Sentences with phrase «diagnostic testing companies»

Draft compliance policies for genetic testing and laboratory services pharmaceutical, biotech, medical device and diagnostic testing companies.

Not exact matches

Holmes and Theranos made waves in Silicon Valley and the diagnostics industry two years ago, when investors lined up to boost the valuation of a company that claimed it would soon offer more than 1,000 varieties of blood diagnostics tests without the need for a syringe.

Diversified healthcare company Abbott Laboratories on Friday agreed to buy Alere for about $ 4.48 billion, ending a prolonged legal battle over its plan to buy the diagnostic - testing company.

We're seeing diagnostics companies use AI to create new tests that have much higher accuracy, much lower cost, and typically diagnose things much earlier.

Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward - looking statements include, among others, the following: our ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and healthcare providers; our ability to meet demand for our products and services; the willingness of health insurance companies and other payers to cover Cologuard and adequately reimburse us for our performance of the Cologuard test; the amount and nature of competition from other cancer screening and diagnostic products and services; the effects of the adoption, modification or repeal of any healthcare reform law, rule, order, interpretation or policy; the effects of changes in pricing, coverage and reimbursement for our products and services, including without limitation as a result of the Protecting Access to Medicare Act of 2014; recommendations, guidelines and quality metrics issued by various organizations such as the U.S. Preventive Services Task Force, the American Cancer Society, and the National Committee for Quality Assurance regarding cancer screening or our products and services; our ability to successfully develop new products and services; our success establishing and maintaining collaborative, licensing and supplier arrangements; our ability to maintain regulatory approvals and comply with applicable regulations; and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10 - K and our subsequently filed Quarterly Reports on Form 10 - Q.

The company's Gene - RADAR system can be used at the actual hospitals where patients go; it's portable, making it an especially convenient system for Zika virus testing since blood samples don't have to be shipped off to diagnostic labs.

The Company also has a diagnostic business based on its DPNCheck ® product, which is a point - of - care test that provides accurate and cost - effective screening, diagnosis and monitoring of diabetic peripheral neuropathy (DPN).

Theranos is a diagnostics company with fast finger - prick blood testing technology that aims to upend the traditional health care establishments by making it easier, less expensive and less uncomfortable to get tested for various conditions.

Proteocyte Diagnostics is a Canadian molecular diagnostics company that has developed a novel diagnostics test, Straticyte ™ that objectively and accurately detects precancerous oral lesions at high risk of becoming cancerous.

Founder Elizabeth Holmes, who is facing a two - year ban by U.S. regulators from running a clinical testing company, used the session at the American Association for Clinical Chemistry's annual scientific meeting to introduce the «miniLab» testing device, a 95 - pound diagnostic tool that can fit on a tabletop.

Drug developer Loxo Oncology said on Tuesday it is partnering with genetic testing company Illumina Inc on a diagnostic tool that will work with Loxo's larotrectinib and another one of its experimental cancer drugs, across tumor types.

April 10 Drug developer Loxo Oncology said on Tuesday it is partnering with genetic testing company Illumina Inc on a diagnostic tool that will work with Loxo's larotrectinib and another one of its experimental cancer drugs, across tumor types.

Loxo Oncology is partnering with genetic testing company Illumina Inc to use Illumina's diagnostic tool alongside larotrectinib, the drug developer's potential blockbuster drug, the companies said on Tuesday.

About ChipCare ChipCare is a Toronto - based company producing life - saving diagnostics for infectious and non-communicable diseases in remote health settings with a mobile, simple - to - use & lab quality blood - testing platform.

Prior to joining Oberon, David was Chief Financial Officer and Treasurer at VolitionRx (NYSE MKT: VNRX), a multi-national medical diagnostics company developing simple blood - based tests to accurately diagnose a range of cancers.

April 10 Loxo Oncology is partnering with genetic testing company Illumina Inc to use Illumina's diagnostic tool alongside larotrectinib, the drug developer's potential blockbuster drug, the companies said on Tuesday.

Proteocyte Diagnostics Inc. is a Canadian molecular diagnostics company that has developed a novel diagnostics test, Straticyte ™, that accurately detects precancerous oral lesions at high risk of becoming cancerous.

Ativa Medical Corp. is a privately held, emerging growth medical diagnostic company developing and commercializing novel point - of - care diagnostic technologies.This technology will enable health care professionals to perform critical hematology and blood chemistry tests on - site and get accurate results within about 5 minutes.

The company's food diagnostics facility, located in beautiful Vermont, brings over 50 years of laboratory experience and nearly 30 years of food allergen testing expertise.

This loophole means that companies ranging from small start - ups offering just one or two tests to much larger diagnostic labs that offer thousands of tests can develop and charge for new LDTs much more easily than they can for most other categories of medical products.

«It's very surprising that the nematodes exhibited such a strong binary response to «cancer» versus «no cancer» urine,» says Michael Phillips at Menssana Research, a New Jersey - based company developing diagnostic tests based on people's breath.

Tests have been running smoothly in the lab, she notes, with some diagnostics companies already interested in the technology.

(Yesterday, the agency launched precisionFDA, a web platform for diagnostics companies, researchers, and healthcare providers to validate genetic tests against reference materials and share their results.)

There are already some companies dedicated to bringing ribozymes from the laboratory to the commercial world, with potential applications as sensitive sensors of biowarfare germs or as medical diagnostic tests.

Christian Happi at Redeemer's University in Ede, Nigeria, and the Irrua Specialist Teaching Hospital is developing a rapid diagnostic test with colleagues at Tulane University in New Orleans, Louisiana; the Broad Institute in Cambridge, Massachusetts; and Zalgen, a company in Germantown, Maryland.

The Duke team has previously explored blood tests to examine a patient's RNA for gene signatures to distinguish bacterial and viral infections in the upper respiratory tract and is working with a private company to develop potential diagnostics.

One early project was to help Genoptix — a Novartis daughter - company acquired in 2011 and located in Carlsbad, California — to commercialize a diagnostic test for lung cancer patients.

Since December 2010, WHO has endorsed the Xpert MTB / RIF test, a new molecular diagnostic manufactured by Cepheid, a company based in Sunnyvale, California.

As you don't need to make cDNA to offer a diagnostic test, campaigners for women's health hope that other companies will now leap in, and bring down the cost of testing for BRCA1 and BRCA2.

A Million dollars is on offer to the researcher or company that develops cheap and simple diagnostic tests for chlamydia and gonorrhoea.

She expects her company's first product, a diagnostic test for waterborne parasites, to reach the market by the end of 2009.

The research scientist just 4 years into her first industry job with a company that makes diagnostic tests and reagents, who finds as she reenters the job market that she is not a strong candidate for bench - science jobs in the biotech industry because she has been labeled a «diagnostics industry» employee.

Mayo had developed its own diagnostic blood test, and Mayo officials argued that although it was similar to the company's, it did not violate the principles of patent law and was medically superior.

Companies that uncover such mutations can profit by selling that knowledge to pharmaceutical companies, which can use it to develop diagnostic tests aCompanies that uncover such mutations can profit by selling that knowledge to pharmaceutical companies, which can use it to develop diagnostic tests acompanies, which can use it to develop diagnostic tests and drugs.

ISOMA is in early stage discussions with potential strategic partners to develop ISOMA Diagnostics» molecular test into a companion diagnostic that can help companies and doctors steer patients towards the right treatment choices.

Clinical laboratory geneticists primarily work in genetic testing labs that are part of either academic or research institutions, hospitals, or private diagnostic companies.

The companies will share development costs and split the profits from sales of the diagnostics tests.

Forward - looking statements include, but are not limited to: 1) the companies plan to co-develop and commercialize DNA - based diagnostic tests; 2) Illumina will gain access to disease - related biomarkers and deploy the markers into diagnostic disease panels; 3) this alliance enables us to generate near - term product revenue.

The expense and effort are increased by the FDA requirement that any company applying for approval of a drug targeted against a specific gene - driven abnormality must also produce a diagnostic test for that abnormality.

Invivoscribe Technologies Inc. is a privately held biotechnology company dedicated to improving the quality of healthcare worldwide by providing high quality, reliable, cutting - edge reagents, tests, and bioinformatics tools to advance the fields of personalized molecular diagnostics ® and personalized molecular medicine.

Esko is collaborating with Zacharon Pharmaceuticals, a San Diego - based biotechnology company, to develop a commercial diagnostic assay for differentiating forms of MPS from urine and blood samples, a screening test for newborns and a tool for measuring the biochemical response of MPS patients to existing and novel therapies.

In addition, the company collaborates with biopharmaceutical companies in the development of companion diagnostic tests and technologies for various cancer therapies, helping to realize the promise of precision oncology.

SAN DIEGO, March 28, 2017 (GLOBE NEWSWIRE)-- Invivoscribe ® Technologies Inc., a global company with decades of experience providing internationally standardized clonality and biomarker testing solutions for the fields of oncology, personalized molecular diagnostics ®, and personalized molecular medicine ®, reports that its next - generation sequencing (NGS) LymphoTrack ® Assay kits are being used by its LabPMM ® clinical laboratories, pharmaceutical partners, and cancer centers to identify and monitor chimeric antigen receptor T - cells (CAR - T) and engineered T - cell receptors in peripheral blood of subjects in support of immuno - therapeutic drug development and treatment regimen development for both hematologic and solid tumors.

The company Biomeme developed a mobile genetic diagnostic platform that features hardware used with an iPhone, software, DNA test kits and an app to provide results on the field in under an hour.

The recently - opened True Health Diagnostics laboratory, which is headquartered in Frisco, is the only company in Texas and one of only a few in the nation with a highly - advanced diagnostic technology that can detect conditions not apparent through customary diagnostic tests.

Fortunately, diagnostic testing and labwork is typically covered by insurance, and we hope that in the future more insurance companies will open their spectrum toward integrative medicine and preventative health care.

True Health Diagnostics — a Texas - based laboratory company that about two years ago acquired Health Diagnostic Laboratory in downtown Richmond and now operates HDL's former headquarters — has started offering tests for hereditary cancers.

True Health is organized to offer chronic disease diagnostics testing to physicians, who sign up for the company's services, and their patients.

To round out diagnostic testing, the company offers programs in disease prevention, wellness education, and nutritional planning.

Metametrix does the best medical diagnostic testing of any company I've come across.