Ovarian Cancer Companion Diagnostic Tests In 2019, the BRCA1 and BRCA2 Gene Mutation Detection Kit (Reversible Terminator Sequencing) of Xiamen Amoy Diagnostics Co., Ltd. was approved. It is intended for the qua..

Original from: Roche · Group sales grew by 7% at constant exchange rates (CER; 3% in CHF), driven by strong demand for both medicines and diagnostics. · Excluding COVID-19, Group sales increase..

Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, today announced it has completed its previously announced acquisition of select assets of University Hospitals, one of the nation's leading nonprofit health systems and academic medical centers. Financial terms were not disclosed.

PinkDx, Inc., an early-stage company focused on positively impacting the health of women throughout their life journey, today announced that it has completed a second close of its previously announced Series A financing, raising an additional $5 million, including from new investors Blue Venture Fund, Sandbox Clinical Ventures and BEVC. This brings the total raised in the upsized round to $45 million. The funding will help PinkDx further advance its first test, which is intended to clarify diagnosis for women presenting with a potential gynecologic cancer.

Leica Biosystems, a cancer diagnostics company and a global leader in workflow solutions, and Molecular Instruments® (MI), the inventor of the HCR™ Imaging technology, today announced a partnership to enable fully integrated RNA-ISH using the BOND RX and BOND RXm research staining systems.

Medix Biochemica, a global leader in the supply of critical raw materials for the in vitro diagnostics (IVD) industry, announced the acquisition of CANDOR Bioscience GmbH, a Germany-based developer and manufacturer of premium immunoassay solutions. The acquisition both strengthens Medix Biochemica’s range of high-quality raw materials to the worldwide IVD industry and enhances its capabilities to support test manufacturers in immunoassay development. Following the transaction, CANDOR Bioscience’s high-quality operations will remain in Wangen im Allgäu, Germany.

Abbott is well known for its distinctive mix of growth and stability – simultaneously innovating healthcare’s next chapter and delivering strong growth as it returns value to shareholders – and the fourth quarter was no exception.

Inflammatix, a pioneering host response diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the TriVerity™ Test System (TriVerity), a first-in-class molecular test for patients with suspected acute infection or sepsis. Using precise measurements of a patient’s immune response, TriVerity combines highly accurate bacterial-viral infection scoring with an all-cause illness severity risk evaluation, giving clinicians a rapid and holistic snapshot of a patient’s status.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas® liat sexually transmitted infection (STI) multiplex assay panels. These panels, including tests for chlamydia and gonorrhea (CT/NG) and chlamydia, gonorrhea and Mycoplasma genitalium (CT/NG/MG), enable clinicians to diagnose and differentiate between multiple STIs with a single sample. These tests will be exclusively available in the U.S. market in the coming months, with commercialisation under CE mark expected to follow shortly.

3.3 Tumor Companion Diagnostic Reagents Non-small Cell Lung Cancer Companion Diagnostic Tests High-throughput sequencing (HTS) has started to be applied in tumor companion diagnosis in recent years..

Danaher and Fudan University’s Huashan Hospital Partner to Develop Alzheimer’s Diagnosis Technology On January 20, Danaher, a global leader in science and technology innovation, announce..

Omics firm Sapient said Wednesday that it has partnered with Alamar Biosciences to provide proteomics services using Alamar's NULISA multiplexed immunoassay platform.

Teal Health, a women’s health company on a mission to eliminate cervical cancer in the US, announced today the close of an additional $10 million in seed funding to support the upcoming launch of the Teal WandTM, which is currently under FDA review and on track to be the US market's first FDA-approved at-home self-collect cervical cancer screening device. This new capital brings Teal Health’s funding to $23 million to date as the company accelerates its product development and readies go-to-market plans.

Kryptos Biotechnologies said this week that the Research Investment for Global Health Technology (RIGHT) Foundation has awarded it $1.2 million to further develop its molecular diagnostic testing system for use at the point of care.

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Day One Biopharmaceuticals’ OJEMDA, a type II RAF inhibitor, for the treatment of patients six months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. FoundationOne CDx is the first and only companion diagnostic for OJEMDA.