CLIA

Journey Biosciences launches NaviDKD™ for people with diabetes to predict long-term kidney complications

Retrieved on: 
Thursday, December 1, 2022

LEBANON, N.H., Dec. 1, 2022 /PRNewswire/ -- Journey Biosciences, Inc., a biotechnology company offering biomarker-based predictive risk screening technologies for diabetes-related complications, today announced the launch of its flagship product NaviDKD.

Key Points: 
  • LEBANON, N.H., Dec. 1, 2022 /PRNewswire/ -- Journey Biosciences, Inc. , a biotechnology company offering biomarker-based predictive risk screening technologies for diabetes-related complications, today announced the launch of its flagship product NaviDKD.
  • NaviDKD, a biomarker-based blood test, proactively assesses the risk of kidney disease in people with diabetes years before clinical signs or symptoms appear.
  • Along with its proprietary Compass reporting platform, NaviDKD provides actionable insights for preventing and managing kidney complications before they occur.
  • "For the one-in-three people with diabetes who will develop diabetic kidney disease, NaviDKD provides an opportunity to fundamentally change their ultimate health outcomes," said Adam Graybill, Chief Executive Officer of Journey Biosciences.

Theralink® Technologies Accepted to Present Two Posters at the Upcoming San Antonio Breast Cancer Symposium

Retrieved on: 
Thursday, December 1, 2022

GOLDEN, Colo., Dec. 1, 2022 /PRNewswire/ -- Theralink Technologies (OTC: THER) ("Theralink" or the "Company"), a precision oncology company with a novel quantitative protein and phosphoprotein-based assay for breast cancer, today announced the acceptance of two poster presentations evaluating the potential use and utility of its novel RPPA (Reverse Phase Protein Array) technology at the San Antonio Breast Cancer Symposium (SABCS) 2022.

Key Points: 
  • Mick Ruxin M.D., CEO of Theralink Technologies stated, "We are so pleased to have multiple poster presentations accepted at SABCS this year.
  • During our presentations we will highlight the potential of our innovative RPPA-based technology for clinical molecular profiling of breast cancer patients.
  • The Theralink Assay for Advanced Breast Cancer can provide additional levels of quantified clarity for patients who need it the most."
  • The Theralink management team welcomes the opportunity to meet with you in-person in San Antonio at SABCS 2022.

CENTOGENE to Participate in Upcoming Conferences in December

Retrieved on: 
Thursday, December 1, 2022

CENTOGENEs mission is to provide data-driven, life-changing answers to patients, physicians, and pharma companies for rare and neurodegenerative diseases.

Key Points: 
  • CENTOGENEs mission is to provide data-driven, life-changing answers to patients, physicians, and pharma companies for rare and neurodegenerative diseases.
  • We integrate multiomic technologies with the CENTOGENE Biodatabank providing dimensional analysis to guide the next generation of precision medicine.
  • Since our founding in 2006, CENTOGENE has been offering rapid and reliable diagnosis building a network of approximately 30,000 active physicians.
  • To date, the CENTOGENE Biodatabank has contributed to generating novel insights for more than 260 peer-reviewed publications.

ProPhase Labs to Present at the Planet MicroCap Showcase: VIRTUAL 2022 on Wednesday, December 7, 2022

Retrieved on: 
Wednesday, November 30, 2022

GARDEN CITY, NY, Nov. 30, 2022 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH), a growth oriented and diversified diagnostics, genomics and biotech company, today announced that it will be presenting at the Planet MicroCap Showcase: VIRTUAL 2022 on Wednesday, December 7, 2022 at 2:30 pm EST.

Key Points: 
  • GARDEN CITY, NY, Nov. 30, 2022 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH), a growth oriented and diversified diagnostics, genomics and biotech company, today announced that it will be presenting at the Planet MicroCap Showcase: VIRTUAL 2022 on Wednesday, December 7, 2022 at 2:30 pm EST.
  • The Company provides traditional CLIA molecular laboratory services, including COVID-19 testing.
  • ProPhase Diagnostics also offers best-in-class rapid antigen and antibody/immunity tests to broaden its COVID-19 testing beyond RT-PCR testing.
  • ProPhase BioPharma, Inc. (PBIO), a wholly owned subsidiary of ProPhase, was formed for the licensing, development and commercialization of novel drugs and compounds.

AnPac Announces Regaining Compliance with Nasdaq Listing Requirement

Retrieved on: 
Wednesday, November 30, 2022

On June 9, 2022, AnPac Bio-Medical Science Co., Ltd. (the Company) received the determination from The Nasdaq Stock Market LLC (Nasdaq) that the Company has regained compliance with the requirements to remain listed in The Nasdaq Capital Market subject to a one-year Mandatory Panel Monitor of the Companys ongoing compliance with such requirements as set force in Listing Rule 5815(d)(4)(B).

Key Points: 
  • On June 9, 2022, AnPac Bio-Medical Science Co., Ltd. (the Company) received the determination from The Nasdaq Stock Market LLC (Nasdaq) that the Company has regained compliance with the requirements to remain listed in The Nasdaq Capital Market subject to a one-year Mandatory Panel Monitor of the Companys ongoing compliance with such requirements as set force in Listing Rule 5815(d)(4)(B).
  • The Company will have the opportunity to respond/present to the Hearings Panel as provided by Listing Rule 5815(d)(4)(C).
  • This request was due to a Staff determination letter (the Letter) on September9, 2022 from the Listing Qualifications Department of The Nasdaq Stock Market LLC (Nasdaq) notifying the Company of the Staffs determination to delist the Companys securities from The Nasdaq Capital Market due to the Companys failure to regain compliance with the $1 per share bid price requirement of Listed Securities required for continued listing as set forth in Listing Rule5450(a)(1)(the $1 Bid Rule), following the 180 calendar day compliance period set forth in Listing Rule5810(c)(3)(A)(the Compliance Period).
  • On September16, 2022, Company received a letter from Nasdaq granting the appeal and scheduling the Nasdaq Hearings Panel for October20, 2022.

SmartHealth Diagnostics Appoints Accomplished Corporate and Finance Leader Mitch Levine as President, Chief Financial Officer, and Director

Retrieved on: 
Tuesday, November 29, 2022

IRVINE, Calif., Nov. 29, 2022 /PRNewswire/ -- SmartHealth Diagnostics, Inc. ("SHDx" or "the Company"), formerly Predictive Health Diagnostics Company, a leading developer of precision diagnostics that address unmet clinical needs in vascular, metabolic, and oncological diseases, today announced the appointment of Mitch Levine as President, Chief Financial Officer, and member of the Board of Directors.

Key Points: 
  • Mr. Levine brings a combined 40 years of strategic leadership experience in corporate life sciences, investment management, and investment banking, including extensive expertise in fundraising for growth-stage companies.
  • Prior to joining SmartHealth Diagnostics, Mr. Levine spent five years as CFO of Oncocyte Corp., a Nasdaq-listed molecular diagnostics company, and is currently an advisor.
  • He also was responsible for creating a critical licensing and tech transfer agreement with one of China's largest and fastest growing diagnostic labs.
  • In his early career, Mr. Levine held roles of progressive responsibility with Bear Stearns and Lehman Brothers.

KSL | Pulse Scientific Named National Distributor in Canada for First-of-its-Kind COVID-19 & Flu At-Home Molecular Test

Retrieved on: 
Tuesday, November 29, 2022

The Lucira COVID-19 & Flu Test is a 99% accurate rapid molecular test that delivers results in 30 minutes or less from one shallow nasal swab.

Key Points: 
  • The Lucira COVID-19 & Flu Test is a 99% accurate rapid molecular test that delivers results in 30 minutes or less from one shallow nasal swab.
  • View the full release here: https://www.businesswire.com/news/home/20221129005267/en/
    KSL | Pulse Scientific named national distributor in Canada for first-of-its-kind Covid-19 & Flu at-home molecular test.
  • Developed by Lucira Health, this 99% accurate test approved by Health Canada is now available for the COVID/Flu season.
  • Because Australia had an alarming spike in COVID and flu cases and we could see a substantial increase in North America.

The Deerborne Group to Attend 45th Annual San Antonio Breast Cancer Symposium (SABCS) December 6-10, 2022

Retrieved on: 
Tuesday, November 29, 2022

SAN DIEGO, Nov. 29, 2022 /PRNewswire/ -- The Deerborne Group, a global boutique management consulting firm, today announced they will attend the 45th Annual San Antonio Breast Cancer Symposium being held at the Henry B. Gonzalez Convention Center in San Antonio, TX from December 6-10, 2022.

Key Points: 
  • SAN DIEGO, Nov. 29, 2022 /PRNewswire/ -- The Deerborne Group, a global boutique management consulting firm, today announced they will attend the 45th Annual San Antonio Breast Cancer Symposium being held at the Henry B. Gonzalez Convention Center in San Antonio, TX from December 6-10, 2022.
  • The Deerborne Group is a boutique management consulting firm that focuses exclusively on the global biotechnology, in-vitro diagnostics, and life sciences industries.
  • Our primary focus is advising corporations, venture capital, and private equity firms on commercial, operations, and corporate strategy.
  • We do this by helping them identify opportunities, minimize risks, and how best to navigate some of their most difficult management challenges.

UAB Cardiogenomics Clinic and Allelica to perform polygenic risk score clinical implementation study

Retrieved on: 
Tuesday, November 29, 2022

NEW YORK, Nov. 29, 2022 /PRNewswire/ -- The UAB Cardiogenomics Clinic, led by Dr. Pankaj Arora, is partnering with the industry leader for polygenic risk score (PRS) analysis and reporting, Allelica Inc., to perform a clinical implementation study on PRS application for coronary artery disease. The aim of the study is to develop a clear path forward for the clinical implementation of PRS in cardiovascular disease prevention.

Key Points: 
  • The Cardiogenomics Clinic at the University of Alabama at Birmingham and Allelica are partnering to perform a clinical implementation study to assess how polygenic risk score integration changes clinical management and health outcomes in a US health system.
  • NEW YORK, Nov. 29, 2022 /PRNewswire/ -- The UAB Cardiogenomics Clinic, led by Dr. Pankaj Arora, is partnering with the industry leader for polygenic risk score (PRS) analysis and reporting, Allelica Inc., to perform a clinical implementation study on PRS application for coronary artery disease.
  • The aim of the study is to develop a clear path forward for the clinical implementation of PRS in cardiovascular disease prevention.
  • The results of this study will help to establish a clear pathway for providers for the clinical implementation of PRS in cardiovascular disease risk management and prevention.

Chembio Announces FDA CLIA Waiver Submission for DPP HIV-Syphilis System

Retrieved on: 
Monday, November 28, 2022

We are pleased to communicate that our DPP HIV-Syphilis System has been submitted to FDA for CLIA waiver.

Key Points: 
  • We are pleased to communicate that our DPP HIV-Syphilis System has been submitted to FDA for CLIA waiver.
  • Upon receipt of CLIA waiver, we believe this will represent a large step forward in rapid testing for sexually transmitted infections.
  • We appreciate the collaboration with the FDA on this submission and look forward to continued dialog regarding our CLIA waiver application, said RichardL.
  • Chembios portfolio of DPP-based point-of-care tests with FDA regulatory approvals include the DPP HIV-Syphilis System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System (EUA).