Quest Diagnostics QHerit Screening Service

Jul 19, 2017

Quest Diagnostic launched QHerit, a genetic screening service that tells individuals their risk of passing on heritable disorders to future generations. The QHerit Pan-Ethnic Expanded Carrier Screen provides information for 22 heritable diseases cited under new screening guidelines issued earlier this year by the American College of Gynecology. In addition to more well-known heritable disorders such as cystic fibrosis and sickle cell disease, QHerit also identifies lesser-known mutations associated with Joubert Syndrome 2 and fragile X syndrome. It also screens for spinal muscular atrophy and includes the evaluation of hemoglobinopathies.

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Nov 16, 2017

True Health Respiratory Pathogen Screening

True Health launched the respiratory pathogen screening, a single test that targets 21 viral and bacterial pathogens to help clinicians determine the correct treatment for respiratory illnesses during cold and flu season. True Health's program is built to identify the specific cause of the infection so clinicians can prescribe an effective treatment. The 21-pathogen screen has a one day turn around from receipt of the specimen at the lab to delivering the results. The screen is conducted using multiplex PCR.

Nov 15, 2017

Circulogene Microsatellite Instability Biomarker Testing

Circulogene announced the availability of microsatellite instability biomarker testing for multiple cancer types. The test is immediately available to oncologists and pathologists, enabling them to identify patients eligible for treatment with Keytruda (pembrolizumab) across multiple cancer types, or Opdivo (nivolumab) for colorectal cancer. With the new assay, Circulogene now provides circulating DNA, RNA, and MSI cancer immunotherapy testing from a single tube of blood with a three-day turnaround time out of it CLIA-certified laboratory.

Nov 15, 2017

PD-L1 IHC 28-8 pharmaDx assay

Laboratory Corporation of America announced US availability of the PD-L1 IHC 28-8 pharmaDx assay as a complementary diagnostic for two newly approved indications in connection with the use of Bristol-Myers Squibb's Opdivo. For both of the new indications – metastatic urothelial carcinoma, also referred to as bladder cancer, and squamous cell carcinoma of the head and neck – Opdivo is approved for treatment without the use of the test, but the test provides physicians with information about the patients who are most likely to respond positively to the treatment. LabCorp's Center for Molecular Biology and Pathology laboratory performed testing for the clinical studies that supported approval of the new indications for the assay. The assay was developed by Agilent's Dako pathology division. The assay was previously approved for use as a complementary diagnostic with Opdivo to treat non-squamous non-small cell lung cancer and melanoma.

Nov 14, 2017

InSource Diagnostic ToxLok

InSource Diagnostic launched ToxLok for the verification of urine-based drug tests. ToxLok uses a buccal swab along with the urine sample, and DNA markers from the swab and urine are matched. The test can identify synthetic urine and samples that may be from a friend or relative. ToxLok uses 52 genetic markers to identify each patient and urine sample. Analysis is done by qPCR and MALDI-TOF mass spectrometry. 

Nov 14, 2017

IQuity IsolateIBS-IBD

IQuity launched its IsolateIBS-IBD blood-based test for the identification of irritable bowel syndrom or inflammatory bowel disease. The Nashville, Tennessee-based company said the test can determine IBS and IBD earlier than is possible with other tests and has accuracy greater than 90 percent. It can determine whether a person's RNA profile indicates the presence of IBS or IBD, and within IBD it provides information to differentiate between Crohn's disease and ulcerative colitis. 

Nov 09, 2017

BioDiscovery NxClinical 4.0

BioDiscovery recently launched NxClinical 4.0, software for the interrogation of copy number, sequence variants, and allelic changes obtained from a single next-generation sequencing assay. The software incorporates all these genomic variations into a single database where a compound heterozygous event can easily be detected with interactive browser view and advanced filtering schemas that quickly narrow down the list of potential causal variants, the company said.

Nov 09, 2017

Ultivue InSituPlex Services

Ultivue launched its InSituPlex Services for protein biomarker expression pattern analysis in tissues. The service leverages Ultivue's technology that supports unbiased biomarker analysis at a high level of multiple and with high spatial resolution, the company said. Its service laboratory uses Leica Biosystems' Bond Rx advanced staining research platform and Leica Biosystem' Versa digital pathology scanner and associated image analysis algorithm.

Nov 09, 2017

MedReleaf ReleafDx

Canadian medical cannabis firm MedReleaf is launching in that country ReleafDx, a genetic test to help physicians in the prescription of cannabis. Based on a cheek swab, the test analyzes a patient's DNA and health conditions, providing information that a doctor can use to determine what cannabis product will work best for an individual, and the proper dosage. Dynacare, a Laboratory Corporation of America company, will manage the sample analysis and results reporting. The cheek swab can be done in doctors' offices or at a Dynacare Laboratory and Health Services Centre. The samples are then sent to Dynacare for analysis. Results are returned to the doctor with recommendations on the proper dosage of medReleaf's products. The test will be available in Canada starting in January.

Nov 08, 2017

3dbiosurfaces, Stratec Consumables 3D NS-NC slide

3dbiosurfaces and Stratec Consumables have launched the 3D NS-NC slide, a microarray substrate based on 3dbiosurfaces' technology. Stratec Consumables is a wholly owned subsidiary of Stratec. The slide offers increased signal intensity, more uniform spots, and other benefits over other microarray substrates, the firms said in a statement, adding it is especially attractive for protein applications as the surfaces allow proteins to maintain their shape and function.

Oct 31, 2017

Admera Health PGxOnco and LiquidGx Tests

Admera Health has launched two new tests: PGxOnco for cancer supportive care, and LiquidGx, a suite of liquid biopsy-based tests for tumor profiling and drug resistance monitoring. The PGxOnco test includes 50 genes and about 200 variants, and provides recommendations for over 300 drugs via next-generation sequencing. LiquidGx represents a menu of both qPCR and a NGS tests that analyze tumor DNA in blood samples. PCR assays allows for the genotyping of ALK, BRAF, EGFR, and KRAS either individually or together. The NGS panel, aimed specifically at lung cancer, includes AKT1, BRAF, ERBB2, MET, RET, ALK, EGFR, KRAS, PIK3CA,and ROS1.

Oct 24, 2017

Sygnis Universal Lateral Flow Assay Kit

Sygnis launched its universal lateral flow assay kit under the Innova Biosciences brand name. The product enables the easy and quick development of customized sandwich lateral flow assays. The kit uses Sygnis' antibody labeling technology, Ligning-Link and InnovaCoat Gold, allowing customers to create lateral flow assay reagents with just a few minutes of hands-on time, without having to spray down capture antibodies on the test strip, Sygnis said.  

Oct 23, 2017

MNG Laboratories RNA Sequencing Tests

MNG Laboratories has launched several diagnostic RNA sequencing services for patients with neurogenetic disorders. Three types of tests are available, all with turnaround times of two to four weeks: MNG Transcriptome, which provides complete transcriptome sequencing; gene-specific RNA sequencing, which includes up to five genes for investigating previously identified variants of unknown significance; and panel-specific RNA sequencing, which analyzes the expression of all genes in an NGS panel that was ordered at the same time. The tests have been validated in blood; fibroblast, muscle, and lymphoid cell lines; and nervous and brain tissue.  

Oct 19, 2017

Tempus xT Cancer Genome Sequencing Panel

Tempus has introduced Tempus xT, a genome sequencing panel that analyzes 595 genes related to diagnosis, prognosis, and therapeutic targeting of cancer. Among other things, the panel looks for single-nucleotide variants, small insertions and deletions, amplifications of copy numbers, and structural alterations that could cause fusions, the company said. Chicago-based Tempus will run the xT panel at its own next-generation sequencing lab.

Oct 16, 2017

IGeneX Lyme Disease and Tick-Borne Relapsing Fever Tests

IGeneX, a CLIA and New York-approved reference lab, launched three new tests for diagnosing Lyme disease and Tick-Borne Relapsing Fever, also known as TBRF. The Lyme ImmunoBlot IgM and IgG tests are inclusive for detection of most species of B. burgdorferi, which is one of the two groups of Borrelia that causes disease. The TBRF ImmunoBlots IgM and IgG tests are designed to detect antibodies to specific antigens of TBRF Borrelia in human serum, specifically antibodies to B. hermsii, B. miyamotoi, B. turicatae, and B. coriaceae. The Lyme IGXSpot test is an enzyme-linked immunoSpot, also known as an ELISPOT assay, which detects human T cells reactive to B. burgdorferi specific antigens.

Oct 16, 2017

Theradiag, Miraca Life Sciences Therapeutic Drug Monitoring

In vitro diagnostics and theranostics firm Theradiag said its partner Miraca Life Sciences will start marketing an eighth therapeutic drug monitoring test from Theradiag's Lisa Tracker range in the US.

Under a technology licensing agreement, Miraca will market the test, starting early in November, under the name InformTx.

Theradiag noted that an InformTx report provides clinicians with quantitative test results, historical test result data, and guidance from the most up-to-date peer-reviewed scientific literature. Testing measures the level of a specified drug as well as patient-derived antibodies to the specified drug. Miraca Life Sciences uses laboratory-validated ELISA technology for InformTx therapeutic drug monitoring, and test results are reported within five days.