Latest news with #diagnostics
Zawya
4 days ago
- Health
- Zawya
Roche and the African Society for Laboratory Medicine (ASLM) launch partnership to strengthen diagnostic leadership across Africa
The partnership dubbed, Leadership Excellence for African Diagnostics (LEAD) between Roche and ASLM is a three-year programme to strengthen lab leadership in Africa The initiative focuses on mentorship and training to build lab leadership capabilities Roche Diagnostics Africa ( and the African Society for Laboratory Medicine (ASLM) ( have announced the launch of a three-year partnership to elevate laboratory leadership and improve access to quality diagnostic services across the continent. The initiative — titled LEAD: Leadership Excellence for African Diagnostics — brings together health ministries, laboratory directors, academic partners and technical experts to develop a new generation of capable, connected and future-ready lab leaders. 'This partnership will build long-term leadership that would shape the future of diagnostics in Africa — practically, strategically and sustainably. In a time where we need African healthcare systems to become less reliant on external funding sources, we are focused on increasing domestic diagnostics capacity more than ever,' says Dr Allan Pamba, Executive Vice President, Diagnostics, Africa, at Roche Diagnostics. 'We are entering a new chapter where African health systems take the lead in their own transformation. By growing diagnostic leadership we support long-term resilience and impact. LEAD equips professionals who can influence policy, drive national strategy and build sustainable healthcare capacity.' Under the partnership, LEAD will deliver a series of integrated interventions including baseline leadership assessments to guide a tailored context-specific training approach, development of a pan-African curriculum in collaboration with a leading academic institution, structured mentorship and professional development for emerging lab leaders, peer learning and regional collaboration through workshops and best practise exchanges. ASLM Chief Executive Officer, Nqobile Ndlovu, added: 'Diagnostics are the foundation of resilient health systems – but strong labs require strong leaders. LEAD focuses on people: their vision, their reach and their ability to transform public health from within. With this programme, we are supporting the leadership needed to move African healthcare forward.' Roche will provide funding, technical support and global platforms for visibility while ASLM will lead country-level implementation, stakeholder coordination and curriculum development. Laboratory strengthening is a key enabler for stronger health systems and this partnership is a commitment towards a healthier future for Africans. Distributed by APO Group on behalf of Roche Diagnostics. Media queries: Precious Nkabinde Communications Lead Nelly Rwenji Communications Lead ASLM nrwenji@ About Roche: Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit All trademarks used or mentioned in this release are protected by law. About ASLM: The African Society for Laboratory Medicine (ASLM) is a pan-African organization committed to achieving a healthier Africa by increasing access to quality laboratory services for all. We work to convene and mobilize stakeholders at all levels to improve access to diagnostic services and strengthen laboratory systems and networks. Since its founding in 2011, ASLM has played a key role in advancing laboratory medicine in Africa, collaborating with partners and stakeholders to promote disease diagnosis, surveillance, and control. Through its programs and initiatives, ASLM has contributed to the development of laboratory policies and guidelines, the expansion of laboratory networks, and the improvement of laboratory infrastructure and equipment. ASLM's experience highlights the importance of laboratory medicine in public health and demonstrates the impact of collaborative efforts in advancing health outcomes in Africa.
Yahoo
4 days ago
- Business
- Yahoo
Jim Cramer Notes Tempus AI is 'Losing Money Hand Over Fist'
Tempus AI, Inc. (NASDAQ:TEM) is one of the stocks on Jim Cramer's radar. Answering a caller's query about the company during the lightning round, Cramer said: 'Okay, another company that's just losing money hand over fist. I just can't go there. You know, when it comes to AI, you know what I believe in? I believe in NVIDIA.' A scientist inspecting the growth of cells, in the process of drug discovery. Tempus AI (NASDAQ:TEM) provides advanced healthcare technology solutions, including molecular diagnostics, data analytics platforms, and clinical trial matching services for the medical and life sciences sectors. The company's solutions support diagnostics, research, and oncology programs through tools like Insights, Lens, and Algos. A couple of months ago, when a caller inquired about the company, Cramer replied: 'Yeah, diagnostics with no money being made. We're not recommending stocks right now that are losing a lot of money because we think this could be a dicey environment, but [could] turn on a dime, that it's going to go fine right now, but I don't like companies that aren't making any money.' While we acknowledge the potential of TEM as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
News.com.au
4 days ago
- Business
- News.com.au
Why $487 million US distribution deal is a ‘watershed moment' for skyrocketing biotech Lumos
Lumos signs six-year exclusive deal valued at up to US$317 million with PHASE Scientific for distribution of FebriDX in US subject to CLIA waiver US$2 million payable immediately, comprising US$1 million exclusivity fee and US$1 million pre-paid purchase order Further US$1.5 million pre-paid purchase order will become payable on FebriDx CLIA waiver application to US FDA, expected within three months Lumos Diagnostics (ASX:LDX) has skyrocketed more than 150% after inking a landmark six-year distributor deal worth hundreds of millions of dollars to sell its rapid point-of-care diagnostic in the US market. The FebriDx product is a simple test able to differentiate between bacterial and non-bacterial acute respiratory infections. A lucrative US licencing deal with Hong-Kong based PHASE Scientific could see Lumos net up to to US$317m (~A$487m), and has been described as one of the largest distribution deals of its type to be done by an ASX-listed point-of-care diagnostics company. It's all positive for investors including Tenmile, a wholly-owned subsidiary of billionaire backers Andrew 'Twiggy' and Nicole Forest's private investment vehicle Tattarang. Tenmile is the largest shareholder of Lumos, holding 19.9% of the stock. PHASE backs cutting-edge test The deal assigns exclusive distribution rights to PHASE for the point-of-care blood test, which helps clinicians differentiate between a bacterial or viral respiratory infection within about 10 minutes. The agreement includes a US$1 million non-refundable exclusivity payment upon signing, along with an additional US$7.5m in non-refundable prepaid purchase orders, payable in three instalments including: US$1m upon signing of agreement US$1.5m upon submission of the FebriDx CLIA waiver application to the US Food and Drug Administration (FDA); and US$5m on granting of the US FDA CLIA waiver. Assuming PHASE achieves all payment milestones outlined and meets minimum order quantities, which are expected to "progressively ramp up", Lumos forecasts total value of the agreement reaching up to US$317m (~A$487m) over its six year duration. Lumos is currently undertaking a CLIA waiver study in the US to enable FebriDx to be used in a broader range of healthcare settings, including physician offices that do not operate under high-complexity laboratory certification. As of July 9, the study had enrolled 105 bacterial positive patients of the targeted 120 bacterial positive patient results required for the study. At the current accrual rate, the study is forecast to be completed during August with an FDA CLIA waiver application submitted about one month after completion. 'Watershed moment' Speaking with Stockhead from the US, Lumos managing director Doug Ward described the deal as transformational financially for the company, which listed on the ASX in July 2021. "I think this is a watershed moment for the business going forward," he said. "It will take hard work to realise everything but at the same time we have put ourselves in a great trajectory here to be very successful." As Lumos edges closer to wrapping up the CLIA waiver study, it has been quite the belle of the ball, attracting several suitors for its FebriDX distribution rights. "We selected PHASE for several reasons including they have a great understanding and experience in the US point-of-care market," Ward said. "While Hong Kong-based the majority of their sales are US based, and they know this point of care market very well." Ward said launching a brand-new product into the US market takes knowledge and experience of the landscape, but also financial commitment. "PHASE have made it clear of their intention to invest, and they just did a significant funding round in Hong Kong so have the means and commitment to make this happen," he said. "We also wanted to go with a company where we knew we were their primary focus so there were other companies which had more products in their bag, but we didn't want to be one of 50 or 100." Instead, Ward said he wanted to be one of small number of synergistic products for a distributor. "I think that hunger and focus is there, and PHASE should be very successful," he said. Non-executive chairman Sam Lanyon also praised PHASE and said he was confident the company would be a motivated partner to push the commercialisation of FebriDX in the US. Tapping into lucrative market opportunity Ward said in the US, point-of-care testing for respiratory illnesses like influenza and covid-19 represented a market worth more than US$1 billion, with strong demand for fast, accurate diagnostics in primary care and outpatient settings. "If you have a respiratory element to your sickness here in the US, you'll be immediately tested for covid or flu and we see FebriDX sitting side by side with those point-of care tests," Ward said. "The doctor can determine whether their patient does or doesn't have covid or flu and then whether their patient has a bacterial infection and needs antibiotics. "So, we don't need to teach doctors what we call a new care pathway but rather get them to be aware they can add FebriDX to their testing arsenal to assist with patient treatment." Lumos is tackling antimicrobial resistance (AMR) – the ability of microbes to resist the effects of medication – with FebriDX, which according to the World Health Organization is one of the top global public health threats. Ward said a significant contributor to the AMR crisis was the inappropriate prescribing of antibiotics, particularly for acute respiratory infections in primary care settings. "Our mission is to impact and improve the practice of medicine and we think FebriDX does that so we're very excited," he said. "It is something which is fresh, novel and should really improve care." Positioned to bring FebriDX to frontlines of care PHASE Scientific founder and CEO Dr Ricky Chiu said the company was proud to partner with Lumos as their exclusive US distributor for FebriDx, and to welcome the test into its INDICAID family, its trusted rapid diagnostics brand known for accessibility and quality. "With strong product differentiation and a CLIA waiver on the horizon, FebriDX is poised to transform the landscape of rapid respiratory diagnostics and clinical decision-making," Chiu said. "Backed by PHASE's record of having sold over 100 million INDICAID tests and a nationwide network of urgent care centres and clinics, we're uniquely positioned to bring this innovation to the frontlines of care — where speed, accuracy, and reliability matter most." At Stockhead, we tell it like it is. While Lumos Diagnostics is a Stockhead advertiser, it did not sponsor this article.
News.com.au
4 days ago
- Business
- News.com.au
Health Check: Lumos shares 150pc brighter after company-making US diagnostics deal
Lumos Diagnostics says its US distribution deal is worth up to $487 million Impedimed's US device sales are on a roll Noxopharm treats its first lupus trial patient In one of the 'largest distribution deals of its type' by an ASX-listed point-of-care diagnostics company, minnow Lumos Diagnostics (ASX:LDX) has inked a US compact worth up to US$317 million ($487 million) over six years. The agreement is with the Hong Kong-based Phase Scientific and relates to Lumos's lateral-flow assay, Febridx. With a finger prick blood sample, Febridx enables clinicians to differentiate between bacterial and non-bacterial acute respiratory infections in around 10 minutes. Lumos expects to sell Febridx under a mechanism called the CLIA (Clinical Laboratory Improvements Amendment ) waiver. The provision is for simple tests that have an insignificant risk of an erroneous result and can be used by less trained staff such as nurses and receptionists. Dissecting the deal As is always the case with such deals, the up-front amount is modest: US$2 million by way of a US$1 million exclusivity fee and a US$1 million pre-paid purchase order. Phase Scientific pays a further US$1.5 million from a further purchase order when Lumos lodges the CLIA waiver application. Investors should expect this within three months. There's then a further US$5 million pre-paid order if Lumos achieves the exemption. Between the second and sixth years, Phase's minimum order quantities gradually ramp up – and that's where the US$317 million comes into the picture. Put in context, Lumos was valued at a little over $20 million before this morning's 150% romp – handy pocket money for billionaire backers Andrew and Nicola Forrest, who hold 19.9% of LDX's stock. 'This agreement validates the value of the Febridx technology and provides a clear pathway to the US market, which we expect will accelerate rapidly,' says Lumos CEO Doug Ward. To support the requisite CLIA waiver application, Lumos is carrying out a supportive study which has enrolled 105 of the targeted 120 bacterial positive patients. Stretched US hospital funding is no impediment to Impedimed The US also is proving fertile ground for ImpediMed (ASX:IPD), with sales doubling in the June quarter. The maker of a lymphodema detection device called Sozo, Impedimed sold 44 units in the US in the quarter, compared with 22 in the March quarter. This included a nine-unit contract with Legacy Health, which has six hospitals and 70 primary care facilities across the east coast. Renewals during the quarter took total contract value (new and renewed contracts) to a record $6.3 million, 29% higher than the March stanza. 'Over the last year, Impedimed has seen a significant increase in leads and opportunities resulting from the initiatives implemented under the new leadership team,' the company says. Management expects a current level of sales in the current quarter, 'with improvement in subsequent quarters as the pipeline matures and additional internal initiatives take effect.' Lymphodema is swelling of the limbs, typically the arms and legs, usually caused by cancer treatments. Before Sozo came along, the condition was appraised with a tape measure. The sales uptick qualifies Impedimed for an additional US$5 million under a US$15 million debt facility, with specialist lender SWK Funding. Impedimed plans to release its quarterly numbers on July 31. Imugene targets $37.5 million equity raising Immuno-oncology play Imugene (ASX:IMU) has raised $22.5 million in an institutional placement and hopes for another $15 million by way of a share purchase plan. The whip 'round follows Monday's revelation of further strong clinical results from the company's phase 1b trial of its blood cancer therapy, Azer-cel. The funds will support a planned US pivotal trial. The company did the deal at 33 cents, a 22% discount to Monday's frozen price. Subscribers receive a free option on a three-for-four basis, exercisable at 43 cents after March next year. On exercise of those options, investors receive one-for-one piggyback oppies, exercisable at 86 cents. The raising takes Imugene's cash kitty to $64 million. Noxopharm hopes that HERACLES will slay lupus Noxopharm (ASX:NOX) has dosed the first patient in its first-in-human trial of its drug candidate for the painful autoimmune disease lupus. Dubbed HERACLES, the dose escalation study aims to evaluate the safety and tolerability profile of its candidate, SOF-SKN. Lupus affects about five million people globally – 90% of them women. The HERACLES trial targets cutaneous lupus erythematosus (CLE), the most common form. This is when body's immune system mistakenly attacks skin cells, causing inflammation and skin lesions and sores. SOF-SKN modulates inflammation at its source. 'The global lupus market is worth more than US$3 billion and is expected to grow significantly over the coming years,' Noxopharm CEO Dr Gisela Mautner says. SOF-SKN is an exponent of the company's core tech Sofra, acquired from the Hudson Institute of Medical Research. Noxopharm hopes to apply the core Sofra tech to rheumatoid arthritis, type 1 diabetes, inflammatory bowel disease and dementia (which also is immune related). HERACLES stands for 'harnessing endogenous regulation against CLE study'. Heracles was famed in Greek mythology for his immense strength, courage and ability to slay monsters. Along with a bucket of money, these are all prerequisites for drug development. August 1 D-day for Trump tariff drug slug? It's hard to distinguish Donald Trump's genuine intentions from his brain farts, but it looks like the global pharma sector should expect some movement on his threatened pharma tariff by August 1. Trump told reporters that along with a tariff on semiconductors, he should announce the drug impost 'probably at the end of the month'. 'We're going to start off with a low tariff and give the pharmaceutical companies a year or so to build, and then we're going to make it a very high tariff,' the Prez said. Drug makers can avoid the tariff – mooted to be up to 200% – by moving drug manufacturing to US shores. As reported, CSL is the most likely ASX drug stock in the firing line. But given the maker of plasma derived therapeutics draws on US blood donors and has some US manufacturing, the repercussions are as clear as Trump's Ukraine peace plan.
Yahoo
5 days ago
- Business
- Yahoo
Waters, BD biosciences unit agree to $17.5B merger
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. Waters has agreed to combine with BD's biosciences and diagnostic solutions business in a deal valued at about $17.5 billion, the companies said Monday. The combined company will continue to operate under the Waters name and retain its listing on the New York Stock Exchange. The BD business will be spun off generally tax-free to BD shareholders and simultaneously merged with a subsidiary of Waters, through a structure known as a Reverse Morris Trust. Waters CEO Udit Batra will lead the new entity, and Waters' headquarters will remain in Milford, Massachusetts. The transaction doubles Waters' total addressable market to about $40 billion, with an annual growth rate of 5% to 7%, according to the statement. Waters shares fell more than 11% to $313.66 in early NYSE trading on Monday, while BD shares were down about 1% at $174.12. BD in February revealed its intention to separate the biosciences and diagnostics business, which generated $3.4 billion in revenue in BD's 2024 financial year. The merger with Waters creates a combined company with expected 2025 sales of about $6.5 billion. Under the agreement, BD shareholders will own about 39.2% of the combined company and Waters the other 60.8%. BD will also receive a cash distribution of about $4 billion before the combination is completed. Waters is expected to assume approximately $4 billion of debt. Waters will acquire both the flow cytometry and the microbiology business of BD, Leerink Partners analyst Puneet Souda said in a report to clients. 'Though BD's flow cytometry is [a] uniquely differentiated and leading business, we don't expect investors to view the deal attractively in the near-term given the dilution and now higher exposure to microbiology,' Souda wrote. Jefferies analyst Tycho Peterson said he expected Waters shares to trade lower due to the deal size and other variables, but longer term saw merits to the transaction including the ability to create scale and an attractive margin profile. The deal is expected to close near the end of the first quarter of calendar year 2026, subject to regulatory approvals, Waters shareholder approval and other closing conditions. Jeff Jonas, portfolio manager at Gabelli Funds, said the merger does not put too much debt on the combined company, which will allow smaller dealmaking to continue. 'It's a good fit for Waters that gets them closer to Thermo Fisher and Danaher in terms of size and scale,' Jonas said in an email. Recommended Reading BD plans split from life science business to fuel medtech investment Sign in to access your portfolio
