Research & Development
Tempus launching liquid biopsy panel
The company said it will initially make the test available on a limited scale along with its xF 105-gene liquid biopsy assay and conduct a broader launch later in 2022.
June 5, 2022
Study revises thinking on genes and breast cancer risk
The review incorporates the findings of the Cancer Risk Estimates Related to Susceptibility (CARRIERS) consortium, a group evaluating predisposition genes and the incidence of breast cancer. Drawing from U.S. population studies, researchers evaluated hereditary cancer genetic testing for 12 established breast cancer genes in a total of 32,247 women with breast cancer and 32,544 women without breast cancer. Results were published by Fergus Couch, PhD, a consultant in experimental pathology and laboratory medicine at the Mayo Clinic, and colleagues.
January 21, 2021
Healthy Nevada Project: Community genetic testing needed
The study, conducted by researchers from the Healthy Nevada Project, focused on identifying carriers of hereditary breast and ovarian cancer, Lynch syndrome, and familial hypercholesterolemia.
July 28, 2020
Myriad partners with OptraHealth on cancer chatbot
Gene includes OptraHealth's GeneFax artificial intelligence (AI) platform that helps it answer more than 500,000 questions about hereditary cancer. It works with Myriad's online hereditary cancer quiz, the company said. For potential patients who meet criteria for further evaluation, Gene will send an educational link that directs users to interactive content for further education and the option to talk with a patient educator.
July 5, 2020
Myriad homes in on CHEK2 carriers' varied breast cancer risk
The study involved multigene panel testing of 358,741 women with hereditary cancer risk for breast cancer, of whom 4,331 carried CHEK2 mutations. The CHEK2 subset was integrated into the company's polygenic risk score in combination with known risk factors; results were compared with an independent cohort of 459 women.
June 1, 2020
How to manage genetic testing of pancreatic cancer patients
The National Comprehensive Cancer Network recently recommended germline testing for all people newly diagnosed with pancreatic ductal adenocarcinoma (PDAC). Also, the American Society of Clinical Oncology has issued a clinical opinion advising risk assessment and consideration of germline testing for all patients newly diagnosed, Dr. Eileen O'Reilly, an oncologist at Memorial Sloan Kettering Cancer Center, and colleagues observed. But opinions on what, exactly, to test for have been divided, and guidance has been lacking, they suggested in JAMA Oncology.
February 13, 2020
Chembio Diagnostics applies for FDA CLIA waiver for HIV, syphilis test
Dr. Fauci invokes Yogi Berra to describe emerging infectious disease challenge
Thermo Fisher Scientific introduces digital PCR liquid-biopsy assays for academic, clinical research
Thermo Fisher Scientific updates Applied Biosystems genetic analyzers to comply with IVDR
Week in Review: Elizabeth Holmes sentenced; good cholesterol worse for some adults; earlier type 2 diabetes diagnosis; and more
Quest Diagnostics completes acquisition of Summa Health outreach lab services business
Is the new Medicare NGS payment policy really a win for patients?
The implications of the new policy, however, are less positive than what appears at the surface. Patients seeking germline testing are only slightly better off now than they were two years ago, before the NCD was initiated.
February 4, 2020
CMS broadens coverage for NGS tests in breast, ovarian cancers
In a decision memo issued January 27, CMS announced that it will be covering NGS tests that are cleared or approved by the U.S. Food and Drug Administration (FDA) for some patients. The agency explained that its coverage determination applies to patients who have breast or ovarian cancer, as long as the patient has a risk factor or clinical indication for germline (inherited) breast or ovarian cancer and has not been previously tested with the same test for the same germline genetic content.
January 26, 2020
Myriad opens hood on carriers of breast cancer risk genes
The company currently offers hereditary cancer testing for women to determine their risk for breast cancer, with analysis/results based on mutation status. Those with high-risk or intermediate-risk mutations -- BRCA1, BRCA2, ATM, CHEK2, and PALB2 -- are notified that they are carriers. Those who do not test positive for genes with intermediate or high risk are given a polygenic risk score (PRS) for developing breast cancer based on testing for 86 single nucleotide polymorphisms (SNPs).
December 16, 2019
CVS Health paves way for genetic testing of cancer patients
The program -- dubbed Transform Oncology Care -- revolves around a web-based prescribing portal that will direct oncologists to gene panel testing through partner Tempus, which provides a broad range of DNA and RNA sequencing services. It will be enabled through the company's CVS Caremark pharmacy benefit manager subsidiary and is now open to patients enrolled in Aetna commercial insurance plans in 12 U.S. states. The program will also be marketed to other insurance companies.
December 11, 2019
CMS plans broader coverage for NGS in breast, ovarian cancer
The agency's review and terms and conditions on the matter were published on October 29 in a proposed national coverage determination (NCD). The agency advised coverage for next-generation sequencing with physician-ordered companion diagnostic tests approved or cleared by the U.S. Food and Drug Administration (FDA) and performed in a CLIA-certified lab. Patients must meet a range of conditions, according to CMS. They must have ovarian or breast cancer, have clinical indications for testing for hereditary cancer, and have never received a prior NGS test. Results will be provided to the treating physician.
October 29, 2019
RNA testing clarifies the unknown in Ambry cancer study
Earlier this month, the company announced the launch of its +RNAinsight paired testing for RNA and DNA for genes associated with hereditary cancers. The idea is that testing for both provides more information for determining cancer risk.
October 24, 2019
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