Moderate Complexity Test: Page 3

NYU Langone genetic cancer test gets FDA 510(k) clearance
By LabPulse.com staff writers
Using next-generation sequencing, the test detects the DNA code changes of 607 genes linked by past studies to the development of multiple types of cancer, according to the institution. It matches the genetics of each patient's tumor cells with approved therapies targeted to specific sets of cancer-causing DNA changes, NYU Langone said.
July 28, 2021
2019 04 27 00 03 6781 Dna Sequence Shadow 400
FDA grants EUA for Diabetomics' SARS-CoV-2 Ab test
By LabPulse.com staff writers
The CovAb test only requires an oral fluid sample obtained with a simple swab of the gumline, making it easy and painless, the company said in a statement. The test is CLIA-waived, is all-inclusive, and does not require any additional components or instrumentation, Diabetomics said. Test results reportedly are available within 15 minutes.
June 23, 2021
2020 01 21 22 13 2411 Virus Coronavirus 400
NowDiagnostics gets EUA for point-of-care COVID test
By LabPulse.com staff writers
AdexusDx is designed for use in moderate-complex settings and at the point of care, according to NowDiagnostics. The company said the test can be used in a variety of CLIA-waived healthcare settings that include pharmacies, clinics, and hospital emergency rooms.
May 27, 2021
2021 05 27 23 45 4519 2021 05 28 Adexus Dx 400
FDA clears Binx Health's chlamydia, gonorrhea POC assay
By LabPulse.com staff writers
The FDA granted a waiver under the CLIA of 1988 allowing the assay to help with swift and appropriate treatment of sexually transmitted infections, Binx said.
April 1, 2021
2021 04 02 22 50 9556 Bacteria Neisseria Gonorrhoeae 400
CMS rejects Epi proColon payments, sets standards for cancer blood tests
By Emily Hayes
The Epi proColon product screens for the presence in the blood of methylated septin 9 (mSEPT9) DNA; it is the only blood test cleared by the U.S. Food and Drug Administration (FDA) for colon cancer screening.
January 20, 2021
2019 10 01 18 58 9423 Colon2 400
FDA commissioner Hahn leaves agency
By Brian Casey
Hahn's departure was reported in the news media on January 19, and it was confirmed by the FDA in a tweet on January 20, the same day that President Joe Biden was sworn in. Woodcock is currently head of the FDA's Center for Drug Evaluation and Research (CDER).
January 19, 2021
2019 11 01 22 16 2253 Hahn Stephen 20191101221734
Northwell's SARS-CoV-2 LDT assay can test more patients at once
By LabPulse.com staff writers
The LDT can test 91 patients at a time for SARS-CoV-2, compared to a maximum of 29 patients who can be tested using the modified assay from the U.S Centers for Disease Control and Prevention (CDC). Northwell''s LDT real-time polymerase chain reaction (PCR) test targets the S gene of the SARS-CoV-2 virus and uses the same primers and probes for assay internal control as the modified CDC assay test, according to results published in the article (J Mol Diagn. December 2020. Vol. 22:12. pp. 1367-1372).
November 17, 2020
2020 05 07 22 45 7209 Lab Tech Coronavirus Sample 400
Report: LDT market to exceed $17B
By Bruce Carlson
The findings come from LabPulse.com sister company and IVD research firm Kalorama Information in a new report, "The Market for Clinical LDT Services and LDT Supplies." Kalorama noted that the LDT market is driven by relaxed regulatory activity and the need for improved cancer tests.
October 19, 2020
2019 07 26 20 46 7792 Lab Blood Woman 400
CMS to cut COVID-19 payments to slower labs
By Rebekah Moan
Under the new policy, labs that take longer than two days to complete COVID-19 tests will be paid $75 -- a 25% pay cut.
October 15, 2020
2020 10 16 22 39 6807 Dollar Money Coronavirus Mask 400
AACC: LDTs play crucial role in patient care
By Rebekah Moan
Furthermore, adding regulation by the U.S. Food and Drug Administration (FDA) would be duplicative, burdensome, and could stymie the ability of labs to respond quickly to new diseases like COVID-19.
October 15, 2020
2020 02 13 23 04 0191 Lab Scientists 400
CMS debuts new guide to streamline CLIA process for COVID-19
By LabPulse.com staff writers
The quick-start guide helps laboratories with the application process and includes information on the expedited review process. Labs also have a new option to pay CLIA certification fees on the CMS CLIA program website. Payments on the website are processed overnight, significantly faster than processing of hard-copy checks.
September 24, 2020
2020 03 28 00 41 4667 Newspaper 400
HHS: FDA review not needed for coronavirus LDTs
By Brian Casey
In the guidance, the HHS said that the FDA will not require labs to go through premarket review of LDTs for COVID-19 before they can be used on patients. Labs can choose to seek emergency use authorization (EUA) from the FDA if they wish, and the agency will adjudicate these submissions.
August 19, 2020
2020 01 27 21 38 4451 Lab 2019 Coronavirus Test 400
Previous Page
Page 3 of 8
Next Page