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Psomagen Incorporated and Kean Health Vaginal Microbiome Tests

Contract lab services provider Psomagen Incorporated and Kean Health, an at-home health testing service, have launched two vaginal microbiome tests, called Kean V and Kean V+.

The tests provide health insights by categorizing a sample into one of five vaginal types defined by their Lactobacillus bacterial balance. The V+ test adds additional testing for the sexually transmitted infections gonorrhea, chlamydia, human papillomavirus, and Mycoplasma genitalium. V+ was developed in conjunction with digital genetic counseling company, DNAvisit and includes an optional consultation with a DNAvisit clinician for users who test positive for STIs.

Takeda, Prometheus Laboratories CDPath Test

Takeda and Prometheus Laboratories have jointly launched the CDPath prognostic test for Crohn's disease. The risk assessment test is used with a physician's clinical assessment to evaluate an individual's likelihood for developing serious complications of Crohn's disease, such as bowel strictures, internal penetrating disease, or non-perianal surgery within three years. The test is for adults at least 18 years old who have been diagnosed with Crohn's disease during the past 10 years and who have not experienced serious complications. CDPath is used with a blood sample and integrates serologic biomarkers and genetic marker status with a patient's Crohn's disease characteristics to predict a low, medium, or high risk for developing serious complications during the next three years.The test was developed through a collaboration among Takeda, Prometheus, and MiTest Health. Prometheus has received approval from the New York State Department of Health to market CDPath as a laboratory-developed test. 

Innovative Health Diagnostics Anti-Mullerian Hormone Test, COVID-19 Antibody Test

Innovative Health Diagnostics it has launched the at-home anti-Mullerian hormone test and the at-home COVID-19 neutralizing antibody test. The anti-Mullerian hormone test measures the level of the hormone in an individual's body, providing a range for comparison, to indicate her ovarian reserve. The testscosts $99. The COVID-19 test detects neutralizing antibodies against the SARS-CoV-2 virus in a person in response to the disease, either from a vaccination or infection. The test costs $85.

Apis Assay Technologies Breast Cancer Subtyping Kit

The UK-based company Apis Assay Technologies is launching its Breast Cancer Subtyping Kit as an in vitro diagnostic in the UK and for research use only in other geographies. The RNA-based diagnostic workflow can be used to detect mRNA expression of standard biomarkers (ER, PR, HER2, Ki67) and novel proliferative biomarkers from pre-operative core-needle biopsy or resected FFPE breast tumor tissue. The assay addresses several unmet needs in current practice, including a faster HER2 result turnaround without the need for reflex testing when the IHC result is unclear; higher accuracy of the Ki67 proliferation measurement; and significantly reduced time for results interpretation, the company said. The assay will also be accompanied by validated software for automatic results interpretation, Apis said.

Cue Health Cue Care

Cue Health has launched its Cue Care service via its Cue Health application, which allows users who test positive for COVID-19 using Cue's tests to consult virtually with a healthcare provider about their test result and obtain a prescription for medication, if needed, to treat the virus. Users can get the prescription delivered to their homes or pick it up from a pharmacy. Cue said that within a few weeks, the service will be expanded to people who test positive on any COVID-19 test, including an at-home antigen test. The service costs between $79 and $99 and includes the telehealth visit and delivery of the medication. 

Roche Digital LightCycler System

Roche has launched the Digital LightCycler System, which can divide DNA and RNA from an already extracted clinical sample into as many as 100,000 microscopic individual reactions on which PCR is then performed. The system is designed for laboratories performing highly sensitive and precise DNA and RNA analysis in areas such as oncology and infectious diseases. Applications include the detection of ultra-rare targets, accurately quantifying how much target DNA or RNA is present at a molecular level, and other high-precision analysis, Roche said. The system will be available in 15 countries worldwide in 2022 with plans to launch into more countries in the near future. It will also be CE-marked and has 510(k) exempt status from the US Food and Drug Administration, Roche noted.

Immunexpress SeptiCyte Rapid EDTA Blood-Compatible Cartridges

Immunexpress has launched new SeptiCyte Rapid EDTA blood-compatible cartridges for the European market. The updated cartridges add undiluted EDTA blood as a validated sample type. According to the Seattle-based firm, EDTA blood collection tubes are used routinely in clinical settings for hematology procedures globally. Validation of the cartridges for use in the US, and studies for 510(k) clearance by the US Food and Drug Administration are expected to be finished in the fourth quarter of this year.

Boston Heart Diagnostics LipidSeq

Boston Heart Diagnostics, a Eurofins company, has launched the LipidSeq genetic test for cardiovascular disease. A saliva-based, 23-gene, next-generation sequencing test, LipidSeq identifies the most common genetic causes of lipid and lipoprotein disorders associated with premature cardiovascular, pancreatic, kidney, and neurological diseases. Specific conditions detected by the test include familial forms of hypercholesterolemia, lysosomal acid lipase deficiency, sitosterolemia, cerebrotendinous xanthomatosis, dysbetalipoproteinemia, hypertriglyceridemia, and HDL deficiency states including ApoA-I deficiency, Tangier disease, and LCAT deficiency.

LipidSeq was developed in collaboration with Eurofins laboratory partner Clinical Enterprise, which performs the genetic sequencing, and in consultation with Robert Hegele of Robarts Research Institute in London, Ontario.

GenScript Monkeypox PCR Kit

GenScript USA, a subsidiary of GenScript Biotech Corporation, has launched a monkeypox assay kit. The qualitative PCR test amplifies two conserved genetic regions of the monkeypox virus, with pseudovirus validation control available separately. It can be ordered by diagnostic labs and medical device distributors to be used in research for the detection of the monkeypox virus. The test kit has also obtained the CE mark for IVD use in the European Union.

Quest Diagnostics Hepatitis C Obstetrics Test

Quest Diagnostics has released a new obstetrics laboratory test panel that includes an assay for hepatitis C (HCV). The test uses HCV antibody testing with reflex to quantitative real-time PCR. According to Quest, the inclusion of an HCV assay in the panel will improve uptake of HCV screening in pregnant patients, which has lagged behind testing for other diseases like HIV, HBV, and syphilis that are part of standard obstetric testing panels.