New Products

Quest Diagnostics said this week it has launched an updated version of its AD-Detect blood test for helping clinicians confirm the presence of the amyloid brain pathology characteristic of Alzheimer’s disease in individuals with mild cognitive impairment or dementia. The test combines the results of blood levels of amyloid beta (AB) 42/40 as measured by mass spec and the blood levels of p-tau 217 as determined by immunoassay.

Laboratory Corporation of America said this week it has launched its pTau-217/Beta Amyloid 42 Ratio blood test for aiding the diagnosis of Alzheimer's disease. The immunoassay measures the ratio of p-tau 217 and beta amyloid 42 to determine whether an individual has the amyloid brain pathology characteristic of Alzheimer's disease. The test has sensitivity and specificity of 95 percent for detecting the presence of amyloid brain pathology, the company said.  

LetsGetChecked has launched a comprehensive hereditary cancer test that includes in-house genetic counseling and a range of multigene panels. It identifies disease-causing variants associated with hereditary cancer syndromes across multiple organ systems including breast, ovarian, uterine, gastrointestinal, endocrine, renal, skin, and brain or nervous system cancers.

Werfen is commercializing the ACL TOP Family 70 Series Hemostasis Testing Systems in North America. The systems offer centralized quality control and performance verification management, as well as automated prenalaytical checks. There are five models that accommodate all throughput needs, including the low- to medium-volume ACL TOP 370, the medium- to high-volume ACL TOP 570, and the high-volume ACL TOP 770, ACL TOP 770 S, and ACL TOP 770 LAS. All models have the same software, reagent portfolio, features, usability, and training. 

Sekisui Diagnostics has launched the Metrix COVID/Flu Test for use at the point of care and at home on the Metrix Molecular Platform. The molecular test, which returns results in 20 minutes, qualitatively detects and differentiates between RNA from SARS-CoV-2, influenza A, and influenza B from anterior nares swab samples. Sekisui inked an exclusive distribution agreement with Aptitude Medical Systems last year to sell the Aptitude Metrix COVID-19 test in the US. Now that Aptitude has received clearance from the US Food and Drug Administration for the combination test, Sekisui will also offer the combination test. 

Exact Sciences has launched Cologuard Plus, an updated version of its noninvasive, stool-based colorectal cancer screening (CRC) test. The assay is FDA-approved for average-risk patients aged 45 and older and is covered by Medicare. Exact's data, from a 20,000+ patient study called BLUE-C, indicate that Cologuard Plus detects 95 percent of colorectal cancers at 94 percent specificity in the US screening population. This translates to up to a 40 percent reduction in unnecessary colonoscopies compared to the original Cologuard assay. As Exact Sciences works to expand patient access to the new Cologuard Plus test, its original Cologuard test will remain available. 

LGC Clinical Diagnostics has launched Seraseq 22q11 Male Twins and Seraseq Euploid Male Twins reference materials for noninvasive prenatal testing (NIPT). Seraseq 22q11 Male Twins reference material is derived from a monochorionic twin pregnancy with two male fetuses diagnosed with a 22q11 microdeletion (or DiGeorge syndrome), making it ideal for NIPT assays targeting microdeletions. Seraseq Euploid Male Twins is derived from a monochorionic twin pregnancy where both fetuses are euploid, making it ideal as a negative run control.

Royal Philips has expanded its partnership with Ibex Medical Analytics and released a new version of the Philips IntelliSite Pathology Solution, a digital pathology solution that includes the full portfolio of Philips' scanners and image management system as well as Ibex's artificial intelligence-based tools for prostate, breast, and gastric cancer diagnosis. The solution has enhancements including full scan mode for the pathology SG scanner and the launch of AI and a counter marker tool in the image management system. It also includes cloud archival services that will allow laboratories to store, manage, and analyze volumes of pathology data. 

Thermo Fisher Scientific has launched the Applied Biosystems SeqStudio Flex Dx Genetic Analyzer. The capillary electrophoresis instrument is compliant with EU's In Vitro Diagnostic Regulation (IVDR) and can support both clinical as well as research for Sanger sequencing and fragment analysis in targeted genomic testing. The platform is available in both 8- and 24-capillary configurations and has a four-plate capacity. 

CareDx's donor-derived cell-free DNA (dd-cfDNA)-based AlloSure transplant health assay is now commercially available for pediatric heart transplant patients of all ages, as well as patients who have received a simultaneous pancreas-kidney (SPK) transplant. Both indications were approved by the New York State Clinical Laboratory Evaluation Program.