DiaCarta is a leading molecular diagnostics company that has developed innovative technologies to transform patient care by providing effective precision diagnostics using liquid biopsy. The company specializes in providing a comprehensive, one-stop-shop for cancer patient management solutions and offers additional testing as well. DiaCarta's proprietary XNA technology and isobDNA technology allow for sensitive, accurate, and cost-effective detection of genetic alterations using different genomic platforms. Its suite of diagnostic products and services include RadTox, ColoScape, and Oncuria and a range of infectious disease tests. DiaCarta's products and services deliver superior clinical performance and economic value, according to company officials.

The DiaCarta clinical testing laboratory at Hacienda is certified by the U.S. Clinical Laboratory Improvement Amendments (CLIA) Program, which regulates laboratories testing human specimens, and is accredited by the College of American Pathologists. As a result, clients can be assured that the company's clinical testing services meet the highest professional standards. Clients that have developed a new assay for disease detection or risk measurement use DiaCarta's clinical testing services to validate a laboratory developed test (LDT) for clinical testing use. Physicians also use the services to test patient samples for signs of disease.

Clients seeking LDT validation choose DiaCarta for a host of reasons, officials say. Since 2021, its CAP-accredited and CLIA-certified clinical lab has been located in a state-of-the-art facility at Hacienda with automated sample preparation, among other features. During the pandemic, the company ran 20,000 LDT tests daily and has extensive clinical test validation experience in serving multiple companies. Its technology know-how spans multiple technology platforms, from assay development to validation. The lab has a wide variety of testing portfolios, including cancer and infectious diseases. The company also has in-depth experience in clinical trial planning, data management, and as a contract research organization. Its regulatory compliance knowledge includes expertise in LDT services and the FDA's product approval process.

Physicians and medical practices look to DiaCarta for accurate testing of patient samples. The company's oncology tests include the RadTox test, the ColoScape test, and the Oncuria Test for bladder cancer. RadTox is designed to enable doctors to molecularly evaluate anticancer treatment response by monitoring the changes in cell-free circulating DNA  level in a cancer patient prior to and during the course of treatment. ColoScape is a multiplex real-time polymerase chain reaction (PCR) test for qualitative detection of colorectal-cancer-associated mutation and methylation markers in circulating cell-free DNA extracted from a patient's plasma samples. Oncuria, which has been designated a breakthrough device by the FDA, is a multiplex protein biomarker panel test for bladder cancer detection, monitoring, and Bacillus Calmette-Guerin (BCG) therapy prediction.

DiaCarta also offers the UTI-Detect Test for urinary tract infections. This assay provides qualitative detection of 23 bacterial, six fungi species, and six associated antimicrobial resistance genes that may be present in urine samples collected from patients suspected of having UTIs. The company has expanded its SARS-CoV2 PCR tests to include Flu A, Flu B, and RSV, with turnaround times for results ranging from the same day to the next day.

In July, DiaCarta announced that it had formed a strategic partnership with New Jersey-based Hopkins MedTech Compliance (HMC) and Hopkins MedTech Lab (HML) Services to support the unmet needs for regulatory compliance and laboratory developed test (LDT) validation of in vitro diagnostics (IVD) in the United States. The partnership will help companies who have developed novel IVD tests but do not have the capacity to bring the products for FDA approval, or to take the tests to clinical labs to serve healthcare providers and patients, company officials said.

"We are very glad to partner with HMC and HML to help more companies develop and validate LDTs for clinical testing," according to Dr. Adam (Aiguo) Zhang, CEO and President of DiaCarta. "Not only do we have successful experiences validating LDT assays for our clients, DiaCarta has also closely worked with the Centers for Medicare & Medicaid Services for coding, billing, and reimbursement of the new tests."

For more information about DiaCarta, please visit www.diacarta.com.