first and foremost, parents want to know the newborn is healthy. The technology, called FINDER®, is a revolutionary near-patient testing instrument that operates on only 50 microliters of blood and provides results in just 15 minutes. FINDER currently tests for Glucose-6- Phosphate Dehydrogenase Deficiency, providing quick answers and peace of mind for new parents at bedside minutes after birth.